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CAR T-cell Therapy

CAR T Cell Therapy for Large B-Cell Lymphoma (ALPHA2 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Allogene Therapeutics

Eligibility Criteria Checklist

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

Must have

ECOG performance status 0 or 1

Relapsed or refractory disease after at least 2 lines of chemotherapy

Must not have

Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647

Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new immunotherapy treatment for adults with lymphoma that has not responded to other treatments.

Who is the study for?

Adults with relapsed or refractory large B-cell lymphoma who have tried at least two chemotherapy treatments can join. They should be relatively healthy (ECOG status 0 or 1), not have had certain recent treatments like radiation, and must not have active infections or other cancers treated in the last three years.

What is being tested?

The ALPHA-2 study is testing ALLO-501A CAR T cells after a prep treatment with fludarabine, cyclophosphamide, and ALLO-647. The goal is to see if this new therapy is safe and effective for patients whose lymphoma has come back or hasn't responded to previous treatments.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells while targeting cancer cells, as well as those commonly associated with chemotherapy such as fatigue, nausea, low blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My condition did not improve after 2 different chemotherapy treatments.

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My last relapse was diagnosed as a specific type of lymphoma.

Exclusion Criteria

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

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I haven't had any cancer treatments in the last 2 weeks.

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I had a stem cell transplant using my own cells within the last 6 months.

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More than a quarter of my bone marrow has been exposed to radiation.

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I do not have an active infection needing treatment.

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I have not had radiation therapy in the last 2 weeks.

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My bone marrow is less active than usual for my age.

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My cancer has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicities (DLT) at increasing doses of ALLO-501A

Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501A

Phase 2: Overall Response Rate (ORR) assessed per Independent Review Committee (IRC)

Secondary study objectives

Phase 1a, 1b, and 2: AEs as characterized by preferred term, frequency, severity, timing, seriousness, and relationship to ALLO-647

Phase 1a, 1b, and 2: Adverse Events (AEs) as characterized by preferred term, frequency, severity timing, seriousness, and relationship to ALLO-501A

Phase 1a, 1b, and 2: Best overall response (CR, PR, SD, PD) assessed per IRC (Phase 2 only) and per investigator

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