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

Sponsor
Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05712083
Collaborator
Yake Biotechnology Ltd. (Industry)
40
Enrollment
1
Location
1
Arm
13.7
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: BCMA CAR-T cells
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Anticipated Study Start Date :
Feb 10, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. Incidence of treatment-emergent adverse events (TEAEs) [Baseline up to 2 years after BCMA CAR T-cells infusion]

      Incidence of treatment-emergent adverse events [Safety and Tolerability]

    Secondary Outcome Measures

    1. Multiple Myeloma (MM), Overall response rate (ORR) [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

    2. 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)

    3. Partial response Rate (PRR) [Up to 2 years after BCMA CAR T-cells infusion]

      Proportion of subjects who achieved a partial response (PR)

    4. Overall survival [Up to 2 years after BCMA CAR T-cells infusion]

      Death from any cause from the beginning of cell transfusion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital, College of Medicine, 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, Clinical Professor, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05712083
    Other Study ID Numbers:
    • IIT20210024C-R4
    First Posted:
    Feb 3, 2023
    Last Update Posted:
    Feb 3, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by He Huang, Clinical Professor, Zhejiang University
    BCMA CAR-T
    Multiple Myeloma
    New Diagnosis
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Feb 3, 2023