Study of bb21217 in Multiple Myeloma

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT03274219

Run by

2seventy bio

People needed

72

Starts

2017-08-16

Expected to finish

2022-12-02

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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 may not qualify 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

Where it is running

• UCSF Medical Center at Parnassus — San Francisco, California, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Insitute, Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• John Theurer Cancer Center at Hackensack UMC — Hackensack, New Jersey, United States
• Mount Sinai Medical Center — New York, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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