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

• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03585517
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 27.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
AML	Drug: IM23	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy Evaluation of IM23 CAR-T Cells On CD123+ AML Patients
• Anticipated Study Start Date: Jul 21, 2018
• Anticipated Primary Completion Date: Aug 1, 2020
• Anticipated Study Completion Date: Nov 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xian Lu	Beijing		China

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing Immunochina Medical Science & Technology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03585517
• Other Study ID Numbers: YMCART201806
• First Posted: Jul 13, 2018
• Last Update Posted: Jul 16, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 16, 2018