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Study of bb21217 in Multiple Myeloma

Sponsor
bluebird bio (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03274219
Collaborator
(none)
72
Enrollment
11
Locations
1
Arm
97.5
Anticipated Duration (Months)
6.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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
  • 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
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 :
Aug 16, 2017
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 UCSF Medical Center at Parnassus San Francisco California United States 94143
2 H. Lee Moffitt Cancer Center Tampa Florida United States 33612
3 Winship Cancer Insitute, Emory University Atlanta Georgia United States 30322
4 University of Chicago Chicago Illinois United States 60637
5 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02144
6 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
7 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
8 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
9 John Theurer Cancer Center at Hackensack UMC Hackensack New Jersey United States 07601
10 Mount Sinai Medical Center New York New York United States 10029
11 Sarah Cannon Research Institute Nashville Tennessee United States 37203

Sponsors and Collaborators

  • bluebird bio

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
bluebird bio
ClinicalTrials.gov Identifier:
NCT03274219
Other Study ID Numbers:
  • CRB-402
First Posted:
Sep 6, 2017
Last Update Posted:
Mar 18, 2021
Last Verified:
Mar 1, 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

Study Results

No Results Posted as of Mar 18, 2021