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

Lymphoma Clinical Trial

Official title:

CD19-directed Chimeric Antigen Receptor T Cells Therapy in Relapsed/Refractory B Cell Malignancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02537977
• Other study ID #: TJ1537
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2015
• Est. completion date: June 2020

Study information

• Verified date: November 2018
• Source: Shanghai Tongji Hospital, Tongji University School of Medicine
• Contact: Aibin Liang, MD,Ph.D.
• Phone: 0086-021-66111019
• Email: lab7182[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

Biological:
• CD19-directed CAR-T cells
CD19-directed CAR-T cell infusion will be given by vein

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine

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 the study.	2 years
Secondary	Response rates to CAR-T cells	Describe the response rates of patients treated with CAR-T cells, including complete remission, partial remission,stable disease and progression disease	2 years
Secondary	Progression free survival(PFS)		2 years
Secondary	Duration of remission(DOR)		2 years
Secondary	Overall survival(OS) of patients treated with CAR-T cells		2 years