Autologous Transplantation Combined With BCMA CAR-T in the Treatment of Young NDMM

NCT ID: NCT07169500

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2030-03-02

Brief Summary

To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of young NDMM

Detailed Description

This study is a single center, prospective clinical study initiated by researchers to evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation combined with BCMA-CART cells in the treatment of young patients with newly diagnosed multiple myeloma, aiming to explore the safety and efficacy of ASCT combined with BCMA-CART in the treatment of young patients with NDMM.

Conditions

Multiple Myeloma

Study Design

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

Study Groups

BCMA CART

The subject underwent ASCT and BCMA-CART infusion

Group Type: EXPERIMENTAL

CAR-T

Intervention Type: BIOLOGICAL

Chimeric antigen receptor T cells (car-t) are genetically engineered MHC independent tumor specific killer cells.

Interventions

CAR-T

Chimeric antigen receptor T cells (car-t) are genetically engineered MHC independent tumor specific killer cells.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Young newly diagnosed multiple myeloma (NDMM), 18-50 years old, suitable for ASCT;

1. The subjects voluntarily participated in the study and signed the informed consent form (ICF) by themselves or their legal guardians;

2. The subject must have proper organ function and meet all the following inspection results:

total serum bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; creatinine clearance (CrCl) (Cockcroft Gault formula) ≥ 40ml/min; prothrombin time (PT) ≤ 1.5 × ULN, partial prothrombin time (APTT) < 1.5 × ULN; international normalized ratio (INR) < 1.5 × ULN; hemoglobin (HB) ≥ 60g/L; absolute neutrophil count (ANC) ≥ 1.0 × 10^9/lL(no growth factors such as granulocyte colony stimulating factor [G-CSF] have been received within 7 days before the laboratory examination in the screening period); absolute lymphocyte count (ALC) ≥ 0.5 × 10^9/L; platelet (PLT) ≥ 50 × 10^9/L (no platelet transfusion within 7 days before the laboratory examination in the screening period); left ventricular ejection fraction (LVEF) ≥ 45%; blood oxygen saturation (SpO2) ≥ 92%;

3. The ECOG score is 0-1. See Appendix V for ECOG score;

4. Estimated survival ≥ 3 months;

5. The pregnancy test of fertile female subjects should be negative and not during lactation.

Exclusion Criteria

1. Have a history of allergy to any component in cell products;

2. Serious heart disease, including but not limited to:

myocardial infarction, cardiac angioplasty or stent implantation within 6 months before signing ICF; unstable angina; severe arrhythmia; history of severe non ischemic cardiomyopathy; congestive heart failure (New York Heart Association [NYHA] class III or IV), see Appendix II for NYHA score;

3. History of autologous / allogeneic hematopoietic stem cell transplantation;

4. Stroke or seizure within 6 months before signing ICF;

5. Have autoimmune diseases, immunodeficiency or other diseases that need immunosuppressant treatment;

6. Within 3 years before signing the ICF, patients with malignant tumors other than multiple myeloma, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, breast ductal carcinoma in situ after radical surgery, and carcinoma in situ in other parts one year after radical surgery, and there has been no treatment and no sign of recurrence in the screening period;

7. The presence of uncontrolled active infection;

8. Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;

9. One week before lymphocyte collection, the memory is under any of the following conditions:

the detection value of hepatitis B virus (HBV) DNA in peripheral blood is higher than the lower limit of detection; hepatitis C virus (HCV) antibody positive and peripheral HCV-RNA positive.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Taihe Chunyu Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, China

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Xu, MD

Role: CONTACT

xuyan1@ihcams.ac.cn

13920593907

Facility Contacts

Yan Xu, MD

Role: primary

xuyan1@ihcams.ac.cn

13920593907 ext. +86

Other Identifiers

IIT2025025

Identifier Type: -

Identifier Source: org_study_id