Status:
UNKNOWN
Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 multi...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03271632
Start Date
July 15 2017
End Date
December 31 2020
Last Update
September 19 2019
Active Locations (2)
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1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
2
The First People's Hospital of Yunnan
Kunming, Yunnan, China, 650000