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CAR T-cell Therapy

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

Phase 1

Waitlist Available

Research Sponsored by Allogene Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapse or refractory disease after at least 2 lines of chemotherapy

Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.

Must not have

Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy

On-going treatment with immunosuppressive agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 33 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for people with lymphoma who haven't responded to other treatments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the infusion process itself such as fever and chills; low blood counts leading to increased risk of infection; fatigue; liver dysfunction; neurological events like confusion or seizures; and potential immune system complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition did not improve after two chemotherapy treatments.

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I have been diagnosed with Large B-cell Lymphoma or Follicular Lymphoma.

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I am fully active or can carry out light work.

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I am fully active or can carry out light work.

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I have been diagnosed with Large B-cell Lymphoma or Follicular Lymphoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently taking medication to suppress my immune system.

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I have a serious brain or nerve condition affecting my daily life.

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I have or had brain lymphoma.

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I had a stem cell transplant within the required time frame before starting ALLO-647.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 33 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~33 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 33 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501

Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501