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CD123/CLL1 CAR-T Cells for R/R AML (STPHI_0001)

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: NCT03631576
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jianda Hu, Fujian Medical University

Brief Summary:
The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory AML Biological: CD123/CLL1 CAR-T Cells Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD123/CLL1 CAR-T Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : August 10, 2021
Estimated Study Completion Date : August 10, 2021


Arm Intervention/treatment
Experimental: Arm 1
CD123/CLL1 CAR-T Cells treat
Biological: CD123/CLL1 CAR-T Cells
CD123/CLL1 CAR-T Cell Therapy




Primary Outcome Measures :
  1. Leukemia free survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Adverse events that are related to treatment [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Aged < 70 years
  • Patients with relapsed/refractory AML
  • Cardiac: Left ventricular ejection fraction ≥ 50%
  • Adequate renal and hepatic function
  • Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

  • Pregnant or lactating females.
  • Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.

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): NCT03631576


Contacts
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Contact: Jianda Hu, Prof.M.D.Ph.D 86-13959169016 drjiandahu@163.com

Locations
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China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Jianda Hu, Prof.    86-13959169016    drjiandahu@163.com   
Contact: Ting Yang, Prof.    86-13950210357    yang.hopeting@gmail.com   
Principal Investigator: Jianda Hu, Prof.         
Sponsors and Collaborators
Fujian Medical University
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Responsible Party: Jianda Hu, Director of the department of Hematology, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03631576    
Other Study ID Numbers: CART-19-04
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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