Phase II Clinical Study on the Safety and Efficacy of Combined CAR-T Therapy Following Autologous Stem Cell Transplantation in Multiple Myeloma

NCT07034755 | Not Yet Recruiting DMC

• 1 other identifier: SYYY-LL-202502
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chimeric Antigen Receptor T-Cell (CAR-T) immunotherapy is a rapidly developing novel approach in adoptive immunotherapy for tumors in recent years. Its main characteristic lies in genetically engineering T cells to express tumor antigen-specific receptors, thereby endowing them with targeting capability, cytotoxicity, and persistence. This approach has demonstrated remarkable efficacy in relapsed/refractory hematologic malignancies. Research on multiple myeloma (MM)-specific CAR-T cells has also been progressively conducted with promising outcomes, establishing CAR-T cell therapy as an effective new treatment strategy for MM. Notably, targets such as B-cell maturation antigen (BCMA) and GPRC5D have emerged as prominent therapeutic targets for CAR-T cell therapy. Therefore, we propose to evaluate the efficacy and safety of sequential CAR-T therapy following autologous hematopoietic stem cell transplantation (ASCT) in newly diagnosed MM patients who achieve partial response (PR) or better after four cycles of first-line chemotherapy but fail to attain complete response (CR), or those who achieve CR but present with high-risk factors. The clinical data from this study will provide evidence-based support for novel treatment strategies in this subset of MM patients.

Conditions

Multiple Myeloma (MM); Allogeneic Hematopoietic Stem Cell Transplantation (HSCT); Chimeric Antigen Receptor T-cell

Keywords

Chimeric Antigen Receptor T-Cell; allogeneic Hematopoietic Stem Cell Transplantation (HSCT); multiple myeloma (MM)

Outcome Measures

Primary Outcomes (3)

• Progression-Free Survival(PFS):Time between treatment and disease progression or death

  The efficacy of autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy was evaluated in patients with multiple myeloma who either achieved partial response (PR) or better (but not complete response \[CR\]) after four cycles of first-line chemotherapy, or those who achieved CR but had high-risk factors.

  Pre-hematopoietic stem cell transplant evaluation、assessed at two weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after CAR-T infusion

• MRD

  Refers to residual tumor cells or small lesions that still exist in the patient's body after treatment but cannot be detected by imaging methods

  Efficacy was re-evaluated at 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year after CAR-T infusion

• OS

  The time from the time the patient receives treatment to the patient's death due to any cause

  Efficacy was re-evaluated at 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year after CAR-T infusion

Secondary Outcomes (1)

• To assess the safety of transplantation in combination with CAR-T

  Efficacy was reassessed at two weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after CAR-T infusion

Study Arms (1)

The efficacy of autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy

EXPERIMENTAL

This study evaluates the efficacy and safety of sequential autologous hematopoietic stem cell transplantation (auto-HSCT) followed by CAR-T cell therapy in newly diagnosed multiple myeloma (MM) patients who achieved partial response (PR) or better but failed to attain complete response (CR) after four cycles of first-line chemotherapy, or those who achieved CR but harbored high-risk factors. The clinical data from this research will provide supportive evidence for novel therapeutic strategies in this subset of MM patients.

Other: autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy

Interventions

autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy OTHER

The efficacy of autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy was evaluated in patients with multiple myeloma who either achieved partial response (PR) or better (but not complete response \[CR\]) after four cycles of first-line chemotherapy, or those who achieved CR but had high-risk factors.

The efficacy of autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy

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: 18-70 years old
• Expected survival: \>12 weeks
• Diagnosis: Multiple myeloma confirmed by physical examination, pathological examination, laboratory tests, and imaging studies
• Post-chemotherapy status:
• Patients who achieved partial response (PR) or better but failed to reach complete response (CR) after four cycles of first-line chemotherapy Patients who achieved CR after four cycles of first-line chemotherapy but have high-risk factors
• Liver function:
• ALT and AST \< 3 times the upper limit of normal
• Bilirubin \< 2.0 mg/dl
• Performance status: Karnofsky Performance Status (KPS) \>50%
• Organ function: No severe liver, kidney, or heart diseases
• Stem cell transplantation: Eligible for stem cell transplantation
• Venous access: Able to undergo venous blood sampling without contraindications to leukapheresis
• Informed consent: Capable of understanding and voluntarily signing a written informed consent form

You may not qualify if:

• Pregnancy or lactation, or women planning pregnancy within the next 6 months
• Infectious diseases(e.g., HIV, active tuberculosis)
• Active hepatitis B or C infection
• Feasibility assessment showing lymphocyte-targeted transfection rate \<10% or insufficient expansion (\<5-fold) under CD3/CD28 co-stimulation
• Abnormal vital signs or inability to cooperate with examinations
• Psychiatric/psychological disorders precluding treatment compliance or efficacy evaluation
• Severe allergic constitution or history of severe allergies, especially to IL-2
• Systemic or localized severe infection requiring anti-infective therapy
• Severe autoimmune diseases

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead
• Shuyang People's Hospital: collaborator

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

Location

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

Wei Sang,M.D.,, Ph.D.

CONTACT

13645207648; xyfylbl515@xzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)