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

Phase 1

• Conditions: Multiple Myeloma
• Interventions: Biological: CAR T cells

• Registration Number: NCT03271632
• Lead Sponsor: Shenzhen Geno-Immune Medical Institute

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 Timeline

• Study Start: 2017-07-15
• Study First Submitted: 2017-08-27
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-19
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	CAR T cells	CAR T cells to treat MM

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Anti-tumor activity of fourth generation multiple CAR-T cells after infusion	1 year	by measuring CAR copies in the body

Trial Locations

Locations (2)

Shenzhen Geno-immune Medical Institute; 🇨🇳 Shenzhen, Guangdong, China

The First People's Hospital of Yunnan; 🇨🇳 Kunming, Yunnan, China