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

Sponsor

Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05740891

Collaborator

Yake Biotechnology Ltd. (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: BCMA CAR-T cells injection	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Refractory and relapsed multiple myeloma	Drug: BCMA CAR-T cells injection Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells

Arm

Intervention/Treatment

Experimental: Treatment Group

Refractory and relapsed multiple myeloma

Drug: BCMA CAR-T cells injection

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

Outcome Measures

Primary Outcome Measures

Dose-limiting toxicity (DLT) [Baseline up to 28 days after BCMA CAR T-cells infusion]
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs) [24 months after cell infusion]
Incidence of treatment-emergent adverse events [Safety and Tolerability]

Secondary Outcome Measures

overall response rate [Up to 30 months]
The number of response patients/the number of total patients
Complete response rate(CRR) [Baseline up to 2 years after BCMA CAR T-cells infusion]
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Overall survival (OS) [Month 6,12,18and 24]
Assessment of OS at Month 6,12,18and 24
Duration of response(DOR) [Month 6,12,18and 24]
Assessment of OS at Month 6,12,18and 24
Progression-free survival (PFS) [Month 6,12,18and 24]
Assessment of PFS at Month 6,12,18and 24

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of medical college of zhejiang university	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Zhejiang University
Yake Biotechnology Ltd.

Investigators

Principal Investigator: He Huang, MD, First Affiliated Hospital of Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

He Huang, The President of The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05740891

Other Study ID Numbers:

IIT20210027C-R3

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by He Huang, The President of The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang University

AHSCT

BCMA CAR-T

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Feb 23, 2023