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CAR T-cell Therapy

bb2121 for Multiple Myeloma (KarMMa-4 Trial)

Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years after last subject bb2121 infused
Awards & highlights

KarMMa-4 Trial Summary

This trial is for a new cancer treatment for patients with multiple myeloma who have received 3 cycles of standard induction therapy. The treatment involves leukapheresis to collect autologous mononuclear cells, which are then manufactured into the drug product bb2121. Subjects receive bb2121 infusion after fourth cycle of induction therapy and lymphodepleting therapy. Maintenance therapy is recommended for all subjects who have received bb2121 infusion.

Eligible Conditions
  • Multiple Myeloma

KarMMa-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years after last subject bb2121 infused
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years after last subject bb2121 infused for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events (AEs)
Dose-limiting toxicity (DLT) rates
Secondary outcome measures
Duration of Response (DoR)
Feasibility of initiating maintenance
Overall Response Rate (ORR)
+8 more

KarMMa-4 Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment4 Interventions
bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 800 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy with a planned starting dose of 450 x 10^6 CAR+ T cells. Lenalidomide maintenance therapy is recommended for all patients and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idecabtagene vicleucel
FDA approved
Fludarabine
2012
Completed Phase 3
~1080
Lenalidomide
2005
Completed Phase 2
~1070
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
642 Previous Clinical Trials
130,540 Total Patients Enrolled
144 Trials studying Multiple Myeloma
42,086 Patients Enrolled for Multiple Myeloma
Suresh Shelat, MD, PhDStudy DirectorCelgene/BMS
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,519 Previous Clinical Trials
3,372,176 Total Patients Enrolled
74 Trials studying Multiple Myeloma
26,057 Patients Enrolled for Multiple Myeloma
~3 spots leftby Jun 2025
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