Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2017-08-16
2022-12-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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bb21217 Experimental Arm
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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2seventy bio
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Truppel-Hartmann, MD
Role: STUDY_DIRECTOR
Genetix Biotherapeutics Inc.
Locations
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UCSF Medical Center at Parnassus
San Francisco, California, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Insitute, Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Mount Sinai Medical Center
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Countries
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References
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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.
Other Identifiers
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CRB-402
Identifier Type: -
Identifier Source: org_study_id
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