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

Beijing Immunochina Medical Science & Technology

Status and phase: Completed; Phase 1

Conditions: AML

Treatments: Drug: IM23

Study type: Interventional

Funder types: Industry

Identifiers

NCT03585517

YMCART201806

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 3 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

IM23 CART

Experimental group

Description:

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.

Treatment:

Drug: IM23