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NCT03271632

Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma

RecruitingPHASE1PHASE2

Study summary

The aim of this clinical trial is to assess the feasibility, safety and efficacy of autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.

At a glance

Conditions
Multiple Myeloma
Interventions
CAR T cells
Lead sponsor
Shenzhen Geno-Immune Medical Institute
Target enrollment
20 participants
Age
18 Years80 Years
Sex
ALL
Locations
Shenzhen Geno-immune Medical Institute
Registry
View on ClinicalTrials.gov ↗

Eligibility criteria

Inclusion Criteria: * Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT). * Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens. * MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor. * Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year). * Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT. * Residual disease after primary therapy and not eligible for ASCT * Expected survival \> 12 weeks * Creatinine \< 2.5 mg/dl * ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal * Bilirubin \< 2.0 mg/dl * Any relapse after prior SCT is eligible regardless of other prior therapy * Adequate venous access for apheresis, and no other contraindications for leukapheresis * Voluntary informed consent is given Exclusion Criteria: * Pregnant or lactating women * Uncontrolled active infection * Active hepatitis B or hepatitis C infection * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation * HIV infection