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

Phase 1

Completed

• Conditions: AML
• Interventions: Drug: IM23

• Registration Number: NCT03585517
• Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-01
• Study First Submitted QC: 2018-07-01
• Study First Posted: 2018-07-13
• Study Start: 2018-07-21
• Primary Completion: 2020-08-01
• Study Completion: 2020-10-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IM23 CART	IM23	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of study related adverse events	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

Trial Locations

Locations (1)

Xian Lu; 🇨🇳 Beijing, China