Status:
TERMINATED
BCMA-directed CAR-T Cell Therapy in Adult Patients With Multiple Myeloma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
This was a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a novel B-cell Maturation Antigen (BCMA)-specif...
Detailed Description
This was a phase I, open label study to characterize the safety and tolerability of a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR) manufactured with a new process. I...
Eligibility Criteria
Inclusion
- Part A: Subjects with MM who are relapsed and/or refractory to at least 2 prior treatment regimens, including an IMiD (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g. daratumumab), if available, and have documented evidence of disease progression (IMWG criteria)
- Part A: ECOG performance status that is either 0 or 1 at screening
- Part B: Subjects with newly diagnosed multiple myeloma (NDMM) who have received a minimum of 4 and up to 6 cycles of standard induction therapy with VRd, D-VRd, or D-Rd, and have achieved a response of PR or better. One cycle of CyBorDex is allowed prior to induction.
- Part B: ECOG performance status that is either 0,1 or 2 at screening
- Measurable disease as defined by the protocol
- Adequate hematological values
- Must have a leukapheresis material of non-mobilized cells accepted for manufacturing
Exclusion
- Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. Patients who have received prior BCMA-directed bi-specific antibodies or antibody-drug conjugates (ADC) are not excluded.
- Autologous HSCT within 6 weeks prior to enrollment or any prior history of allogeneic hematopoietic stem cell transplant (HSCT)
- Chemotherapy or any concomitant anti-cancer therapies (other than protocol prescribed lymphodepletion (LD) chemotherapy) within 2 weeks prior to apheresis
- Treatment with small molecule targeted antineoplastics within 2 weeks of apheresis collection or 5 half-lives whichever is shorter
- Have received antibodies or immunotherapies (other than daratumumab) within 4 weeks prior to apheresis collection. Daratumumab within 3 weeks prior to apheresis collection.
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04318327
Start Date
July 23 2020
End Date
April 29 2025
Last Update
May 20 2025
Active Locations (9)
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1
Uni of Chi Medi Ctr Hema and Onco
Chicago, Illinois, United States, 60637
2
Beth Israel Deaconess Medical Cente
Boston, Massachusetts, United States, 02215
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226