ALLO-715 CAR T Cells for Multiple Myeloma
(UNIVERSAL Trial)

Recruiting in Palo Alto (17 mi)

+11 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

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

You do not have antibodies against the donor's cells.

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

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

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Exclusion Criteria

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

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

Patients unwilling to participate in an extended safety monitoring period

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Treatment Details

Interventions

ALLO-715 (CAR T-cell Therapy)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ALLO-647, ALLO-715, NirogacestatExperimental Treatment5 Interventions