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

NCT ID: NCT07070960

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2028-07-31

Brief Summary

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.

Conditions

Multiple Myeloma; Newly Diagnosed

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR-T

CAR-T alone

Group Type: EXPERIMENTAL

CAR-T

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kai Lin Xu，MD

Chief Hematologist of The Affiliated Hospital of Xuzhou Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kailin Xu

Role: STUDY_CHAIR

The Affiliated Hospital oh Xuzhou Medical University

Central Contacts

Kailin Xu

Role: CONTACT

lihmd@163.com

+8615162166166

Kailin Xu

Role: CONTACT

lihmd@163.com

15162166166

Other Identifiers

XYFY2025-KL280-01

Identifier Type: -

Identifier Source: org_study_id