Tests CAR-T cell therapy after stem cell transplant in multiple myeloma
Tests CAR-T cell therapy after stem cell transplant in adults with newly diagnosed multiple myeloma.
Plain-language title generated from the registry record
Registry title: Phase II Clinical Study on the Safety and Efficacy of Combined CAR-T Therapy Following Autologous Stem Cell Transplantation in Multiple Myeloma
Key facts
- Where
- Xuzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07034755, who can take part
Where in China
- The affiliated hospital of xuzhou medical universityXuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Affiliated Hospital of Xuzhou Medical University
- Trial code
- NCT07034755
- Record updated
- 2 July 2025
- Original description
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.Read full original descriptionShow less
Phase II Clinical Study on the Safety and Efficacy of Combined CAR-T Therapy Following Autologous Stem Cell Transplantation in Multiple Myeloma
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.
Inclusion: 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: Infectious diseases(e.g., HIV, active tuberculosis); Active hepatitis B or C infection; 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; Feasibility assessment showing lymphocyte-targeted transfection rate <10% or insufficient expansion (<5-fold) under CD3/CD28 co-stimulation; Pregnancy or lactation, or women planning pregnancy within the next 6 months; Abnormal vital signs or inability to cooperate with examinations.