Safety and Efficacy Evaluation of IM19 CAR-T Cells

Phase 1

• Conditions: Leukemia
• Interventions: Biological: IM19 CAR-T

• Registration Number: NCT03142646
• Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

Brief Summary

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-all.

Detailed Description

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-ALL patients and determine the MTD,LTD and the best dosage.

Study Timeline

• Study First Submitted: 2016-06-06
• Study Start: 2016-08-30
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-05
• Status Verified: 2017-10
• Last Update Submitted: 2018-04-28
• Last Update Posted: 2018-05-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with CD19+ leukemia, meeting the following criteria

  • At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)
  • Less than 1 year between last chemotherapy and progression
  • Not eligible or appropriate for allo-HSCT

• To be aged 4 to 65 years

• Estimated survival of ≥ 6 months, but ≤ 2 years

• ECOG score ≤2

• Relapse after auto-HSCT

• Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.

• Voluntary participation in the clinical trials and sign the informed consent.

Exclusion Criteria

• History of epilepsy or other CNS disease
• Patients have GVHD, which needs treatment with immunosuppressive agents
• Patients with prolonged QT interval or severe heart disease
• Patients in pregnancy or breast-feeding period
• Uncontrolled active infection
• Active hepatitis B or hepatitis C infection
• Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
• Previously treatment with any gene therapy products
• Feasibility assessment during screening demonstrates <30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation
• ALT /AST>3 x normal value; Creatinine> 2.5 mg/dl; Bilirubin >2.0 mg/dl
• Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
• HIV infection
• Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IM19 CART	IM19 CAR-T	A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of IM19CART cells administered intravenously.

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.

Secondary Outcome Measures

Name	Time	Method
Overall response rate	2 years	An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry

Trial Locations

Locations (2)

Beijing hospital; 🇨🇳 Beijing, China

Peking University People's Hospital (PKUPH); 🇨🇳 Peking, China