Study of bb21217 in Multiple Myeloma

Phase 1

Completed

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

≥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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
bb21217 Experimental Arm	bb21217	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs), DLTs, and changes in laboratory results	Day 1 through Month 60	Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs)

Secondary Outcome Measures

Name	Time	Method
Disease-specific response criteria	Month 1 through Month 60	• Disease-specific response criteria including, but not limited to: complete response (CR), very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma

Locations (11): Winship Cancer Insitute, Emory University
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Atlanta, Georgia, United States
Mayo Clinic Cancer Center
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Rochester, Minnesota, United States
John Theurer Cancer Center at Hackensack UMC
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Hackensack, New Jersey, United States
Mount Sinai Medical Center
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New York, New York, United States
H. Lee Moffitt Cancer Center
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Tampa, Florida, United States
University of Chicago
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Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, United States
Dana-Farber Cancer Institute
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Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States
UCSF Medical Center at Parnassus
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San Francisco, California, United States
Sarah Cannon Research Institute
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Nashville, Tennessee, United States