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

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

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

Study Overview

• Status: Completed
• Conditions: AML
• Intervention / Treatment: Drug: IM23

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xian Lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: IM23; T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of study related adverse events	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	2 years

Collaborators and Investigators

• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2018
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: July 1, 2018
• First Submitted That Met QC Criteria: July 1, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: YMCART201806

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No