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

February 13, 2023 updated by: He Huang, Zhejiang University

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 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The first affiliated hospital of medical college of zhejiang university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Month 6,12,18and 24
Assessment of PFS at Month 6,12,18and 24
Month 6,12,18and 24
Overall survival (OS)
Time Frame: Month 6,12,18and 24
Assessment of OS at Month 6,12,18and 24
Month 6,12,18and 24
Duration of response(DOR)
Time Frame: Month 6,12,18and 24
Assessment of OS at Month 6,12,18and 24
Month 6,12,18and 24
Complete response rate(CRR)
Time Frame: 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)
Baseline up to 2 years after BCMA CAR T-cells infusion
overall response rate
Time Frame: Up to 30 months
The number of response patients/the number of total patients
Up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

Yake Biotechnology Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Estimate)

February 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20210027C-R3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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