Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma (ALPHA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03939026|
Recruitment Status : Active, not recruiting
First Posted : May 6, 2019
Last Update Posted : May 26, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Large B Cell Lymphoma Relapsed/Refractory Follicular Lymphoma||Genetic: ALLO-501 Biological: ALLO-647 Drug: Fludarabine Drug: Cyclophosphamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||August 2026|
|Experimental: ALLO-647, ALLO-501||
ALLO-501 is an allogeneic CAR T cell therapy targeting CD19
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Chemotherapy for lymphodepletion
Chemotherapy for lymphodepletion
- Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501 [ Time Frame: 28 days ]Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion
- Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501 [ 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|
- Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
- Relapse or refractory disease after at least 2 lines of chemotherapy
- At least 1 measurable lesion at time of screening.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Adequate hematological, renal, liver, pulmonary, and cardiac functions.
- Current or history of central nervous system (CNS) lymphoma.
- Clinically significant CNS dysfunction.
- ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
- Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
- Systemic anticancer therapy within 2 weeks prior to study entry.
- On-going treatment with immunosuppressive agents.
- Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
- Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
- Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
- Patients unwilling to participate in an extended safety monitoring period
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): NCT03939026
|United States, Arizona|
|Banner MD Anderson Cancer Center|
|Gilbert, Arizona, United States, 85234|
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|Stanford, California, United States, 94305|
|United States, Colorado|
|Colorado Blood Cancer Institute|
|Denver, Colorado, United States, 80218|
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Kentucky|
|Norton Cancer Institute|
|Louisville, Kentucky, United States, 40207|
|United States, Texas|
|St. Davids South Austin Medical Center|
|Austin, Texas, United States, 78704|
|Houston, Texas, United States, 77030|
|Responsible Party:||Allogene Therapeutics|
|Other Study ID Numbers:||
|First Posted:||May 6, 2019 Key Record Dates|
|Last Update Posted:||May 26, 2022|
|Last Verified:||May 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Allogeneic Cell Therapy
Large B-Cell Lymphoma
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action