Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) | — | UNRESOLVED | — |
| Chimeric Antigen Receptor T-cell | — | UNRESOLVED | — |
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- The efficacy of autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy
- description
- 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.
- interventionNames
- Other: autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy
Primary outcomes (3)
- measure
- Progression-Free Survival(PFS):Time between treatment and disease progression or death
- timeFrame
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available