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

Sponsor

Shenzhen Geno-Immune Medical Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT03271632

Collaborator

(none)

Enrollment

Locations

Arm

41.6

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Biological: CAR T cells	Phase 1/Phase 2

Detailed Description

Multiple myeloma (MM) is a malignancy of plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantation (SCT). This trial is to test the safety and efficacy of T cells genetically modified to specifically target several MM surface antigens, including BCMA, CD38, CD56, CD138 or alternative MM surface antigens, based on a multi-CAR T cell immunotherapy approach. Another goal of the study is to investigate the persistence and function of CAR T cells in the body after CAR T cell infusion.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multiple Antigen-specific CAR T Cells For the Treatment of Multiple Myeloma

Actual Study Start Date :

Jul 15, 2017

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm CAR T cells to treat MM	Biological: CAR T cells Infusion of multi-CAR T cells

Arm

Intervention/Treatment

Experimental: Single arm

CAR T cells to treat MM

Biological: CAR T cells

Infusion of multi-CAR T cells

Outcome Measures

Primary Outcome Measures

Percentage of patients with treatment related adverse effect [1 month]
percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests.

Secondary Outcome Measures

Anti-tumor activity of fourth generation multiple CAR-T cells after infusion [1 year]
by measuring CAR copies in the body
Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM [1 year]
by physical examination of tumor burden

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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