A Study of Anti-BCMA CAR-T Therapy in Newly Diagnosed Myeloma Patients Who Are Transplant-ineligible

N/ANot Yet RecruitingNCT07070960

Xuzhou Medical University35 enrolled

Overview

This is a prospective study of anti-BCMA CAR-T in transplant-ineligible patients with newly diagnosed multiple myeloma.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma Newly Diagnosed

Interventions

CAR-TBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 18 and 70 years (inclusive); 2. Estimated life expectancy of more than 12 weeks; 3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies; 4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN); 5. Karnofsky Performance Status (KPS) score \> 50%. 6. Ineligible for ASCT. Exclusion Criteria: 1. Pregnant or lactating women, or women planning to become pregnant within the next six months; 2. Transduction efficiency of targeted lymphocytes \<10%, or expansion fold \<5× under CD3/CD28 co-stimulation, as determined by feasibility screening; 3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2); 4. Significant dysfunction of vital organs including the heart, lungs, or brain; 5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Progression-Free Survival (PFS) is defined as the time from the date of CAR-T cell infusion to the date of disease progression or death from any cause, whichever occurs first. Disease progression will be determined based on the International Myeloma Working Group (IMWG) criteria. Patients who have not progressed or died will be censored at the date of last follow-up.