RecruitingPhase 1Phase 2NCT06429150
Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma
Frontline Management of High-Risk Multiple Myeloma or Plasmacytoma With BCMA and GPRC5D Combination CAR-T Cell Therapy
Sponsor
Shenzhen Geno-Immune Medical Institute
Enrollment
20 participants
Start Date
May 11, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria6
- Male and female subjects with multiple myeloma or plasmacytoma
- Strictly complete remission (sCR) is a treatment goal
- Expected survival \> 12 weeks
- After prior auto-SCT is eligible regardless of other prior therapies
- Adequate venous access for apheresis, and no other contraindications for leukapheresis
- Voluntary informed consent is given and commitment to continued follow-up
Exclusion Criteria5
- Pregnant or lactating women
- Uncontrolled active infection
- Active HIV, hepatitis B or hepatitis C infection
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Any medical conditions that may preclude participation
Interventions
BIOLOGICALCAR-T cells
Infusion of multi-CAR-T cells
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06429150
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