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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740891
• Other study ID #: IIT20210027C-R3
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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