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

AML Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585517
• Other study ID #: YMCART201806
• Status: Completed
• Phase: Phase 1
• Start date: July 21, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: July 2018
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• AML

Intervention

Drug:
• IM23
T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor

Locations

Country	Name	City	State
China	Xian Lu	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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