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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 3
~1480
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,841 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,850 Patients Enrolled for Multiple Myeloma
Suresh Shelat, MD, PhDStudy DirectorCelgene/BMS
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,508 Previous Clinical Trials
3,370,410 Total Patients Enrolled
72 Trials studying Multiple Myeloma
25,274 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are engaged in the implementation of this experiment?

"Patiens can sign up for this trial at Local Institution - 103 in Nashville, Tennessee, Local Institution - 112 in Portland, Oregon and the flagship location of Local Institutioin - 121 situated in New york City. Additionally, there are 42 other sites available to enroll patients."

Answered by AI

Does the door remain open for potential participants to join this experiment?

"The clinical trial listed on ClinicalTrials.gov does not appear to be looking for participants at the moment; it was initially posted in late May 2020 and edited last October 7th 2022. Nevertheless, there are currently 1973 other trials that welcome enrolment of new patients."

Answered by AI

What is the aggregate number of individuals participating in this clinical experiment?

"At this time, the trial is no longer recruiting participants. It was first made available on May 27th 2020 and its last update took place on October 7th 2022. If you are curious about other trials for similar treatments, there are 807 clinical studies enrolling patients with multiple myeloma and 1166 actively looking for candidates to test bb2121's efficacy."

Answered by AI

What health conditions have been addressed by bb2121?

"BB2121 is a common choice of treatment for those with chronic lymphocytic leukemia. Additionally, it may be effective against cancer in the lungs and other conditions that have not responded to ≥4 lines of therapy or two prior systemic chemotherapy regimens."

Answered by AI

Has bb2121 obtained authorization from the FDA?

"Since this is an initial clinical trial, there is limited data regarding bb2121's safety and efficacy. As such, the score for its safety was assigned a value of 1 on our scale."

Answered by AI

What are the key aims of this clinical research endeavor?

"The clinical trial sponsor, Celgene, has reported that the primary outcome they will measure over a two-year period after the last patient's infusion is dose-limiting toxicity (DLT). Secondary outcomes include overall survival (OS), pharmacokinetics - AUC and time to complete response (TCR)."

Answered by AI

Could you elucidate what other experimentation has been done in regards to bb2121?

"Currently, 1166 research projects are exploring bb2121. Out of those investigations, 217 have progressed to their third phase and 40648 medical centres worldwide are hosting trials for this medication. Notably, Philadelphia is a hub for such studies."

Answered by AI
~3 spots leftby May 2025