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OpenTrials
Completed

NCT Number: NCT03585517

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

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

Completed

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Key information

Conditions

AML

Age range

3 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xian Lu

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IM23

Drug

T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor

Primary outcomes

  1. Occurrence of study related adverse events

    Time frame: 2 years

    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 2

Sponsors and collaborators

Lead sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Industry

Registry information

Official study title

Safety and Efficacy Evaluation of IM23 CAR-T Cells On CD123+ AML Patients

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2018
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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