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

Sponsor score: 0
Inactive

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

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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