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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05740891
Other study ID # IIT20210027C-R3
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 2023
Est. completion date March 2025

Study information

Verified date February 2023
Source Zhejiang University
Contact He Huang, MD
Phone +8613605714822
Email hehuangyu@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 30 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BCMA CAR-T cells injection
Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells

Locations

Country Name City State
China The first affiliated hospital of medical college of zhejiang university Hangzhou Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Zhejiang University Yake Biotechnology Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicity (DLT) Adverse events assessed according to NCI-CTCAE v5.0 criteria Baseline up to 28 days after BCMA CAR T-cells infusion
Primary Incidence of treatment-emergent adverse events (TEAEs) Incidence of treatment-emergent adverse events [Safety and Tolerability] 24 months after cell infusion
Secondary overall response rate The number of response patients/the number of total patients Up to 30 months
Secondary Complete response rate(CRR) Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi) Baseline up to 2 years after BCMA CAR T-cells infusion
Secondary Overall survival (OS) Assessment of OS at Month 6,12,18and 24 Month 6,12,18and 24
Secondary Duration of response(DOR) Assessment of OS at Month 6,12,18and 24 Month 6,12,18and 24
Secondary Progression-free survival (PFS) Assessment of PFS at Month 6,12,18and 24 Month 6,12,18and 24
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