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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.

Brief Summary:
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML

Condition or disease Intervention/treatment Phase
AML Drug: IM23 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of IM23 CAR-T Cells On CD123+ AML Patients
Estimated Study Start Date : July 21, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : November 1, 2020

Arm Intervention/treatment
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.
Drug: IM23
T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585517


Contacts
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Contact: xian lu, PHd 86 ext 189-1157-6946 luxinan@immunochina.com

Locations
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China
Xian Lu Recruiting
Beijing, China
Contact: xian lu    86 ext 86    luxinan@immunochina.com   
Sponsors and Collaborators
Beijing Immunochina Medical Science & Technology Co., Ltd.

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Responsible Party: Beijing Immunochina Medical Science & Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03585517     History of Changes
Other Study ID Numbers: YMCART201806
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

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