BCMA-directed CAR-T Cell Therapy in Adult Patients With Multiple Myeloma
Multiple Myeloma
Plasma cell neoplasm
18 Years and older, Male and Female
CADPT07A12101 (primary)
NCI-2020-06513
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.
Eligibility
- 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
Treatment Sites in Georgia
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