A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

February 17, 2023 updated by: He Huang, Zhejiang University

Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, College of Medicine, Zhejiang University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.Age and gender unlimited;
  • 2.According to the IMWG2014 standard, diagnosis as multiple myeloma;
  • 3.According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma;
  • 4.Abnormal plasmocyte BCMA expression positive;
  • 5.Echocardiography shows the left ventricular ejection score (LVEF) ≥50%;
  • 6.The subject has no lung activity infection;
  • 7.Expected life time is more than 3 months;
  • 8.ECOG score 0-2 score;
  • 9.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
This is a single arm clinical trial.
Drug: BCMA CAR-T cells
Each subject receive BCMA CAR T-cells by intravenous infusion
Other Names:
  • BCMA CAR-T cells injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Baseline up to 2 years after BCMA CAR T-cells infusion
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Baseline up to 2 years after BCMA CAR T-cells infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiple Myeloma (MM), Overall response rate (ORR)
Time Frame: At Month 1, 3, 6, 12, 18 and 24
Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 6, 12, 18 and 24
At Month 1, 3, 6, 12, 18 and 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
Partial response Rate (PRR)
Time Frame: Up to 2 years after BCMA CAR T-cells infusion
Proportion of subjects who achieved a partial response (PR)
Up to 2 years after BCMA CAR T-cells infusion
Overall survival
Time Frame: Up to 2 years after BCMA CAR T-cells infusion
Death from any cause from the beginning of cell transfusion
Up to 2 years after BCMA CAR T-cells infusion

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 (Actual)

January 30, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 3, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20210024C-R4

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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