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
Overview
- Phase
- Phase 1
- Intervention
- BCMA CAR-T cells injection
- Conditions
- Multiple Myeloma
- Sponsor
- Zhejiang University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Dose-limiting toxicity (DLT)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
He Huang
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Zhejiang University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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;
Arms & Interventions
Treatment Group
Refractory and relapsed multiple myeloma
Intervention: BCMA CAR-T cells injection
Outcomes
Primary Outcomes
Dose-limiting toxicity (DLT)
Time Frame: 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)
Time Frame: 24 months after cell infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Secondary Outcomes
- overall response rate(Up to 30 months)
- Progression-free survival (PFS)(Month 6,12,18and 24)
- Complete response rate(CRR)(Baseline up to 2 years after BCMA CAR T-cells infusion)
- Overall survival (OS)(Month 6,12,18and 24)
- Duration of response(DOR)(Month 6,12,18and 24)