Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 10:11 AM
Study NCT ID:
NCT04142359
Status:
TERMINATED
Last Update Posted:
2024-12-10
First Post:
2019-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582303', 'term': 'ALT-803'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bobby.Reddy@Immunitybio.com', 'phone': '855-797-9277', 'title': 'Sandeep Bobby Reddy, Chief Medical Officer', 'organization': 'ImmunityBio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Any AEs that occurred during the sub-study and were associated with QUILT-3.032 were to be collected and handled per the QUILT-3.032 protocol. This PK sub-study was designed to evaluate the pharmacokinetic (PK) profile of intravesical N-803 in combination with BCG in patients with high grade NMIBC. All AEs were to be reported in the respective main studies, and the only data collected in this study were related to the primary endpoints in QUILT-3.032-2.005-PK.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A: CIS (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nBCG in Combination with N-803: BCG in Combination with N-803', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease\n\nBCG in Combination with N-803: BCG in Combination with N-803', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nN-803 alone: N-803 alone', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Half-life (t½)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: CIS (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG001', 'title': 'Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG002', 'title': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nN-803 alone: N-803 alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Half-life (t½)', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.'}, {'type': 'PRIMARY', 'title': 'Apparent (Extravascular) Volume of Distribution (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: CIS (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG001', 'title': 'Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG002', 'title': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nN-803 alone: N-803 alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Apparent (extravascular) volume of distribution (Vz/F)', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.'}, {'type': 'PRIMARY', 'title': 'Apparent (Extravascular) Clearance (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: CIS (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG001', 'title': 'Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG002', 'title': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nN-803 alone: N-803 alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Apparent (extravascular) clearance (CL/F)', 'unitOfMeasure': 'L/day/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: CIS (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG001', 'title': 'Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG002', 'title': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nN-803 alone: N-803 alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Maximum observed concentration (Cmax)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.'}, {'type': 'PRIMARY', 'title': 'Time of the Observed Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: CIS (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG001', 'title': 'Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG002', 'title': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nN-803 alone: N-803 alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Time of the observed maximum concentration (Tmax)', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Curve From Time 0 Through the Last Measurable Concentration (AUC0-t)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: CIS (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG001', 'title': 'Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG002', 'title': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nN-803 alone: N-803 alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t)', 'unitOfMeasure': 'Day*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Curve From Time 0 Extrapolated to Infinite Time (AUC0-inf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: CIS (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG001', 'title': 'Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'OG002', 'title': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nN-803 alone: N-803 alone'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf)', 'unitOfMeasure': 'Day*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A: CIS (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'FG001', 'title': 'Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'FG002', 'title': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nN-803 alone: N-803 alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A: CIS (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'BG001', 'title': 'Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease\n\nBCG in Combination with N-803: BCG in Combination with N-803'}, {'id': 'BG002', 'title': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].\n\nN-803 alone: N-803 alone'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': 'NA', 'comment': 'Only 1 participant was enrolled in the study.', 'groupId': 'BG000'}, {'value': '73', 'spread': 'NA', 'comment': 'Only 1 participant was enrolled in the study.', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Non-muscle invasive bladder cancer enrolled on either QUILT-3.032 or QUILT-2.005', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Only 1 participant was enrolled in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-24', 'size': 1375619, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-25T11:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study was closed due to the recent pandemic and enrollment challenges.