Multiple Myeloma Clinical Trial

BCMA-directed CAR-T Cell Therapy in Adult Patients With Multiple Myeloma

Summary

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

View Full Description

Full Description

This is 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. In the dose escalation part (Part A) of the study, the anti-BCMA CAR-T cell therapy will be studied in adult multiple myeloma (MM) subjects who are relapsed and/or refractory. In the dose evaluation part (Part B) of the study, the anti-BCMA CAR-T cell therapy will be studied in newly diagnosed adult subject with MM.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 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 is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

96

Study ID:

NCT04318327

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 11 Locations for this study

See Locations Near You

University of Chicago Medical Center Hematology and Oncology
Chicago Illinois, 60637, United States
University of Kansas Cancer Center .
Westwood Kansas, 66205, United States
Beth Israel Deaconess Medical Cente KS121
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute Main Centre
Boston Massachusetts, 02215, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Novartis Investigative Site
Prahran Victoria, 3181, Australia
Novartis Investigative Site
Camperdown , NSW, Australia
Novartis Investigative Site
Haifa , 31096, Israel
Novartis Investigative Site
Ramat Gan , 52621, Israel
Novartis Investigative Site
Tel Aviv , 64239, Israel
Novartis Investigative Site
Singapore , 11922, Singapore
Novartis Investigative Site
Singapore , 16960, Singapore

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

96

Study ID:

NCT04318327

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.