Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898543
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2021-05-10
Brief Title:
QUILT-3076 Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors
Sponsor:
ImmunityBio Inc
Organization:
ImmunityBio Inc
Study Overview
Official Title:
Phase 1 Open-Label Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a two-part open-label phase 1 study to evaluate safety and preliminary efficacy of M-CENK Suspension for Infusion Cryopreserved and N-803 for subcutaneous administration in subjects with locally advanced or metastatic solid tumors The study consists of two cohorts cohort 1 includes subjects with either newly diagnosed solid tumors who have not received prior therapy or subjects who have received prior first line treatment and cohort 2 that includes subjects with relapsedrefractory rr solid tumors who have progressive disease after receiving 2 prior therapies The two cohorts will be conducted simultaneously
Detailed Description:
Both cohorts will be enrolled simultaneously Both cohorts have a part A apheresis and cohort 2 has a part B M-CENK treatment one bag has a 100 mL cell suspension containing 025 to 075 x 109 cells and N-803 treatment
Up to 40 subjects may be enrolled in cohort 1 Subjects in cohort 1 will participate in apheresis collection of MNCs prior to receiving disease specific first-line therapy per primary oncologists recommendations Subjects who have completed apheresis in cohort 1 may subsequently enroll in cohort 2 part B if they have progressive disease after 2 prior therapies or if they have progressive disease within 12 months of receiving neoadjuvant or adjuvant chemotherapy
They must also meet the inclusion criteria to participate in the treatment phase cohort 2 part B Additionally all subjects will be re-evaluated to confirm that they still meet the specified eligibility criteria once the M-CENK cells are manufactured and prior to the first administration of M-CENK The Sponsor will approve the subjects continued eligibility prior to receiving the manufactured M-CENK cells
Up to 21 subjects may be enrolled in cohort 2 part A so that up to 11 subjects receive at least 1 dose of M-CENK A dose is a single administration of M-CENK cells or a single administration of N-803 Subjects in cohort 2 part A will undergo an apheresis collection of MNCs prior to receiving approximately 4 weeks of disease-specific therapy per oncologists recommendations while the M-CENK cells are being manufactured for use in the treatment phase cohort 2 part B Subjects will be evaluated for eligibility in inclusionexclusion criteria prior to enrollment into part B Additionally all subjects will be re-evaluated to confirm that they still meet the specified eligibility criteria once the M-CENK cells are manufactured and prior to the first administration of M-CENK The Sponsor will approve the subjects continued eligibility prior to receiving the manufactured M-CENK cells
M-CENK cells manufactured from the autologous apheresis product may be administered up to 10 times weekly starting on study day 1 with a minimum of 7 days between each M-CENK dose depending on the availability of cells and that there is no contra-indication to administer cells Subjects will receive up to 5 doses of N-803 SC every 2 weeks prior to every other dose of M-CENK ie odd number M-CENK dosesThe treatment may be administered for up to 10 doses of M-CENK if the subject tolerates treatment the doses of M-CENK cells are available and the Investigator believes there may be potential benefit to the subject
Safety endpoints include assessments of TEAEs SAEs and clinically significant changes in safety laboratory tests and vital signs Toxicities will be graded using CTCAE Version 50 or in the case of CRS using a specified grading system Safety will be monitored throughout the study
The treatment of the initial 3 subjects in cohort 2 part B will be staggered with at least a 2-week interval between each subject After the first 3 subjects in cohort 2 part B are treated the treatment of existing subjects in cohort 2 part B will be paused after the 14-day toxicity assessment period for a safety evaluation by the Safety Review Committee SRC Based on the SRC safety evaluation the treatment of the subsequent subjects can proceed if the safety evaluation from the initial 3 subjects in part B suggests that the therapy is safe There will be another safety review after all subjects in cohort 2 have completed the 14-day toxicity assessment period
Up to 40 subjects may be enrolled in cohort 1 Subjects in cohort 1 will participate in apheresis collection of MNCs prior to receiving disease specific first-line therapy per primary oncologists recommendations Subjects who have completed apheresis in cohort 1 may subsequently enroll in cohort 2 part B if they have progressive disease after 2 prior therapies or if they have progressive disease within 12 months of receiving neoadjuvant or adjuvant chemotherapy
They must also meet the inclusion criteria to participate in the treatment phase cohort 2 part B Additionally all subjects will be re-evaluated to confirm that they still meet the specified eligibility criteria once the M-CENK cells are manufactured and prior to the first administration of M-CENK The Sponsor will approve the subjects continued eligibility prior to receiving the manufactured M-CENK cells
Up to 21 subjects may be enrolled in cohort 2 part A so that up to 11 subjects receive at least 1 dose of M-CENK A dose is a single administration of M-CENK cells or a single administration of N-803 Subjects in cohort 2 part A will undergo an apheresis collection of MNCs prior to receiving approximately 4 weeks of disease-specific therapy per oncologists recommendations while the M-CENK cells are being manufactured for use in the treatment phase cohort 2 part B Subjects will be evaluated for eligibility in inclusionexclusion criteria prior to enrollment into part B Additionally all subjects will be re-evaluated to confirm that they still meet the specified eligibility criteria once the M-CENK cells are manufactured and prior to the first administration of M-CENK The Sponsor will approve the subjects continued eligibility prior to receiving the manufactured M-CENK cells
M-CENK cells manufactured from the autologous apheresis product may be administered up to 10 times weekly starting on study day 1 with a minimum of 7 days between each M-CENK dose depending on the availability of cells and that there is no contra-indication to administer cells Subjects will receive up to 5 doses of N-803 SC every 2 weeks prior to every other dose of M-CENK ie odd number M-CENK dosesThe treatment may be administered for up to 10 doses of M-CENK if the subject tolerates treatment the doses of M-CENK cells are available and the Investigator believes there may be potential benefit to the subject
Safety endpoints include assessments of TEAEs SAEs and clinically significant changes in safety laboratory tests and vital signs Toxicities will be graded using CTCAE Version 50 or in the case of CRS using a specified grading system Safety will be monitored throughout the study
The treatment of the initial 3 subjects in cohort 2 part B will be staggered with at least a 2-week interval between each subject After the first 3 subjects in cohort 2 part B are treated the treatment of existing subjects in cohort 2 part B will be paused after the 14-day toxicity assessment period for a safety evaluation by the Safety Review Committee SRC Based on the SRC safety evaluation the treatment of the subsequent subjects can proceed if the safety evaluation from the initial 3 subjects in part B suggests that the therapy is safe There will be another safety review after all subjects in cohort 2 have completed the 14-day toxicity assessment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None