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Allogeneic CART-33 for Relapsed/Refractory CD33+ AML

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: NCT02799680
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).

Condition or disease Intervention/treatment Phase
Relapsed and/or Refractory CD33+ AML Biological: allogeneic CART-33 Phase 1

Detailed Description:
The relapsed and/or refractory AML patients will receive infusions of allogeneic CART-33 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Relapsed and/or Refractory CD33-positive Acute Myeloid Leukemia by Infusions of Allogeneic CART-33
Study Start Date : October 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2018


Arms and Interventions

Arm Intervention/treatment
Experimental: allogeneic CART-33
infusions of allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)
Biological: allogeneic CART-33
allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)


Outcome Measures

Primary Outcome Measures :
  1. Occurrence of study related adverse events [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. Overall response rate of allogeneic CART-33 [ Time Frame: up to 24 weeks ]
    A response is defined as: (1) a morphologic complete remission (CR) or (2) a complete remission with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2015) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR

  2. Disease-free survival [ Time Frame: up to 24 weeks ]
  3. Overall survival [ Time Frame: up to 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 50 years
  • Patient with relapsed and/or refractory CD33 positive acute myeloid leukemia (AML)
  • Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

  • Previous treatment with investigational gene or cell therapy medicine products
  • CD33 negative leukemia
  • Any uncontrolled active medical disorder that would preclude participation as outlined
  • Pregnant or lactating women
Contacts and Locations

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): NCT02799680


Contacts
Contact: Huisheng Ai, MD 861066947135

Locations
China, Beijing
Affiliated Hospital of Academy of Military Medical Sciences Recruiting
Beijing, Beijing, China, 100071
Contact: Huisheng Ai, MD    86-1066947126    huishengai@163.com   
Principal Investigator: Huisheng Ai, MD         
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, MD    86-13651392893    hanwdrsw@sina.com   
Principal Investigator: Weidong Han, MD         
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Chinese PLA General Hospital
Investigators
Study Chair: Huisheng Ai, MD Affiliated Hospital of Academy of Military Medical Sciences
More Information

Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02799680     History of Changes
Other Study ID Numbers: CART-AML-2015
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
CART
AML