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Recruiting NCT06006741

Universal CAR-T Cells Targeting Multiple Myeloma

Conditions: Multiple Myeloma in Remission

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 20
Sponsor: Shenzhen Geno-Immune Medical Institute

Location: Shenzhen Geno-Immune Medical Institute Shenzhen Guangdong

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06006741). StuddyBuddy aggregates publicly available trial information.