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CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
CXCR4 modified anti-BCMA CAR T cells
Sponsored by
Sichuan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female, 18 to 75 years old.
  2. The expected survival ≥ 12 week
  3. ECOG ≤ 2
  4. Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse
  5. The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease
  6. Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection
  7. Patients can take effective contraceptive measures during the trial period and 1 year after the infusion
  8. Voluntary informed consent is given, agree to follow the trial treatment and visit plan

Exclusion Criteria:

  1. Patients with other uncontrollable cancer
  2. Active hepatitis B, hepatitis C, or HIV infection
  3. Other uncontrolled active disease
  4. Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases
  5. Patients with uncontrollable hypertension(≥ grade II)
  6. Patients with history of uncontrollable mental illness
  7. Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded)
  8. Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment;
  9. Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period;
  10. Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment;
  11. Patients had other conditions that were not appropriate for the study determined by the researchers.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CXCR4 modified anti-BCMA CAR T cell therapy

    Arm Description

    CAR T cell therapy

    Outcomes

    Primary Outcome Measures

    Dose limiting toxicities (DLT)
    Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Secondary Outcome Measures

    ORR (overall response rate)
    Proportion of subjects with the best overall response (BOR)
    CRR (complete response rate)
    Proportion of subjects with the BOR of sCR+CR at Month 3

    Full Information

    First Posted
    November 30, 2020
    Last Updated
    April 7, 2021
    Sponsor
    Sichuan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04727008
    Brief Title
    CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma
    Official Title
    Phase I Study of A CXCR4 Modified BCMA CAR-T in Patients With Refractory and/or Relapsed Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 3, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sichuan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CXCR4 modified anti-BCMA CAR T cell therapy
    Arm Type
    Experimental
    Arm Description
    CAR T cell therapy
    Intervention Type
    Biological
    Intervention Name(s)
    CXCR4 modified anti-BCMA CAR T cells
    Intervention Description
    intravenous infusion
    Primary Outcome Measure Information:
    Title
    Dose limiting toxicities (DLT)
    Description
    Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
    Time Frame
    2 years
    Title
    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    ORR (overall response rate)
    Description
    Proportion of subjects with the best overall response (BOR)
    Time Frame
    3 months,6 months
    Title
    CRR (complete response rate)
    Description
    Proportion of subjects with the BOR of sCR+CR at Month 3
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female, 18 to 75 years old. The expected survival ≥ 12 week ECOG ≤ 2 Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection Patients can take effective contraceptive measures during the trial period and 1 year after the infusion Voluntary informed consent is given, agree to follow the trial treatment and visit plan Exclusion Criteria: Patients with other uncontrollable cancer Active hepatitis B, hepatitis C, or HIV infection Other uncontrolled active disease Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases Patients with uncontrollable hypertension(≥ grade II) Patients with history of uncontrollable mental illness Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded) Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment; Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period; Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment; Patients had other conditions that were not appropriate for the study determined by the researchers.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    DAN LI, Ph.D
    Phone
    +86(028)85423525
    Email
    lidan@wchscu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    FUCHUN GUO, MD
    Phone
    +86(028)85423525
    Email
    FCguo0797@wchscu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

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