Study on the Safety and Effectiveness of ALLO-501A CAR T Cells for Adults with Relapsed or Hard-to-Treat Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, and Small Lymphocytic Lymphoma
Sponsor: Allogene Therapeutics
ClinicalTrials ID:NCT04416984
This clinical trial is testing a new treatment called ALLO-501A, which uses modified immune cells to target cancer in adults with certain types of lymphoma and leukemia that have not responded to previous treatments.
Patient Parameters
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Program Overview
The ALPHA2 study is a Phase 1/2 trial that aims to evaluate the safety and effectiveness of ALLO-501A, a type of CAR T-cell therapy, in adults with relapsed or refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also look at how the treatment behaves in the body after patients receive a preparatory treatment with fludarabine, cyclophosphamide, and ALLO-647.
Eligibility Criteria
Inclusion Criteria
For participants with Large B-Cell Lymphoma (LBCL):
- Confirmed diagnosis of relapsed or hard-to-treat large B-cell lymphoma.
- At least one tumor that can be measured at the time of joining the study.
- Cancer has returned or not responded after at least two rounds of chemotherapy.
- No significant antibodies against the treatment product (only for Phase 2).
For participants with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL):
- Diagnosis of CLL or SLL.
- Cancer has returned or not responded to treatment.
- Cancer has not responded to BTK inhibitor therapy and is considered high-risk.
- Cancer has not responded after two or more treatments, including BTK inhibitors and BCL-2 inhibitors like venetoclax.
- At least one tumor that can be measured at the time of joining the study.
For all participants:
- Must be 18 years or older.
- Must be in good general health with an ECOG performance status of 0 or 1.
- Must have adequate blood, kidney, and liver function.
Exclusion Criteria
- Active cancer involvement in the brain or spinal cord.
- Current thyroid disorder, unless it is hypothyroidism controlled with medication.
- Any other active cancers that needed treatment in the last 3 years.
- Radiation therapy within 2 weeks before receiving ALLO-647.
- Previous radiation to more than 25% of the bone marrow.
- Low bone marrow cell count for age, based on a biopsy at screening (only for Phase 2).
- Stem cell transplant within the last 6 months.
- Anti-cancer treatment within 2 weeks before receiving ALLO-647.
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