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2019-10-23', 'resultsFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2019-10-25', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-05', 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Half-life (t½)', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Half-life (t½)'}, {'measure': 'Apparent (Extravascular) Volume of Distribution (Vz/F)', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Apparent (extravascular) volume of distribution (Vz/F)'}, {'measure': 'Apparent (Extravascular) Clearance (CL/F)', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Apparent (extravascular) clearance (CL/F)'}, {'measure': 'Maximum Observed Concentration (Cmax)', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Maximum observed concentration (Cmax)'}, {'measure': 'Time of the Observed Maximum Concentration (Tmax)', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Time of the observed maximum concentration (Tmax)'}, {'measure': 'Area Under the Plasma Concentration Curve From Time 0 Through the Last Measurable Concentration (AUC0-t)', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t)'}, {'measure': 'Area Under the Plasma Concentration Curve From Time 0 Extrapolated to Infinite Time (AUC0-inf)', 'timeFrame': 'Study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.', 'description': 'Area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8096327/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14)', 'detailedDescription': 'QUILT-3.032 is a Phase 2, open-label, single-arm, three-cohort, multicenter study of intravesical BCG plus ALT-803 in patients with BCG unresponsive high grade NMIBC. Patients will be enrolled into one of three study cohorts. Cohort A will enroll 80 patients who have histologically confirmed presence of BCG-unresponsive carcinoma in situ (CIS) \\[with or without Ta or T1 disease\\]. Cohort B will enroll 80 patients who have histologically confirmed BCG-unresponsive high-grade Ta or T1 disease. Cohort C will enroll up to 23 patients who also have histologically confirmed presence of BCG-unresponsive CIS \\[with or without Ta/T1 papillary disease\\]. Patients in Cohorts A and B will receive ALT-803 plus BCG combination treatment. Patients in Cohort C will receive ALT-803 alone. Enrollment of Cohort C will start once the enrollment of Cohort A is complete. Cohorts A, B, and C are independent study cohorts and will be separately evaluated for efficacy. All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus ALT-803 or ALT-803 alone weekly for 6 consecutive weeks during the induction treatment period.\n\nQUILT-2.005 is a phase 2b, randomized, two-cohort, open-label, multicenter study of intravesical ALT-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC. Patients will be enrolled into one of two study cohorts and randomized into two arms to be treated with either ALT-803 plus BCG or BCG alone. Cohort A will initially enroll 366 patients who have histologically confirmed CIS (with or without Ta/T1 papillary disease). Cohort B will initially enroll 230 patients who have histologically confirmed high-grade papillary Ta/T1 disease only. Cohorts A and B are two independent study cohorts and will be evaluated separately for efficacy.\n\nPK sub-study: Blood samples to determine serum levels of ALT-803 will be collected on study day 1 prior to dosing, and at post-bladder voiding (+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6. Six subjects from either cohort A (either study) or cohort C (QUILT 3.032) and six subjects from cohort B (either study) will be sampled initially. Up to an additional 4 subjects for each cohort may also be sampled. Patients enrolled in QUILT 2.005 must have been randomized to receive ALT-803 plus BCG to be eligible for the PK sub-study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Six subjects from either Cohort A (either study) or Cohort C (QUILT-3.032) and six subjects from Cohort B (either study) will be sampled initially in this PK sub-study. Up to an additional 4 subjects from each cohort may also be sampled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only subjects who are eligible for and have entered into protocol QUILT-3.032 or QUILT-2.005 may participate in this sub-study.\n* Patients enrolled in QUILT-2.005 must have been randomized to receive ALT-803 plus BCG to participate in this sub-study.\n\nExclusion Criteria:\n\n* Refusal to provide voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations.\n* Loss of ≥ 475 mL blood volume or blood transfusion of any blood product within 3 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT04142359', 'briefTitle': 'PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Altor BioScience'}, 'officialTitle': 'A Pharmacokinetic Sub-Study of QUILT-3.032 (CA ALT-803-01-16): A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer and QUILT-2.005: A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'QUILT-3.032-2.005-PK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A: CIS (either study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].', 'interventionNames': ['Biological: BCG in Combination with N-803']}, {'label': 'Cohort B: High-Grade Ta/T1 Papillary Disease (either study)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease', 'interventionNames': ['Biological: BCG in Combination with N-803']}, {'label': 'Cohort C: CIS (QUILT-3.032)', 'description': 'Patients with histologically confirmed presence of BCG-unresponsive CIS, \\[with or without Ta/T1 papillary disease\\].', 'interventionNames': ['Drug: N-803 alone']}], 'interventions': [{'name': 'BCG in Combination with N-803', 'type': 'BIOLOGICAL', 'otherNames': ['N-803'], 'description': 'BCG in Combination with N-803', 'armGroupLabels': ['Cohort A: CIS (either study)', 'Cohort B: High-Grade Ta/T1 Papillary Disease (either study)']}, {'name': 'N-803 alone', 'type': 'DRUG', 'description': 'N-803 alone', 'armGroupLabels': ['Cohort C: CIS (QUILT-3.032)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Department of Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Adult & Pediatric Urology', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Winthrop University Hospital Department of Urology', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Medical Research', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Urology', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Chad Garner, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ImmunityBio, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altor BioScience', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}