The goal of this clinical trial is to learn more about the safety and effectiveness of investigational drug bb2121 in combination with lenalidomide maintenance when given to participants with relapsed and refractory or high-risk multiple myeloma.
This trial is currently open and accepting patients.
This trial is organized into five main groups, or cohorts. Depending on when their myeloma was diagnosed, and the type and quantity of treatment previously received, participants will be assigned to one of the cohorts. Cohorts 1 and 3 are accepting patients.
Participants in all cohorts are planned to receive bb2121 alone or bb2121 in combination with lenalidomide. The study can be broken down into a few different parts.
Before bb2121 administration - During this part of the trial, participants will be screened for eligibility, undergo a collection of their T cells (leukapheresis) to make into investigational drug bb2121 and undergo other evaluations before the treatment part. Depending on the cohort they are placed in, participants may receive Lenalidomide or another approved treatment as anti-myeloma therapy while waiting for their T cells to be processed.
bb2121 administration - During this part of the trial, participants will receive lymphodepleting chemotherapy and investigational drug bb2121. The lymphodepleting chemotherapy is used to remove some immune cells, making space for the investigational bb2121 T cells to grow in the body, and to increase the chances of the body’s ability to accept the investigational bb2121 T cells. When receiving investigational drug bb2121, participants will be hospitalized for approximately 14 days so that the study doctors can monitor closely for side effects.
After bb2121 administration - Once discharged from the hospital, participants will need to stay within a 30 minute drive from the treating hospital and have a dedicated caregiver staying with them for the remainder of the 30 days following investigational drug bb2121 treatment. Participants will need to visit the study site for follow-up monthly for the first 6 months, then every 3 months for the first two years. The study doctor may prescribe a maintenance anti-myeloma therapy Lenalidomide during this time.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Additional eligibility criteria apply and can be explained by the study doctor.
Phase 2
Enrollment: 265 patients (estimated)
View MoreRead the latest news and updates on this trial.
December 05, 2020
Patients with heavily pretreated multiple myeloma maintained durable responses with the chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel (ide-cel; bb2121) in updated findings presented from the phase 1 CRB-401 trial (NCT02658929).
June 01, 2018
Celgene Corporation and bluebird bio, Inc. today announced updated results from the ongoing CRB-401 phase I clinical study of bb2121, an investigational anti-B-cell maturation antigen (BCMA) CAR T cell therapy, in 43 patients with late-stage relapsed/refractory multiple myeloma.
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St. Louis, MO
Omaha, NE
Hackensack, NJ
New York, NY
Charlotte, NC
Nashville, TN
Dallas, TX
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