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CAR T-cell Therapy

ALLO-715 CAR T Cells for Multiple Myeloma (UNIVERSAL 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

Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (serum, urine, or free light chain [FLC]) per International Myeloma Working Group (IMWG) criteria

Eastern Cooperative Oncology Group (ECOG) 0 or 1

Must not have

Subject has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat

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

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 cancer treatment for adults with multiple myeloma who have relapsed or are resistant to other treatments.

Who is the study for?

Adults with relapsed or refractory multiple myeloma who have tried at least three prior treatments, including specific inhibitors and antibodies, can join this trial. They must be in good physical condition with no significant CNS disorders, HIV, hepatitis B or C infections, recent stem cell transplants, or conditions affecting drug absorption.

What is being tested?

The UNIVERSAL study is testing the safety and effectiveness of ALLO-715 CAR T cells alone or combined with Nirogacestat following a lymphodepletion regimen. This involves using ALLO-647 along with fludarabine and/or cyclophosphamide to prepare the body for treatment.

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related symptoms like fever or chills, blood count changes leading to increased infection risk or bleeding problems. Organ function could also be affected.

Eligibility Criteria

Inclusion Criteria

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

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My multiple myeloma has returned or didn't respond to treatment, and tests show it's still present.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I do not have conditions that affect how my body absorbs medication.

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I have not had treatments like anti-BCMA, gene therapy, or T cell therapy.

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My cancer has affected or previously affected my brain or spinal cord.

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I have a history of HIV or hepatitis B or C.

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I have or had a thyroid disorder.

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I have had a stem cell transplant using my own cells within the last 6 weeks or received a transplant from a donor.

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I cannot swallow pills.

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I am not taking any medications that affect my heart's rhythm.

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I have a serious brain or nerve condition.

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

Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-715

To assess the overall safety profile and tolerability of ALLO-647 in combination with Fludarabine and/or cyclophosphamide or ALLO-647 alone, prior to ALLO-715 to confirm the dose of ALLO-647.

To assess the overall safety profile and tolerability of nirogacestat given concomitantly with ALLO-715 following lymphodepletion with Flu/ Cy/ ALLO-647.

Secondary study objectives

Anti-tumor activity of ALLO-715

Cellular kinetics of ALLO-715

Cellular kinetics of ALLO-715 in combination with nirogacestat

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