Study of bb21217 in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274219
• Other study ID #: CRB-402
• Status: Completed
• Phase: Phase 1
• Start date: August 16, 2017
• Est. completion date: December 2, 2022

Study information

• Verified date: April 2022
• Source: 2seventy bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
2seventy bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs), DLTs, and changes in laboratory results	Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs)	Day 1 through Month 60
Secondary	Disease-specific response criteria	• 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	Month 1 through Month 60