Multiple Myeloma
Conditions
Keywords
AHSCT, BCMA CAR-T
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.
Interventions
DRUGBCMA CAR-T cells injection
Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells
Sponsors
Yake Biotechnology Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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; * 11、Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Month 6,12,18and 24 | Assessment of OS at Month 6,12,18and 24 |
| 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 |
| Duration of response(DOR) | Month 6,12,18and 24 | Assessment of OS 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) |
Countries
China
Contacts
Primary ContactHe Huang, MD
Backup ContactYongxian Hu, MD
Outcome results
None listed