Clinical trial NCT05740891: AHSCT Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: AHSCT
BCMA CAR-T
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Yake Biotechnology Ltd.
First posted: 2023-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Baseline up to 28 days after BCMA CAR T-cells infusion
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: 24 months after cell infusion
Secondary outcomes:
measure: overall response rate
timeFrame: Up to 30 months
measure: Complete response rate(CRR)
timeFrame: Baseline up to 2 years after BCMA CAR T-cells infusion
measure: Overall survival (OS)
timeFrame: Month 6,12,18and 24
measure: Duration of response(DOR)
timeFrame: Month 6,12,18and 24
measure: Progression-free survival (PFS)
timeFrame: Month 6,12,18and 24
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital of medical college of zhejiang university
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: He Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: