Back to resultsStudy of BCMA CAR-T in Multiple Myeloma
Primary Purpose
Relapsed and Refractory Multiple Myeloma
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Anti-BCMA CAR T cells
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed and Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Male or female, 18 to 70 years old (including 18 and 70 years old)
- BCMA antigen diagnosed by pathology and histological examination was positive
- ECOG ≤2，and the excepted survival ≥ 3 months
- Patients with BCMA+ myeloma who received ≥ 1 line of chemoradiotherapy or tumor relapsed
- The main organs function is good; （1） liver function: ALT/AST<3 times normal value upper limit (ULN) and total bilirubin <34.2 (mol/L); （2） renal function: creatinine <220 mu /L,GFR > 30mL/min; （3） lung function: blood oxygen saturation is greater than 95%; （4） cardiac function: left ventricular ejection fraction (LVEF) is greater than 50%;
- Platelets > 40 billion/L;
- Patients without any anti-cancer treatment such as chemotherapy，radiotherapy, immunotherapy（ immunosuppressive drugs ）within 2-4 weeks before, and the treatment-related toxicity reaction ≤1 level prior to enrollment（except low toxicity lose hair for example）
- Venous channel is unobstructed, which can meet the needs of intravenous drip;
- Voluntary informed consent is given, agree to follow the trial treatment and visit plan.
Exclusion Criteria:
- Patients with allergy to large molecules such as antibodies or cytokines;
- More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to 4 weeks prior enrollment;
- Patients with severe autoimmune diseases or immunodeficiency diseases;
- Patients treated with other immune cellular products (DC, CIK, T, NK, and CART products with CD19 or other targets);
- Patients with uncontrollable infectious disease in the first 4 weeks of treatment;
- Active hepatitis B DNA > 1000copy/mL/ , hepatitis C positive, (HCV positive resistance, HCV RNA positive);
- Patients participated in other clinical trials within 6 weeks prior enrollment;
- Patients with mental illness;
- Patients with drug abuse/addiction and medical, psychological or social conditions may interfere with the study or evaluate the results of the study;
- Patients have alcohol dependence;
- 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 had other conditions that were not appropriate for the group determined by the researchers.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anti-BCMA CAR T cells
Arm Description
Total dose of 0.5-6 millions /kg cells will be administered at day -2, day -1 and day 0 by split dose (30%, 30% and 40% respectively).
Outcomes
Primary Outcome Measures
The safety of CAR T is evaluated to determine if CRS occurred
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03559764
First Posted
May 8, 2018
Last Updated
June 14, 2018
Sponsor
Allife Medical Science and Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03559764
Brief Title
Study of BCMA CAR-T in Multiple Myeloma
Official Title
Clinical Study on the Safety and Efficacy of Anti-BCMA CAR T Cells With Relapsed and Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allife Medical Science and Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.
Detailed Description
Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.CAR - T cells was taken in the form of genetic modification, and specific identified target antigen monoclonal antibody of single variable region (scFv) expression in T cell surface, and coupled with the activation of intracellular proliferation signal domain. The study will follow a 3 + 3 design of dose-escalating cohorts. After a patient enrolls,leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce anti- BCMA CAR T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient. Treated patients will undergo serial measurements of safety, tolerability and response.
In order to lay a foundation for the application of relapsed/refractory multiple myeloma patients with CAR-T therapy，objects are refractory/ relapsed patients with multiple myeloma,and plans to into the group of the number of cases in 20 cases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed and Refractory Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-BCMA CAR T cells
Arm Type
Experimental
Arm Description
Total dose of 0.5-6 millions /kg cells will be administered at day -2, day -1 and day 0 by split dose (30%, 30% and 40% respectively).
Intervention Type
Biological
Intervention Name(s)
Anti-BCMA CAR T cells
Intervention Description
Transparent colorless or slightly yellow liquid
Primary Outcome Measure Information:
Title
The safety of CAR T is evaluated to determine if CRS occurred
Description
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Time Frame
Day 3-Year 2 after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 18 to 70 years old (including 18 and 70 years old)
BCMA antigen diagnosed by pathology and histological examination was positive
ECOG ≤2，and the excepted survival ≥ 3 months
Patients with BCMA+ myeloma who received ≥ 1 line of chemoradiotherapy or tumor relapsed
The main organs function is good; （1） liver function: ALT/AST<3 times normal value upper limit (ULN) and total bilirubin <34.2 (mol/L); （2） renal function: creatinine <220 mu /L,GFR > 30mL/min; （3） lung function: blood oxygen saturation is greater than 95%; （4） cardiac function: left ventricular ejection fraction (LVEF) is greater than 50%;
Platelets > 40 billion/L;
Patients without any anti-cancer treatment such as chemotherapy，radiotherapy, immunotherapy（ immunosuppressive drugs ）within 2-4 weeks before, and the treatment-related toxicity reaction ≤1 level prior to enrollment（except low toxicity lose hair for example）
Venous channel is unobstructed, which can meet the needs of intravenous drip;
Voluntary informed consent is given, agree to follow the trial treatment and visit plan.
Exclusion Criteria:
Patients with allergy to large molecules such as antibodies or cytokines;
More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to 4 weeks prior enrollment;
Patients with severe autoimmune diseases or immunodeficiency diseases;
Patients treated with other immune cellular products (DC, CIK, T, NK, and CART products with CD19 or other targets);
Patients with uncontrollable infectious disease in the first 4 weeks of treatment;
Active hepatitis B DNA > 1000copy/mL/ , hepatitis C positive, (HCV positive resistance, HCV RNA positive);
Patients participated in other clinical trials within 6 weeks prior enrollment;
Patients with mental illness;
Patients with drug abuse/addiction and medical, psychological or social conditions may interfere with the study or evaluate the results of the study;
Patients have alcohol dependence;
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 had other conditions that were not appropriate for the group determined by the researchers.
12. IPD Sharing Statement
Learn more about this trial
Study of BCMA CAR-T in Multiple Myeloma
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