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A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy

Sponsor
Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04541368
Collaborator
Yake Biotechnology Ltd. (Industry)
50
Enrollment
1
Location
1
Arm
72
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical trial for the safety and efficacy of CS1-targeted CAR-T Cells therapy for relapsed multiple myeloma after BCMA CAR-T cells therapy

Condition or Disease Intervention/Treatment Phase
  • Drug: CS1 Targeted CAR T-cells
 Early Phase 1

Detailed Description

This is a single arm, open-label, single-center study. This study is indicated for relapsed CS1+ multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 50 patients will be enrolled for this trial. Primary objective is to explore the safety, main consideration is dose-related safety.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 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 CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy
Anticipated Study Start Date :
Dec 31, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Administration of CS1 Targeted CAR T-cells

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

Drug: CS1 Targeted CAR T-cells
Each subject receive CS1 Targeted CAR T-cells by intravenous infusion
Other Names:
  • CS1 Targeted CAR T-cells injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dose-limiting toxicity (DLT) [Baseline up to 28 days after CS1 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 CS1 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 [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:
    30 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologically confirmed diagnosis of CS1+ multiple myeloma (MM)：

    2. Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA expression;

    3. Relapsed after hematopoietic stem cell transplantation;

    4. Cases with recurrent positive minimal residual disease;

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

    6. Anticipated survival time more than 12 weeks;

    7. Male or female aged 30-75 years;

    8. 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 hemorrhagicdiseases;

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

    3. Pregnant (or lactating) women;

    4. Patients with severe active infections (excluding simple urinary tract infectionand bacterial pharyngitis);

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

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

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

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

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

    10. Patients with HIV infection;

    11. 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，College of Medicine, 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:
    NCT04541368
    Other Study ID Numbers:
    • CS1-ZhejiangU
    First Posted:
    Sep 9, 2020
    Last Update Posted:
    Dec 10, 2020
    Last Verified:
    Dec 1, 2020
    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
    CS1
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Dec 10, 2020