Ide-cel Combination Therapy for Multiple Myeloma (KarMMa-7 Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Celgene

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a global, open-label, multi-arm, multi-cohort, multi-center, phase 1/2 study to determine the safety, tolerability, efficacy, PK of bb2121 in combination with other therapies in adult subjects with R/RMM. The following combinations will be * Arm A will test bb2121 in combination with CC-220 (± low-dose dexamethasone) * Arm B will test bb2121 in combination with BMS-986405 (JSMD194) Combination agents being tested may be administered before, concurrently with and/or following (ie, maintenance) bb2121 infusion. The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms.

Eligibility Criteria

This trial is for adults with relapsed or refractory multiple myeloma (R/RMM) who've had at least one prior treatment. They should have shown some response to previous treatments and currently show disease progression. Good physical condition (ECOG 0-1) is required, but those with certain blood conditions, severe liver issues, recent bleeding events or specific past treatments like gene therapy are excluded.

Inclusion Criteria

I have been diagnosed with multiple myeloma and it can be measured.

I am fully active or can carry out light work.

I've been treated with specific cancer drugs for at least 2 cycles.

Exclusion Criteria

I have a specific blood cancer type, not the common multiple myeloma.

If you have any of the following issues in your blood, kidney function, liver function, or clotting, or if you have certain lung or previous treatment problems, you may not be able to participate in this study.

Treatment Details

The study tests bb2121 combined with other drugs in two arms: Arm A pairs it with CC-220 (with/without dexamethasone), while Arm B uses BMS-986405. It's a phase 1/2 trial aiming to find the right doses and expand testing based on safety and effectiveness results from earlier phases.

2Treatment groups

Experimental Treatment

Group I: Arm B- bb2121 in combination with BMS-986405 (JSMD194)Experimental Treatment2 Interventions

* bb2121 will be administered at a target dose of 450 x 10\^6 CAR+T cells. The combination agent will be administered during Month 1 starting from the day of bb2121 infusion * Enrollment is closed for this Arm

Group II: Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone)Experimental Treatment2 Interventions

bb2121 will be administered at a target dose of 450 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules, depending on dose limiting toxicity (DLT) evaluation.