A Study of Anti-BCMA CAR-T Therapy in Newly Diagnosed Myeloma Patients Who Are Transplant-ineligible
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.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Newly Diagnosed. Basic parameters: 18 years — 70 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label, Single-arm Clinical Study of Anti-BCMA CAR-T Cell Therapy in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
Overview
This is a prospective study of anti-BCMA CAR-T in transplant-ineligible patients with newly diagnosed multiple myeloma.
Detailed description
After the diagnosis of multiple myeloma (MM), patients were stratified by frailty status. Frail patients received 4 cycles of VRd regimen (bortezomib, lenalidomide, and dexamethasone), while non-frail patients received 4 cycles of DVRd regimen (daratumumab, bortezomib, lenalidomide, and dexamethasone). Following induction therapy, peripheral blood lymphocytes were collected to manufacture anti-BCMA CAR-T cells. After lymphodepletion with the FC regimen (fludarabine and cyclophosphamide), patients received a single infusion of anti-BCMA CAR-T cells at a target dose of 2.0 × 10\^6 CAR-positive cells per kilogram of body weight. Peripheral blood samples were collected at regular intervals to assess treatment efficacy, safety, and CAR-T cell expansion and persistence. Patients were closely monitored for 6 months post-infusion. Thereafter, disease assessments, physical examinations, and hematologic tests were conducted every 3 months for a total follow-up duration of 2 years.
Interventions
- Biological CAR-T
The T cells are genetically modified to express a chimeric antigen receptor targeting BCMA and are infused after induction therapy at a target dose of ≥2.0×10\^6 cells/kg
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: Up to 36 months after CAR-T infusion]
- Overall Survival (OS) [Time frame: Up to 36 months after CAR-T infusion]
Secondary outcome measures (3)
- Objective Response Rate (ORR) [Time frame: Up to 36 months after CAR-T infusion]
- MRD [Time frame: Up to 36 months after CAR-T infusion]
- Adverse Events (AE) [Time frame: Up to 36 months after CAR-T infusion]
Eligibility criteria
Inclusion criteria
- Age between 18 and 70 years (inclusive);
- Estimated life expectancy of more than 12 weeks;
- Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);
- Karnofsky Performance Status (KPS) score > 50%.
- Ineligible for ASCT.
Exclusion criteria
- Pregnant or lactating women, or women planning to become pregnant within the next six months;
- Transduction efficiency of targeted lymphocytes <10%, or expansion fold <5× under CD3/CD28 co-stimulation, as determined by feasibility screening;
- History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);
- Significant dysfunction of vital organs including the heart, lungs, or brain;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07070960 · XYFY2025-KL280-01