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

Active:	No
Cancer Type:	Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT04318327
Trial Phases:	Phase I	Protocol IDs:	CADPT07A12101 (primary) NCI-2020-06513
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT04318327

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 multiple myeloma

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.