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NCT06006741

Universal CAR-T Cells Targeting Multiple Myeloma

RecruitingPHASE1

Study 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 function of the universal CAR T cells in the body.

At a glance

Conditions
Multiple Myeloma in Remission
Interventions
MM-specific universal CAR T cells
Lead sponsor
Shenzhen Geno-Immune Medical Institute
Target enrollment
20 participants
Age
18 Years80 Years
Sex
ALL
Locations
Shenzhen Geno-Immune Medical Institute
Registry
View on ClinicalTrials.gov ↗

Eligibility criteria

Inclusion Criteria: 1. Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT). 2. Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens. 3. High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases. 4. Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year). 5. Relapsed after prior autologous or allogenic SCT with residual disease after at least 1 prior therapy and not eligible for allogeneic SCT. 6. Residual disease after primary therapy and not eligible for ASCT 7. Expected survival \> 12 weeks• Creatinine \< 2.5 mg/dl• ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal 8. Bilirubin \< 2.0 mg/dl 9. Any relapse after prior SCT is eligible regardless of other prior therapy 10. Adequate venous access for apheresis, and no other contraindications for leukapheresis 11. Voluntary informed consent is signed Exclusion Criteria: 1. Pregnant or lactating women 2. Uncontrolled active infection 3. Active hepatitis B or hepatitis C infection 4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. 5. Previous related CAR-T cell therapy 6. Any uncontrolled active medical disorder that would preclude participation 7. HIV infection