Study of bb21217 in Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT03274219
• Recruitment Status: Active, not recruiting
• First Posted: September 6, 2017
• Last Update Posted: March 18, 2021
• Sponsor: bluebird bio
• Information provided by (Responsible Party): bluebird bio

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Biological: bb21217	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study of bb21217, an Anti-BCMA CAR T Cell Drug Product, in Relapsed and/or Refractory Multiple Myeloma
• Actual Study Start Date: August 16, 2017
• Estimated Primary Completion Date: October 2025
• Estimated Study Completion Date: October 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: bb21217 Experimental Arm	Biological: bb21217; autologous T cells transduced ex-vivo with anti-BCMA CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA, suspended in cryopreservative solution

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events (AEs), DLTs, and changes in laboratory results [ Time Frame: Day 1 through Month 60 ]
   Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs)

Secondary Outcome Measures :

1. Disease-specific response criteria [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

UCSF Medical Center at Parnassus

San Francisco, California, United States, 94143

United States, Florida

H. Lee Moffitt Cancer Center

Tampa, Florida, United States, 33612

United States, Georgia

Winship Cancer Insitute, Emory University

Atlanta, Georgia, United States, 30322

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02144

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Minnesota

Mayo Clinic Cancer Center

Rochester, Minnesota, United States, 55905

United States, New Jersey

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, United States, 07601

United States, New York

Mount Sinai Medical Center

New York, New York, United States, 10029

United States, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

bluebird bio

Investigators

• Study Director: Anna Truppel-Hartmann, MD; bluebird bio

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Madduri D, Parekh S, Campbell TB, Neumann F, Petrocca F, Jagannath S. Anti-BCMA CAR T administration in a relapsed and refractory multiple myeloma patient after COVID-19 infection: a case report. J Med Case Rep. 2021 Feb 19;15(1):90. doi: 10.1186/s13256-020-02598-0.

• Responsible Party: bluebird bio
• ClinicalTrials.gov Identifier: NCT03274219
• Other Study ID Numbers: CRB-402
• First Posted: September 6, 2017
• Last Update Posted: March 18, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases