NCT07034755Not yet recruiting
Phase II Clinical Study on the Safety and Efficacy of Combined CAR-T Therapy Following Autologous Stem Cell Transplantation in Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 2 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 17 May 2025
- Start date
- Jul 2025
- Primary completion date
- Mar 2028
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Diseases
- Multiple myeloma
- NCT number
- NCT07034755
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Jul 2025 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Feasibility assessment showing lymphocyte-targeted transfection rate \<10% or insufficient expansion (\<5-fold) under CD3/CD28 co-stimulation
Other
- Pregnancy or lactation, or women planning pregnancy within the next 6 months
- Abnormal vital signs or inability to cooperate with examinations
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.