Allogeneic CART-33 for Relapsed/Refractory CD33+ AML

NCT ID: NCT02799680

Last Updated: 2016-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-05-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Relapsed and/or Refractory CD33+ AML

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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allogeneic CART-33

infusions of allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)

Group Type EXPERIMENTAL

allogeneic CART-33

Intervention Type BIOLOGICAL

allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)

Interventions

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allogeneic CART-33

allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huisheng Ai, MD

Role: STUDY_CHAIR

Affiliated Hospital of Academy of Military Medical Sciences

Locations

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Affiliated Hospital of Academy of Military Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huisheng Ai, MD

Role: CONTACT

861066947135

Facility Contacts

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Huisheng Ai, MD

Role: primary

86-1066947126

Weidong Han, MD

Role: primary

86-13651392893

Other Identifiers

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CART-AML-2015

Identifier Type: -

Identifier Source: org_study_id

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