for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Nina Shah
Headshot of Nina Shah
Nina Shah



Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed/refractory multiple myeloma (MM).

Official Title

A Phase 1 Study of bb21217, an Anti-BCMA CAR T Cell Drug Product, in Relapsed and/or Refractory Multiple Myeloma


Part A of the study will be Dose Escalation followed by Part B, an expansion cohort.

Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (bb21217). Following manufacture of the drug product, subjects will receive lymphodepletion prior to bb21217 infusion. All subjects will then be followed for up to 60 months in Study CRB-402.

All subjects who complete the study, as well as those who withdraw from the study after receiving bb21217 for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo long-term follow-up in a companion study.


Multiple Myeloma, Plasma Cell Neoplasms


You can join if…

Open to people ages 18 years and up

  • ≥18 years of age at the time of signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy with previous exposure to PI, IMiDs, and a CD38 antibody. Have undergone at least 2 consecutive cycles of treatment for each therapy, unless PD was the best response to the therapy. Refractory to their last line of therapy.
  • Subjects must have measurable disease

You CAN'T join if...

  • Subjects with known central nervous system disease
  • Inadequate hepatic function
  • Inadequate renal function
  • Inadequate bone marrow function
  • Presence of active infection within 72 hours
  • Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
  • Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions
  • Known human immunodeficiency virus (HIV) positivity
  • Known hepatitis A virus (HAV), hepatitis B virus (HBV) or hepatitis C virus (HCV) positivity with evidence of ongoing infection.
  • Pregnant or lactating women
  • Previous history of an allogeneic bone marrow transplantation, treatment with any gene therapy based therapeutic for cancer, or BCMA-targeted therapy
  • Inadequate pulmonary function defined as oxygen saturation (SaO2) <92% on room air
  • Subjects who have a history of plasma cell leukemia, active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS, or clinically significant amyloidosis


  • UCSF Medical Center at Parnassus
    San Francisco California 94143 United States
  • Mayo Clinic Cancer Center
    Rochester Minnesota 55905 United States

Lead Scientist at UCSF

  • Nina Shah
    Dr. Nina Shah is a hematologist who specializes in the treatment of multiple myeloma, a type of cancer affecting the blood marrow. She treats patients at the Hematology and Blood Marrow and Transplant Clinic. Nina received a bachelor’s degree in cognitive neuroscience at Harvard University, followed by a medical degree from New York University School of Medicine.


in progress, not accepting new patients
Start Date
Completion Date
bluebird bio
Phase 1 Multiple Myeloma Research Study
Study Type
About 72 people participating
Last Updated