Study of bb21217 in Multiple Myeloma



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:August 16, 2017
End Date:June 2020
Contact:bluebird bio
Email:clinicaltrials@bluebirdbio.com
Phone:339-499-9300

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

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).

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.

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 including proteasome inhibitor (e.g., bortezomib or
carfilzomib) and immunomodulatory therapy (IMiD; e.g., lenalidomide or pomalidomide),
or have double refractory disease to a proteasome inhibitor and IMiD, defined as
progression on or within 60 days of treatment with these agents.

- 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.

- Subjects with a history of stroke, unstable angina, myocardial infarction, or
ventricular arrhythmia requiring medication or mechanical control

- Pregnant or lactating women
We found this trial at
11
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Phone: 615-339-4214
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-9920
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-795-1180
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Phone: 212-241-8615
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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1365 Clifton Road
Atlanta, Georgia 30322
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Atlanta, GA
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Phone: 617-726-0711
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4774
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Hackensack, New Jersey 07601
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Hackensack, NJ
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 855-776-0015
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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San Francisco, California 94143
Phone: 415-514-8133
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San Francisco, CA
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Tampa, Florida 33612
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Tampa, FL
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