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

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

1. Study Title CAR-T Cell Therapy Combined with Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Multiple Myeloma
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. 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. Sample Size A total of 30 patients will be enrolled in this study.
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.

(2) Exclusion Criteria 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.

6. Treatment Protocol 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kailin Xu; Phone Number: 15162166166; Email: lihmd@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: allo-HSCT following CAR-T; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Time from CAR-T infusion to disease progression or death from any cause.	Month 6, 12, 18 and 24
Overall Survival (OS)	Time from CAR-T infusion to death from any cause.	Month 6, 12, 18 and 24

Collaborators and Investigators

• Sponsor: Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 29, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: XYFY2025-KL061-01 (Other Identifier: The Affiliated Hospital oh Xuzhou Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No