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

NCT07070960 | Not Yet Recruiting

• 1 other identifier: XYFY2025-KL280-01
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Myeloma; Newly Diagnosed

Keywords

Multiple Myeloma; transplant-ineligible; CAR-T

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 36 months after CAR-T infusion

• Overall Survival (OS)

  Overall Survival (OS) is defined as the time from the date of CAR-T cell infusion to death from any cause. Patients who are alive at the time of analysis will be censored at their last known date of follow-up.

  Up to 36 months after CAR-T infusion

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Up to 36 months after CAR-T infusion

• MRD

  Up to 36 months after CAR-T infusion

• Adverse Events (AE)

  Up to 36 months after CAR-T infusion

Study Arms (1)

CAR-T

EXPERIMENTAL

CAR-T alone

Biological: CAR-T

Interventions

CAR-T 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

CAR-T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuzhou Medical University: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kailin Xu

  The Affiliated Hospital oh Xuzhou Medical University

  STUDY CHAIR

Central Study Contacts

Kailin Xu

CONTACT

+8615162166166; lihmd@163.com

Kailin Xu

CONTACT

15162166166; lihmd@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Hematologist of The Affiliated Hospital of Xuzhou Medical University

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share