BCMA-directed CAR-T Cell Therapy in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

Phase I, Open Label, Study of B-cell Maturation Antigen (BCMA)-Directed CAR-T Cells in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

ClinicalTrials.gov Identifier: NCT04318327

Novartis Reference Number: CADPT07A12101

Last Update: Jul 29, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is 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)-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated as a single agent in relapsed/refractory multiple myeloma

Multiple Myeloma
Phase 1
Overall status 
Start date 
Jul 23, 2020
Completion date 
Mar 20, 2025
18 Years and older (Adult, Older Adult)



Eligibility Criteria

Inclusion Criteria:

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)
Measurable disease as defined by the protocol
ECOG performance status that is either 0 or 1 at screening
Adequate hematological values
Must have a leukapheresis material of non-mobilized cells accepted for manufacturing

Exclusion Criteria:

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.

Study Locations

United States
University of Chicago Medical Center Hematology and Oncology
Chicago, 60637 - Illinois
Contact: (773-834-8980) Benjamin Derman
United States
Massachusetts General Hospital
Boston, 02114 - Massachusetts
Contact: Molly Bennett - [email protected] - Andrew Branagan
United States
Beth Israel Deaconess Medical Cente KS121
Boston, 02215 - Massachusetts
Contact: (617-667-9920) Jessica Liegel
United States
Dana-Farber Cancer Institute
Boston, 02215 - Massachusetts
Contact: Soo Y Im (617-632-4295) - [email protected] - Adam Sperling
United States
Medical College of Wisconsin
Milwaukee, 53226 - Wisconsin
Contact: Debra Pastorek (414-805-5249) - [email protected] - Saurabh Chhabra
United States


Novartis Pharmaceuticals

Have a question?

Call 1-888-669-6682 or email [email protected]