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

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CAR T cells
Sponsored by
Shenzhen Geno-Immune Medical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, chimeric antigen receptor, BCMA, CD38, CD56, CD138

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shenzhen Geno-immune Medical InstituteRecruiting
  • The First People's Hospital of YunnanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

CAR T cells to treat MM

Outcomes

Primary Outcome Measures

Percentage of patients with treatment related adverse effect
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
by measuring CAR copies in the body
Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM
by physical examination of tumor burden

Full Information

First Posted
August 27, 2017
Last Updated
September 18, 2019
Sponsor
Shenzhen Geno-Immune Medical Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03271632
Brief Title
Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma
Official Title
Multiple Antigen-specific CAR T Cells For the Treatment of Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen Geno-Immune Medical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, chimeric antigen receptor, BCMA, CD38, CD56, CD138

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
CAR T cells to treat MM
Intervention Type
Biological
Intervention Name(s)
CAR T cells
Intervention Description
Infusion of multi-CAR T cells
Primary Outcome Measure Information:
Title
Percentage of patients with treatment related adverse effect
Description
percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Anti-tumor activity of fourth generation multiple CAR-T cells after infusion
Description
by measuring CAR copies in the body
Time Frame
1 year
Title
Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM
Description
by physical examination of tumor burden
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lung-Ji Chang
Phone
86-075586725195
Email
c@szgimi.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lung-Ji Chang
Organizational Affiliation
Shenzhen Geno-Immune Medical Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen Geno-immune Medical Institute
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lung-Ji Chang, PhD
Phone
86-075586725195
Email
c@szgimi.org
Facility Name
The First People's Hospital of Yunnan
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun Lai, Master
Phone
13577096609
Email
1729112214@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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