ALLO-501 CAR T Cells for Lymphoma
(ALPHA Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Allogene Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Eligibility Criteria

Adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma can join this trial. They must have tried at least two chemotherapy treatments, have one measurable lesion, be in good physical condition (ECOG score of 0 or 1), and their major organs need to function well. People with CNS lymphoma, recent stem cell transplants, prior CD19 therapy, ongoing immunosuppressants, active GvHD, severe immunodeficiency disorders or uncontrolled thyroid disease cannot participate.

Inclusion Criteria

My blood, kidney, liver, lung, and heart functions are all within normal ranges.

At least 1 measurable lesion at time of screening

My condition did not improve after two chemotherapy treatments.

+6 more

Exclusion Criteria

I have previously received treatments like CAR-T cell therapy.

Patients unwilling to participate in an extended safety monitoring period

I am currently taking medication to suppress my immune system.

+7 more

Participant Groups

The ALPHA study is testing the safety and effectiveness of ALLO-501 Anti-CD19 Allogeneic CAR T Cells after a preparatory treatment with fludarabine, cyclophosphamide, and ALLO-647. The goal is to see how these cells work as a treatment for certain types of lymphoma that haven't responded to other therapies.

1Treatment groups

Experimental Treatment

Group I: ALLO-647, ALLO-501Experimental Treatment4 Interventions