autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy
autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy: 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Other conditions deemed unsuitable for inclusion by the investigator
Primary outcome measure(s)
Progression-Free Survival(PFS):Time between treatment and disease progression or death — 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 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.
MRD — Efficacy was re-evaluated at 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year after CAR-T infusion 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
OS — Efficacy was re-evaluated at 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year after CAR-T infusion The time from the time the patient receives treatment to the patient's death due to any cause
Trial sites (1)
Facility
City
Region
Status
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Jiangsu
More The Affiliated Hospital of Xuzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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