Safety and Efficacy Evaluation of IM23 CAR-T Cells (IM23CAR-T)

NCT ID: NCT03585517

Last Updated: 2023-01-19

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-21

Study Completion Date

2020-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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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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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.

Group Type EXPERIMENTAL

IM23

Intervention Type DRUG

T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor

Interventions

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IM23

T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Immunochina Medical Science & Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xian Lu

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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YMCART201806

Identifier Type: -

Identifier Source: org_study_id

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