AHSCT Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Drug: BCMA CAR-T cells injection
- Registration Number
- NCT05740891
- Lead Sponsor
- Zhejiang University
- Brief Summary
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
- Detailed Description
This is a prospectiv , single arm, open-label, single-center study. This study is indicated for refractory and relapsed multiple myeloma. It aims to evaluate the safety and effectiveness of autologous hematopoietic stem cell transplantation combined with BCMA CAR-T to treat refractory and relapsed multiple myeloma. The main research is completely alleviated, overall reaction rate, and recurrence rate,etc. 50 patients will be enrolled.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 1、BCMA positive accompanied by refractory/relapsed and resistance;
- 2、Patients with the tumor load is high and cannot be transplanted directly, before transplantation. Reduce the load through CAR-T treatment to prepare for transplantation;
- 3、Patient relapses after transplantation,donor lymphocyte infusion Invalid. The donor cells in the recipient body can be used or the donor cells can be collected directly.Prepare CAR-T to prevent recurrence and induce relapsing;
- 4、Repeated MRD (+) refractory drug resistant cases;
- 5、Male or female, 30-75 years old;
- 6、Anticipated survival time more than 12 weeks
- 7、Transplant subjects, regardless of their previous treatment, are eligible for inclusion after relapse；
- 8、Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
- 9、Those who voluntarily participate in the trial and sign the informed consent form
- 1、Patients with the history of epilepsy or other CNS disease；
- 2、Patients with prolonged QT interval time or severe heart disease；
- 3、Pregnant or breastfeeding;
- 4、Active infection with no cure;
- 5、Patients with active hepatitis B or C infection;
- 6、Previously treated with any genetic therapy;
- 7、The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- 8、Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- 9、Those who suffer from other uncontrolled diseases are not suitable to join the study;
- 10、HIV infection;
- 11、Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group BCMA CAR-T cells injection Refractory and relapsed multiple myeloma
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity (DLT) Baseline up to 28 days after BCMA CAR T-cells infusion Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs) 24 months after cell infusion Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
- Secondary Outcome Measures
Name Time Method overall response rate Up to 30 months The number of response patients/the number of total patients
Progression-free survival (PFS) Month 6,12,18and 24 Assessment of PFS at Month 6,12,18and 24
Complete response rate(CRR) Baseline up to 2 years after BCMA CAR T-cells infusion Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Overall survival (OS) Month 6,12,18and 24 Assessment of OS at Month 6,12,18and 24
Duration of response(DOR) Month 6,12,18and 24 Assessment of OS at Month 6,12,18and 24
Trial Locations
- Locations (1)
The first affiliated hospital of medical college of zhejiang university
🇨🇳Hangzhou, Zhejiang, China