Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAR-T cells.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Plasmacytoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Frontline Management of High-Risk Multiple Myeloma or Plasmacytoma With BCMA and GPRC5D Combination CAR-T Cell Therapy
Overview
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.
Detailed description
Multiple myeloma (MM) is the second most common malignant hematological cancer in the world, which begins with the malignant proliferation of plasma cells in bone marrow. It has been a difficult disease to treat, and most patients will eventually relapse, especially for those with high-risk genotypes. At present, the therapeutic drugs for MM include glucocorticoids, cytotoxic drugs, immunosuppressants, protease inhibitors, monoclonal antibodies and cell therapies. Among those, immunotherapy has been proven to be a revolutionary treatment with great potential of curing this disease. The frequently targeted MM antigens include CD38, CD138, CD19 and BCMA, and recently, GPRC5D.
BCMA, the B cell maturation antigen, also known as CD269 or TNFRSF17, is a member of tumor necrosis factor receptor superfamily, which is highly expressed on the surface of plasma cells and partially expressed on plasma cell-like dendritic cells. It has been an ideal target for MM immunotherapy.
GPRC5D, the G-protein-coupled receptor C57 subtype D and a seven-transmembrane protein, is highly expressed on the surface of plasma cells but not in other healthy cells, and thus it has become a potential target for the treatment of MM. The expression of GPRC5D is unrelated to BCMA, so the combination therapy targeting these antigens may bring a complementary and synergistic therapeutic outcome in patients.
This trial is aimed to test the safety and efficacy of combining these different CAR-T cells targeting BCMA and GPRC5D, and in combination with well-established therapeutics as a frontline treatment for the high-risk MM or plasmacytoma patients. Another goal of this study is to investigate the persistence and function of these CAR-T cells in the body.
Interventions
- Biological CAR-T cells
Infusion of multi-CAR-T cells
Primary outcome measures
- Percentage of patients with treatment related adverse effects [Time frame: 1 month]
Secondary outcome measures (2)
- Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion [Time frame: 1 year]
- Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shenzhen Geno-immune Medical Institute — Shenzhen
Identifiers
NCT: NCT06429150 · GIMI-IRB-24001