CD19-directed CAR T Cells Therapy in Relapsed/Refractory B Cell Malignancy

NCT ID: NCT02537977

Last Updated: 2018-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2020-06-30

Brief Summary

Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this clinical trial, the investigators aim to assess the safety and efficacy of administering T cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.

Detailed Description

Tongji Hospital of Tongji University has developed an investigational approach for treating patients with CD19 positive B cell malignancy that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with lentivirus to attack CD19 positive cells, and then giving the cells back to the patients.The main purpose of the study is to assess the safety and efficacy of the treatment with anti-CD19 CAR-T cells in the patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.

Conditions

Leukemia; Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR-T cells

Autologous 2nd generation CD19-directed CAR-T cells

Group Type: EXPERIMENTAL

CD19-directed CAR-T cells

Intervention Type: BIOLOGICAL

CD19-directed CAR-T cell infusion will be given by vein

Interventions

CD19-directed CAR-T cells

CD19-directed CAR-T cell infusion will be given by vein

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients with CD19+ leukemia or lymphoma, 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 6 to 85 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 <20% 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Aibin Liang，MD，Ph.D.

Director，Department of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aibin Liang, MD,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Tongji Hospital, Tongji University School of Medicine

Locations

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Aibin Liang, MD,Ph.D.

Role: CONTACT

lab7182@tongji.edu.cn

0086-021-66111019

Ping Li, MD,Ph.D.

Role: CONTACT

lilyforever76@126.com

0086-021-66111015

Facility Contacts

Aibin Liang, MD,Ph.D.

Role: primary

lab7182@tongji.edu.cn

0086-021-66111019

Other Identifiers

TJ1537

Identifier Type: -

Identifier Source: org_study_id