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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BCMA CAR-T cells injection
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring AHSCT, BCMA CAR-T

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The first affiliated hospital of medical college of zhejiang universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Refractory and relapsed multiple myeloma

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]

Secondary Outcome Measures

overall response rate
The number of response patients/the number of total patients
Complete response rate(CRR)
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Overall survival (OS)
Assessment of OS at Month 6,12,18and 24
Duration of response(DOR)
Assessment of OS at Month 6,12,18and 24
Progression-free survival (PFS)
Assessment of PFS at Month 6,12,18and 24

Full Information

First Posted
February 3, 2023
Last Updated
February 13, 2023
Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05740891
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
AHSCT, BCMA CAR-T

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Refractory and relapsed multiple myeloma
Intervention Type
Drug
Intervention Name(s)
BCMA CAR-T cells injection
Intervention Description
Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells
Primary Outcome Measure Information:
Title
Dose-limiting toxicity (DLT)
Description
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time Frame
Baseline up to 28 days after BCMA CAR T-cells infusion
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Time Frame
24 months after cell infusion
Secondary Outcome Measure Information:
Title
overall response rate
Description
The number of response patients/the number of total patients
Time Frame
Up to 30 months
Title
Complete response rate(CRR)
Description
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Time Frame
Baseline up to 2 years after BCMA CAR T-cells infusion
Title
Overall survival (OS)
Description
Assessment of OS at Month 6,12,18and 24
Time Frame
Month 6,12,18and 24
Title
Duration of response(DOR)
Description
Assessment of OS at Month 6,12,18and 24
Time Frame
Month 6,12,18and 24
Title
Progression-free survival (PFS)
Description
Assessment of PFS at Month 6,12,18and 24
Time Frame
Month 6,12,18and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, MD
Phone
+8613605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongxian Hu, MD
Phone
+8615957162012
Email
huyongxian2000@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of medical college of zhejiang university
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name & Degree
Yongxian Hu, MD
Phone
+8615957162012
Email
huyongxian2000@aliyun.com

12. IPD Sharing Statement

Learn more about this trial

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

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