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Study of BCMA CAR-T in Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03559764
Recruitment Status : Not yet recruiting
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Allife Medical Science and Technology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 8, 2018
First Posted Date  ICMJE June 18, 2018
Last Update Posted Date June 18, 2018
Estimated Study Start Date  ICMJE June 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
The safety of CAR T is evaluated to determine if CRS occurred [ Time Frame: Day 3-Year 2 after injection ]
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of BCMA CAR-T in Multiple Myeloma
Official Title  ICMJE Clinical Study on the Safety and Efficacy of Anti-BCMA CAR T Cells With Relapsed and Refractory Multiple Myeloma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed and Refractory Multiple Myeloma
Intervention  ICMJE Biological: Anti-BCMA CAR T cells
Transparent colorless or slightly yellow liquid
Study Arms  ICMJE Experimental: Anti-BCMA CAR T cells
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: Biological: Anti-BCMA CAR T cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, 18 to 70 years old (including 18 and 70 years old)
  2. BCMA antigen diagnosed by pathology and histological examination was positive
  3. ECOG ≤2,and the excepted survival ≥ 3 months
  4. Patients with BCMA+ myeloma who received ≥ 1 line of chemoradiotherapy or tumor relapsed
  5. 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%;
  6. Platelets > 40 billion/L;
  7. 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)
  8. Venous channel is unobstructed, which can meet the needs of intravenous drip;
  9. Voluntary informed consent is given, agree to follow the trial treatment and visit plan.

Exclusion Criteria:

  1. Patients with allergy to large molecules such as antibodies or cytokines;
  2. More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to 4 weeks prior enrollment;
  3. Patients with severe autoimmune diseases or immunodeficiency diseases;
  4. Patients treated with other immune cellular products (DC, CIK, T, NK, and CART products with CD19 or other targets);
  5. Patients with uncontrollable infectious disease in the first 4 weeks of treatment;
  6. Active hepatitis B DNA > 1000copy/mL/ , hepatitis C positive, (HCV positive resistance, HCV RNA positive);
  7. Patients participated in other clinical trials within 6 weeks prior enrollment;
  8. Patients with mental illness;
  9. Patients with drug abuse/addiction and medical, psychological or social conditions may interfere with the study or evaluate the results of the study;
  10. Patients have alcohol dependence;
  11. 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;
  12. Patients had other conditions that were not appropriate for the group determined by the researchers.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03559764
Other Study ID Numbers  ICMJE BCMA CAR T-HNRM-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allife Medical Science and Technology Co., Ltd.
Study Sponsor  ICMJE Allife Medical Science and Technology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Allife Medical Science and Technology Co., Ltd.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP