Clinical trial NCT03271632: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: multiple myeloma
chimeric antigen receptor
BCMA
CD38
CD56
CD138
Lead sponsor: Shenzhen Geno-Immune Medical Institute
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of patients with treatment related adverse effect
timeFrame: 1 month
Secondary outcomes:
measure: Anti-tumor activity of fourth generation multiple CAR-T cells after infusion
timeFrame: 1 year
measure: Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Geno-immune Medical Institute
state: Guangdong
city: Kunming
country: China
facility: The First People's Hospital of Yunnan
state: Yunnan
Study officials:
affiliation: Shenzhen Geno-Immune Medical Institute
name: Lung-Ji Chang
role: PRINCIPAL_INVESTIGATOR
References: