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CAR T-cell Therapy

CART Therapy for Multiple Myeloma

Phase 1

Waitlist Available

Led By Alfred Garfall, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Subjects must be ≥ 18 years of age

High-risk FISH features in conjunction with Beta-2-microglobulin ≥ 5.5 mg/L

Must not have

Active hepatitis B, hepatitis C, or HIV infection, or other active, uncontrolled infection

Prior or active central nervous system (CNS) involvement with myeloma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment regimen that is based on an established safe treatment. The new regimen is being tested for safety and how well it works in patients with multiple myeloma who are responding to first- or second-line therapy.

Who is the study for?

This trial is for adults with high-risk multiple myeloma who have started treatment within the last year and seen some improvement but not a complete cure. They shouldn't have had stem cell transplants or certain chemotherapies, and their vital organs must be functioning well. Participants need to agree to birth control methods if applicable.

What is being tested?

The study tests a single-dose infusion of CART-BCMA alone or combined with huCART19 in patients after initial therapy success. It explores different chemotherapy regimens, combination treatments, and dosing strategies to improve outcomes for those at high risk.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, headache, nausea; organ inflammation; blood count changes; increased risk of infections due to immune suppression from lymphodepleting chemotherapy.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My test shows high-risk genetic features and high Beta-2-microglobulin levels.

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My blood has more than 20% plasma cells.

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My cancer worsened quickly after starting my first treatment.

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I meet the specific requirements for previous myeloma treatments.

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I have not had a stem cell transplant.

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My treatment for multiple myeloma has shown some positive response.

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Side effects from my previous treatments have mostly gone away.

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I can take care of myself and am up and about more than half of my waking hours.

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My initial cancer treatment did not work as expected.

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I have not had chemotherapy that kills cancer cells.

Exclusion Criteria

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

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I do not have active hepatitis B, C, HIV, or any uncontrolled infection.

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My myeloma has affected or is affecting my brain or spinal cord.

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I have severe heart issues, including recent heart attacks or unstable chest pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Adverse event reporting

Cytokine

Cellular composition of CAR T cell products

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase CExperimental Treatment1 Intervention

Single-dose infusion phase to test the safety of single-dose infusion of CART-BCMA alone (Cohort 1) and CART-BCMA + huCART19 (Cohort 2) as single-dose infusions after lymphodepleting chemotherapy with cyclophosphamide + fludarabine in patients responding to first- or second-line therapy.

Group II: Phase BExperimental Treatment1 Intervention

Randomization Phase in which patients responding to first or second-line therapy will receive either CART-BCMA alone (Cohort 1) or CART-BCMA + huCART19 (Cohort 2) as split-doses after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.

Group III: Phase A ExpansionExperimental Treatment1 Intervention

Once safety of CART-BCMA/huCART19 combination therapy is established in Phase A, an expansion of Phase A will occur in which the Phase A target population (patients with relapsed/refractory multiple myeloma responding to a standard salvage therapy regimen) will receive both CART-BCMA and huCART19. Enrollment into the Phase A Expansion may occur concurrently with Phase B once opened.

Group IV: Phase AExperimental Treatment1 Intervention

Safety Run-in to test the safety of CART-BCMA + huCART19 as split-dose infusions after lymphodepleting chemotherapy with cyclophosphamide + fludarabine in patients who have relapsed/refractory myeloma after two prior regimens but who are responding to their current therapy.

0 / 14Eligibility criteria met