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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03271632
• Other study ID #: GIMI-IRB-17013
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 15, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: Shenzhen Geno-Immune Medical Institute
• Contact: Lung-Ji Chang
• Phone: 86-075586725195
• Email: c[@]szgimi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• CAR T cells
Infusion of multi-CAR T cells

Locations

Country	Name	City	State
China	The First People's Hospital of Yunnan	Kunming	Yunnan
China	Shenzhen Geno-immune Medical Institute	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Geno-Immune Medical Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	Anti-tumor activity of fourth generation multiple CAR-T cells after infusion	by measuring CAR copies in the body	1 year
Secondary	Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM	by physical examination of tumor burden	1 year