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Trial Title:
AHSCT Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
NCT ID:
NCT05740891
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
AHSCT
BCMA CAR-T
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BCMA CAR-T cells injection
Description:
Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells
Arm group label:
Treatment Group
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.
Criteria for 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;
- 11、Any situation that the researchers believe may increase the risk of patients or
interfere with the test results.
Gender:
All
Minimum age:
30 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The first affiliated hospital of medical college of zhejiang university
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
He Huang, MD
Phone:
86-13605714822
Email:
hehuangyu@126.com
Contact backup:
Last name:
Yongxian Hu, MD
Phone:
+8615957162012
Email:
huyongxian2000@aliyun.com
Start date:
March 2023
Completion date:
March 2025
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Yake Biotechnology Ltd.
Agency class:
Industry
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740891
