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CAR T-cell Therapy

CAR T Cell Therapy for Multiple Myeloma (KarMMa Trial)

Phase 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
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Must be refractory to the last treatment regimen.
Must not have
Ongoing treatment with chronic immunosuppressants
Subjects with known central nervous system involvement with myeloma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of 24 months post-bb2121 infusion
Awards & highlights

Summary

This trial is testing a new cancer treatment involving CAR T cells. Lymphodepleting therapy will be used prior to infusion of the CAR T cells.

Who is the study for?
This trial is for adults over 18 with multiple myeloma that's come back or hasn't responded to treatment. They must have tried at least three different treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Participants need measurable levels of the disease in their blood or urine and should be fairly healthy otherwise (ECOG status 0 or 1). Pregnant women, those with CNS involvement by myeloma, certain infections like HIV/HBV/HCV, severe heart conditions, or previous gene/cellular therapies can't join.Check my eligibility
What is being tested?
The study tests bb2121—a CAR T-cell therapy—on people whose multiple myeloma has relapsed or is refractory. Patients will undergo a leukapheresis procedure to collect cells needed to create bb2121 which are then infused back after receiving drugs (fludarabine and cyclophosphamide) that prepare their immune system.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever and chills; low blood cell counts leading to increased infection risk; fatigue; nausea; headaches; shortness of breath; potential allergic reactions to the drug components used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You did not respond well to the last treatment you received.
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You have been diagnosed with multiple myeloma and it is written in your medical records.
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You must have tried at least 3 different treatments for multiple myeloma. If you had a stem cell transplant and/or maintenance therapy after your initial treatment, it still counts as one regimen.
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You must have tried at least two rounds of treatment for each plan, unless your condition got worse as the best response to the plan.
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You must have already taken certain types of medications called proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.
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You are in good enough health to carry out your usual activities without limitations (ECOG performance status 0 or 1).
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You must have recovered from any side effects of previous treatments, except for hair loss and mild nerve problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You are currently taking medicine that weakens your immune system.
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You have myeloma that has spread to your central nervous system.
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You have a history of important brain or spinal cord problems.
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You have had a stem cell transplant or gene therapy for cancer in the past.
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You currently have or have had plasma cell leukemia.
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You have a type of plasma cell cancer that is not easily measurable.
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Your organs don't work well enough.
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You have had serious heart problems like severe heart failure, stroke, heart attack, or dangerous heart rhythm issues in the past 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of 24 months post-bb2121 infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 24 months post-bb2121 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Adverse Events (AEs)
Complete Response (CR) Rate
Duration of Response
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Administration of bb2121Experimental Treatment1 Intervention
bb2121 autologous CAR T cells will be infused at a dose ranging from 15 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bb2121
2017
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
643 Previous Clinical Trials
129,963 Total Patients Enrolled
144 Trials studying Multiple Myeloma
41,484 Patients Enrolled for Multiple Myeloma
Kristen HegeStudy DirectorCelgene
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Multiple Myeloma
50 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,536 Previous Clinical Trials
3,375,658 Total Patients Enrolled
74 Trials studying Multiple Myeloma
25,455 Patients Enrolled for Multiple Myeloma

Media Library

bb2121 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03361748 — Phase 2
Multiple Myeloma Research Study Groups: Administration of bb2121
Multiple Myeloma Clinical Trial 2023: bb2121 Highlights & Side Effects. Trial Name: NCT03361748 — Phase 2
bb2121 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03361748 — Phase 2
~20 spots leftby Jul 2025