AHSCT Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma

Zhejiang University

Status and phase

Enrolling

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: BCMA CAR-T cells injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05740891

IIT20210027C-R3

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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.