Allogeneic CART-33 for Relapsed/Refractory CD33+ AML

June 10, 2016 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Treatment of Relapsed and/or Refractory CD33-positive Acute Myeloid Leukemia by Infusions of Allogeneic CART-33

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 100071
        • Recruiting
        • Affiliated Hospital of Academy of Military Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 weeks
Disease-free survival
Time Frame: up to 24 weeks
up to 24 weeks
Overall survival
Time Frame: up to 24 weeks
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Collaborators

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 10, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CART-AML-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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