Status:
RECRUITING
Universal CAR-T Cells Targeting Multiple Myeloma
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
Multiple Myeloma in Remission
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and functi...
Detailed Description
Multiple myeloma (MM) is a malignancy of the plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantati...
Eligibility Criteria
Inclusion
- Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT).
- Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens.
- High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases.
- 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 with 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 signed
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 :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06006741
Start Date
October 31 2023
End Date
December 31 2026
Last Update
October 12 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shenzhen Geno-Immune Medical Institute
Shenzhen, Guangdong, China, 518000