Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA2) (ALPHA2)
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| ClinicalTrials.gov Identifier: NCT04416984 |
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Recruitment Status :
Recruiting
First Posted : June 4, 2020
Last Update Posted : April 8, 2022
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Sponsor:
Allogene Therapeutics
Information provided by (Responsible Party):
Allogene Therapeutics
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Brief Summary:
The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsed/Refractory Large B Cell Lymphoma | Genetic: ALLO-501A Biological: ALLO-647 Drug: Fludarabine Drug: Cyclophosphamide | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL) |
| Actual Study Start Date : | May 21, 2020 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: ALLO-501A, ALLO-647 |
Genetic: ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19 Biological: ALLO-647 ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen Drug: Fludarabine Chemotherapy for lymphodepletion Drug: Cyclophosphamide Chemotherapy for lymphodepletion |
Primary Outcome Measures :
- Phase 1: Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501A [ Time Frame: 28 days ]Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion
- Phase 1: Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501A [ Time Frame: 33 days ]Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse.
- At least 1 measurable lesion at time of enrollment.
- Relapsed or refractory disease after at least 2 lines of chemotherapy
- ECOG performance status 0 or 1.
- Absence of donor (product)-specific anti-HLA antibodies (DSA).
- Adequate hematological, renal and liver function.
Exclusion Criteria:
- Current or history of central nervous system (CNS) lymphoma.
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Radiation therapy within 2 weeks prior to ALLO-647.
- Prior irradiation to >25% of the bone marrow.
- Donor lymphocyte infusion (DLI) within 30 days prior to ALLO-647.
- Patients unwilling to participate in an extended safety monitoring period
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416984
Contacts
| Contact: Allogene | 415-604-5696 | clinicaltrials@allogene.com |
Locations
Show 18 study locations
Sponsors and Collaborators
Allogene Therapeutics
| Responsible Party: | Allogene Therapeutics |
| ClinicalTrials.gov Identifier: | NCT04416984 |
| Other Study ID Numbers: |
ALLO-501A-201 |
| First Posted: | June 4, 2020 Key Record Dates |
| Last Update Posted: | April 8, 2022 |
| Last Verified: | March 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Allogene Therapeutics:
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CAR T Cell Therapy Allogeneic Cell Therapy Cellular Immuno-therapy AlloCAR T |
ALLO-501A ALLO-647 LBCL Lymphoma Large B-Cell Lymphoma |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide |
Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |