CAR-T Cell Therapy Combined With Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Multiple Myeloma

NCT06913179 | Not Yet Recruiting Phase 1

• 1 other identifier: XYFY2025-KL061-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Study Title CAR-T Cell Therapy Combined with Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Multiple Myeloma
2. 2.Study Objective This study aims to evaluate the safety and efficacy of CAR-T cell therapy followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed or refractory multiple myeloma. The goal is to explore a novel treatment strategy for this high-risk patient population.
3. 3.Study Design This is a single-center, open-label, single-arm clinical study. A total of 30 patients with relapsed or refractory multiple myeloma will be enrolled. All participants will receive standardized CAR-T cell therapy followed by allo-HSCT and will undergo systematic observation and follow-up to assess therapeutic efficacy and safety.
4. 4.Sample Size A total of 30 patients will be enrolled in this study.
5. 5.Eligibility Criteria (1) Inclusion Criteria Age between 18 and 70 years; Estimated life expectancy of more than 12 weeks; Diagnosis of multiple myeloma confirmed by physical examination, pathology, laboratory tests, and imaging studies; Patients with refractory multiple myeloma; Patients with relapsed multiple myeloma; ALT and AST \< 3 times the upper limit of normal; Total bilirubin \< 2.0 mg/dL; Karnofsky Performance Status (KPS) \> 50%; No severe dysfunction of major organs such as liver, kidney, or heart; Prior failure of autologous or allogeneic hematopoietic stem cell transplantation; Ineligible for stem cell transplantation or patients who declined transplantation due to other constraints; Voluntarily willing to receive CAR-T cell therapy for B cell-derived hematologic malignancies; Suitable for peripheral venous blood collection with no contraindications to leukapheresis; Able to understand and sign a written informed consent form.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  The proportion of patients achieving partial response (PR) or better according to the IMWG criteria.

  Month 6, 12, 18 and 24

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  Month 6, 12, 18 and 24

• Overall Survival (OS)

  Month 6, 12, 18 and 24

Study Arms (1)

allo-HSCT following CAR-T

EXPERIMENTAL

All enrolled patients will first receive CAR-T cell therapy. Patients who achieve complete remission (CR) following CAR-T infusion will subsequently undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) based on clinical assessment. The entire treatment process will be standardized and closely monitored, with follow-up evaluations focusing on adverse events, engraftment success, relapse risk, and overall survival.

Biological: All enrolled patients will first receive CAR-T cell therapy. Patients who achieve complete remission following CAR-T infusion will subsequently undergo allo-HSCT

Interventions

All enrolled patients will first receive CAR-T cell therapy. Patients who achieve complete remission following CAR-T infusion will subsequently undergo allo-HSCT BIOLOGICAL

All enrolled patients will first receive CAR-T cell therapy. Patients who achieve complete remission (CR) following CAR-T infusion will subsequently undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) based on clinical assessment. The entire treatment process will be standardized and closely monitored, with follow-up evaluations focusing on adverse events, engraftment success, relapse risk, and overall survival.

allo-HSCT following 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; Estimated life expectancy of more than 12 weeks; Diagnosis of multiple myeloma confirmed by physical examination, pathology, laboratory tests, and imaging studies; Patients with refractory multiple myeloma; Patients with relapsed multiple myeloma; ALT and AST \< 3 times the upper limit of normal; Total bilirubin \< 2.0 mg/dL; Karnofsky Performance Status (KPS) \> 50%; No severe dysfunction of major organs such as liver, kidney, or heart; Prior failure of autologous or allogeneic hematopoietic stem cell transplantation; Ineligible for stem cell transplantation or patients who declined transplantation due to other constraints; Voluntarily willing to receive CAR-T cell therapy for B cell-derived hematologic malignancies; Suitable for peripheral venous blood collection with no contraindications to leukapheresis; Able to understand and sign a written informed consent form.

You may not qualify if:

• Pregnant or lactating women, or women planning pregnancy within 6 months; Presence of infectious diseases (e.g., HIV infection, active tuberculosis); Active hepatitis B or C virus infection; Pre-screening indicates peripheral blood T-cell transduction efficiency \< 10% or expansion fold \< 5× under CD3/CD28 co-stimulation; Abnormal vital signs or inability to cooperate with treatment procedures; Presence of psychiatric or psychological disorders that affect treatment compliance or outcome assessment; History of severe allergy or hypersensitivity, particularly to interleukin-2 (IL-2); Systemic or localized severe infections requiring anti-infective therapy; Significant dysfunction of critical organs such as heart, lung, brain, or kidney; Patients with severe autoimmune diseases; Any other conditions deemed unsuitable for enrollment by the investigator.

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

Central Study Contacts

Kailin Xu

CONTACT

15162166166; lihmd@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro.

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 6, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share