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CAR T-cell Therapy

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

Phase 1 & 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has documented diagnosis of MM and measurable disease
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months after bb2121 infusion in the respective cohort
Awards & highlights

KarMMa-7 Trial Summary

This trial is testing the safety and efficacy of a new drug, bb2121, in combination with other therapies, in adult patients with relapsed or refractory multiple myeloma. There are three arms in the trial testing different combinations of drugs. The study will first determine the best dose of bb2121 (Phase 1), and then expand to testing the efficacy of the combinations in a larger group of patients (Phase 2).

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects aren't specified here, but generally for cancer trials like this they can include fatigue, nausea, immune system reactions, infusion-related reactions from the drug combinations being tested, as well as impacts on blood cell counts leading to increased infection risk.

KarMMa-7 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with multiple myeloma and it can be measured.
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I am fully active or can carry out light work.
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I've been treated with specific cancer drugs for at least 2 cycles.

KarMMa-7 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months after bb2121 infusion in the respective cohort
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months after bb2121 infusion in the respective cohort for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response Rate (CRR)_ Phase 2
Does Limiting Toxicity (DLT) rates _Phase 1
Secondary outcome measures
Duration of Response (DoR)
Feasibility of maintenance therapy in combination with bb2121
Incidence of Adverse Event (AEs)
+11 more

KarMMa-7 Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-220
2016
Completed Phase 2
~620

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
642 Previous Clinical Trials
130,241 Total Patients Enrolled
144 Trials studying Multiple Myeloma
41,787 Patients Enrolled for Multiple Myeloma
Gianfranco Pittari, Md, PhDStudy DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,519 Previous Clinical Trials
3,371,877 Total Patients Enrolled
74 Trials studying Multiple Myeloma
25,758 Patients Enrolled for Multiple Myeloma

Media Library

BB2121 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04855136 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone), Arm B- bb2121 in combination with BMS-986405 (JSMD194)
Multiple Myeloma Clinical Trial 2023: BB2121 Highlights & Side Effects. Trial Name: NCT04855136 — Phase 1 & 2
BB2121 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04855136 — Phase 1 & 2
~45 spots leftby Dec 2024
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