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A Study of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Sponsor
Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05430945
Collaborator
Yake Biotechnology Ltd. (Industry)
100
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical Trial for the safety and efficacy of BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma

Condition or Disease Intervention/Treatment Phase
  • Biological: BCMA Targeted CAR T-cells
 Early Phase 1

Detailed Description

In this study, 100 patients with relapsed refractory multiple myeloma were proposed to undergo BCMA CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of BCMA CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on BCMA CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 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-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Anticipated Study Start Date :
Jun 20, 2022
Anticipated Primary Completion Date :
Jun 20, 2025
Anticipated Study Completion Date :
Jun 20, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Administration of BCMA Targeted CAR T-cells

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Biological: BCMA Targeted CAR T-cells
Each subject receive BCMA Targeted CAR T-cells by intravenous infusion
Other Names:
  • BCMA Targeted CAR T-cells injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dose-limiting toxicity (DLT) [Baseline up to 28 days after BCMA targeted CAR T-cells infusion]

      Adverse events assessed according to NCI-CTCAE v5.0 criteria

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

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

    Secondary Outcome Measures

    1. Overall response rate (ORR) [At Day 28]

      Assessment of ORR at Day 28

    2. Overall survival (OS) [At Month 6, 12, 24]

      Assessment of OS at Month 6, 12, 24

    3. Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30) [At Baseline, Month 1, 3, 6, 9 and 12]

      Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12

    4. Instrumental Activities of Daily Living (IADL) score [At Baseline, Month 1, 3, 6, 9 and 12]

      Assessment of Instrumental Activities of Daily Living (IADL) scale [max score: 56, min score: 14, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12

    5. Activities of Daily Living (ADL) score [At Baseline, Month 1, 3, 6, 9 and 12]

      Assessment using Activities of Daily Living (ADL) scale (Barthel Index) [max score: 100, min score: 0, higher scores mean a better outcome] at Baseline, Month 1, 3, 6, 9 and 12

    6. Hospital Anxiety and Depression Scale (HADS) score [At Baseline, Month 1, 3, 6, 9 and 12]

      Assessment of Hospital Anxiety and Depression Scale (HADS) score at Baseline, Month 1, 3, 6, 9 and 12

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Histologically confirmed diagnosis of multiple myeloma (MM):

    1. Patients with BCMA positive relapsed/refractory MM;

    2. Relapsed after hematopoietic stem cell transplantation;

    3. Cases with recurrent positive minimal residual disease;

    4. Repeated MRD(+) refractory resistant cases

    5. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.

    6. Anticipated survival time more than 12 weeks; 3. Transplant patients, regardless of their previous treatment, are eligible after relapse; 4. Those who voluntarily participated in this trial and provided informed consent.

    Exclusion Criteria:
    • Subjects with any of the following exclusion criteria were not eligible for this trial:

    1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;

    2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;

    3. Pregnant (or lactating) women;

    4. With a graft-versus-host response, immunosuppressants are required;

    5. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);

    6. Active infection of hepatitis B virus or hepatitis C virus;

    7. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;

    8. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;

    9. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;

    10. Other uncontrolled diseases that were not suitable for this trial;

    11. Patients with HIV infection;

    12. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital, Medical College, Zhejiang University Hangzhou Zhejiang China 310003

    Sponsors and Collaborators

    • Zhejiang University
    • Yake Biotechnology Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    He Huang, Clinical Professor, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05430945
    Other Study ID Numbers:
    • BCMA-ZhejiangU
    First Posted:
    Jun 24, 2022
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    multiple myeloma
    CAR T-cell therapy
    BCMA
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Jun 24, 2022