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Safety and Efficacy Evaluation of IM23 CAR-T Cells (IM23CAR-T)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03585517
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Beijing Immunochina Medical Science & Technology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 1, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date July 16, 2018
Estimated Study Start Date  ICMJE July 21, 2018
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2018)
Occurrence of study related adverse events [ Time Frame: 2 years ]
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03585517 on ClinicalTrials.gov Archive Site
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 Safety and Efficacy Evaluation of IM23 CAR-T Cells (IM23CAR-T)
Official Title  ICMJE Safety and Efficacy Evaluation of IM23 CAR-T Cells On CD123+ AML Patients
Brief Summary Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML
Detailed Description Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML and determine the best dosage.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE AML
Intervention  ICMJE Drug: IM23
T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor
Study Arms  ICMJE Experimental: IM23 CART
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD123 CAR will be infused 24-96 hours later.
Intervention: Drug: IM23
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with CD123+ Refractory or Relapsed AML
  • To be aged 3 to 80 years
  • Expression of CD123 in Blast ≥90%
  • ECOG score ≤2
  • Voluntary participation in the clinical trials and sign the informed consent.

Exclusion Criteria:

  • Intracranial hypertension or unconsciousness
  • Respiratory failure
  • CD19 negative
  • Disseminated intravascular coagulation
  • ALT /AST>3 x normal value; Creatinine> 1.5 x normal value; Bilirubin >2.0 x -normal value
  • Hematosepsis or Uncontrolled active infection
  • Uncontrolled diabetes
  • Abalienation;
  • Patients in pregnancy or breast-feeding period
  • Previously treatment with any gene therapy products
  • Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: xian lu, PHd 86 ext 189-1157-6946 luxinan@immunochina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585517
Other Study ID Numbers  ICMJE YMCART201806
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Immunochina Medical Science & Technology Co., Ltd.
Study Sponsor  ICMJE Beijing Immunochina Medical Science & Technology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing Immunochina Medical Science & Technology Co., Ltd.
Verification Date July 2018

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