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

• ClinicalTrials.gov Identifier: NCT03271632
• Recruitment Status: Unknown
• First Posted: September 5, 2017
• Last Update Posted: September 19, 2019
• Sponsor: Shenzhen Geno-Immune Medical Institute
• Information provided by (Responsible Party): Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

Tracking Information

• First Submitted Date: August 27, 2017
• First Posted Date: September 5, 2017
• Last Update Posted Date: September 19, 2019
• Actual Study Start Date: July 15, 2017
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 22, 2017)

Percentage of patients with treatment related adverse effect [ Time Frame: 1 month ]

percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests.

Original Primary Outcome Measures (submitted: August 31, 2017)

percentage of patients with treatment related adverse effect [ Time Frame: 1 month ]

percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical labs and so on.

Current Secondary Outcome Measures (submitted: January 31, 2018)

• Anti-tumor activity of fourth generation multiple CAR-T cells after infusion [ Time Frame: 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 [ Time Frame: 1 year ]
  by physical examination of tumor burden

Original Secondary Outcome Measures (submitted: August 31, 2017)

Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory MM [ Time Frame: 1 year ]

scale of CAR copies and tumor burden

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma

Intervention

Biological: CAR T cells

Infusion of multi-CAR T cells

Study Arms

Experimental: Single arm

CAR T cells to treat MM

Intervention: Biological: CAR T cells

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 22, 2017): 20
• Original Estimated Enrollment (submitted: August 31, 2017): 10
• Estimated Study Completion Date: December 31, 2020
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03271632
• Other Study ID Numbers: GIMI-IRB-17013
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Shenzhen Geno-Immune Medical Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lung-Ji Chang; Shenzhen Geno-Immune Medical Institute

• PRS Account: Shenzhen Geno-Immune Medical Institute
• Verification Date: September 2019