Universal CAR-T Cells Targeting Multiple Myeloma
Recruiting now · Phase 1
Conditions studied: Multiple Myeloma in Remission
In brief
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.
Key facts
- Study ID
- NCT06006741
- Run by
- Shenzhen Geno-Immune Medical Institute
- People needed
- 20
- Starts
- 2023-10-31
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Shenzhen Geno-Immune Medical Institute — Shenzhen, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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