Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-28 @ 7:01 PM
Study NCT ID:
NCT04526834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-20
First Post:
2020-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}, {'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}, {'id': 'D054391', 'term': 'Lymphoma, Extranodal NK-T-Cell'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2036-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-18', 'studyFirstSubmitDate': '2020-08-20', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose', 'timeFrame': 'Day 0 to 28 for DLT', 'description': 'Incidence of DLTs and occurrence of study related adverse events'}], 'secondaryOutcomes': [{'measure': 'To evaluate pharmacokinetics of autologous CD30.CAR-T', 'timeFrame': 'Start of infusion of CD30.CAR-T (Day 0) until year 5', 'description': 'AUC (copies/ug DNA over time)'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Start of CD30.CAR-T (Day 0) until progressive disease or start of new cancer therapy, whichever comes first, up to one year', 'description': 'ORR'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year', 'description': 'DOR'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year', 'description': 'PFS'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CD30, r/r NHL, DLBCL, ALCL, ENKTCL, PMBCL, PTCL, adult'], 'conditions': ['Anaplastic Large Cell Lymphoma', 'Peripheral T Cell Lymphoma', 'Extranodal NK/T-cell Lymphoma', 'Diffuse Large B Cell Lymphoma', 'Primary Mediastinal Large B-Cell Lymphoma (PMBCL)']}, 'referencesModule': {'references': [{'pmid': '34515338', 'type': 'DERIVED', 'citation': 'Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma', 'detailedDescription': 'Adult patients with relapsed or refractory CD30-positive Non-Hodgkin Lymphoma who have failed standard available therapies and who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells.\n\nCD30.CAR-T cells will be infused once following the completion of lymphodepleting chemotherapy with Bendamustine and Fludarabine.\n\nSubjects will be closely monitored for DLT and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEligibility is determined priori to leukapheresis. Patients must satisfy the following criteria to be enrolled in this study:\n\n1. Signed Informed Consent Form\n2. Male or female patients who are 18-75 years of age\n3. Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL\n4. Relapsed or refractory CD30-positive NHL who have failed all available standards of therapy. Patients may or may not have received an autologous or allogeneic HSCT CD30-positive tumor\n5. At least 1 measurable lesion according to the Lugano Classification\n6. ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy \\>12 weeks\n\nExclusion Criteria:\n\n1. CNS involvement by malignancy\n2. Inadequate laboratory abnormalities at screening:\n\n Hgb ≤ 8.0 g/dL Total bilirubin \\> 1.5 x ULN (\\>2 x ULN for patients with Gilbert's syndrome) AST and ALT ≥ 5 x ULN CrCL ≤ 45 mL/min (as measured by Cockcroft-Gault equation) ANC ≤ 1000/uL Platelets ≤75,000/uL PR or INR \\>1.5 x ULN aPTT\\> 1.5 x ULN\n3. Active uncontrolled bleeding or a known bleeding diathesis\n4. Inadequate pulmonary function defined as pulse oximetry \\< 90% on room air\n5. Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (\\>10 mg/day prednisone or equivalent for \\>48 hours)\n6. Received prior therapy of:\n\n Anti-CD30 Ab based therapy within the previous 8 weeks Previous CD30.CAR-T investigational product Bi-specific CD30 Ab within the previous 8 weeks Allogenic HSCT in the last 180 days Autologous HSCT within 90 days\n7. Active GVHD requiring immune suppression regardless of grade\n8. HIV positive\n9. Active HBV and/or HCV"}, 'identificationModule': {'nctId': 'NCT04526834', 'acronym': 'CERTAIN', 'briefTitle': 'Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tessa Therapeutics'}, 'officialTitle': 'Phase 1 Study of CD30-Directed Genetically Modified Autologous T-Cells (CD30.CAR-T) in Patients With Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'TESSCAR002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD30 positive NHL subtypes', 'description': '(ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL)\n\nDose Level 1\n\nDose Level 2\n\nDose Level 3', 'interventionNames': ['Drug: CD30.CAR-T']}], 'interventions': [{'name': 'CD30.CAR-T', 'type': 'DRUG', 'otherNames': ['CD30-directed genetically modified autologous T cells'], 'description': 'Bendamustine and Fludarabine (3 days)\n\nDose level 1: 2 x 108 cell/m2 CD30.CAR-T (Day 0)\n\nDose level 2: 4 x 108 cell/m2 CD30.CAR-T (Day 0)\n\nDose level 3: 6 x 108 cell/m2 CD30.CAR-T (Day 0)', 'armGroupLabels': ['CD30 positive NHL subtypes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Centre', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sairah Ahmed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD Anderson'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tessa Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}