Chimeric Antigen Receptor T Cells (CART) Therapy in Refractory/Relapsed B Cell Hematologic Malignancies

NCT ID: NCT02813837

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2021-07-31

Brief Summary

This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy.

Detailed Description

This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy. When patients enroll in this trial, autologous CD19CART cells were generated from the mononuclear cells of the patient's peripheral blood (PB). During the term of cell preparation of CD19CART cells, patients will receive a conditioning regimen. One day after completing conditioning regimen, the patient will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.

Conditions

Leukemia, B-Cell; Lymphoma, B-Cell

Study Design

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

Study Groups

single arm

Experimental: CD19 CART cell.The target dose range administered in this study is 1x10e5-1x10e7 CART-19 cells/kg.

Group Type: EXPERIMENTAL

CD19CART

Intervention Type: BIOLOGICAL

Patients will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. The target dose range administered in this study is 1x10e5-1x10e7 CD19CART cells/kg. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.

Interventions

CD19CART

Patients will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. The target dose range administered in this study is 1x10e5-1x10e7 CD19CART cells/kg. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.

Intervention Type: BIOLOGICAL

Other Intervention Names

CD19-directed chimeric antigen receptor modified T cells

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed as CD19 positive refractory and relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL),chronic lymphocytic leukemia(CLL),non-Hodgkin's lymphoma(NHL)
• not eligible or appropriate for auto-HSCT or allo-HSCT or relapsed after hematopoietic stem cell transplant(HSCT)
• At least one measurable lesion defined as one lesion larger than 1.5cm or two lesion more than 1.0cm(for patients with NHL )
• Age ≤60 years
• Eastern Cooperative Oncology Group(ECOG) Performance status 0 to 2, Expected survival > 6 months
• Left Ventricular Ejection Fraction (LVEF) > 50%
• no history of other malignancies;
• no other serious diseases which conflict with the treatment in the present trial
• All patients should consent to adopt efficient contraception methods during the treatment and after the treatment. The pregnant tests of women who are in child bearing period should be negative before the treatment.
• patients should understand and are willing to participate in the trial. Inform consent form is supposed to obtained before treatment

Exclusion Criteria

• Diagnosis or classification undefined
• Those with primary central nervous system lymphoma or testicular leukaemia or lymphoma
• Patients with a known history or prior diagnosis of epilepsia or other disease affecting the central nervous system, or serious mental diseases;
• Patients who have secondary leukaemia or lymphoma after chemotherapy or radiotherapy for other malignancies
• Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy, concurrent use of immunosuppressant medications
• Class III/IV cardiovascular disability according to the New York Heart Association Classification
• Pregnant or lactating women(the safety of this therapy on unborn children is not known)
• With active infection
• Active hepatitis B, hepatitis C or syphilis infection
• Patients use of systemic steroids within 2 weeks. Recent or current use of inhaled steroids is not exclusionary
• Prior treatment with gene therapy product
• Cluster of differentiation 3(CD3) positive cells<0.9x10^4/ml in peripheral blood (PB)
• Organ function meeting following criteria: liver and renal function: alanine aminotransferase(ALT)/aspartate aminotransferase(AST) > 3 times the upper limit of normal, or bilirubin>2.0 mg/dl（34.2umol/L）, or creatinine >2.5mg/dl（221.0umol/L） ; hematopoietic function:Neutrophil count<1.0x10^9/L，hemoglobin<80g/L，platelet <50x10^9/L(for patients with NHL )
• Any uncontrolled active medical disorder that would preclude participation as outlined
• HIV infection
• The researchers considered unsuitable to participate in this clinical study.
• Patients with poor compliance

• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovative Cellular Therapeutics Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu Hu, Ph.D

Role: STUDY_DIRECTOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

He Huang, Ph.D

Role: STUDY_DIRECTOR

The First Affiliated Hospital of the College of Medicine, Zhejiang University

Locations

Innovative Cellular Therapeutics CO., LTD.

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Xiao, Ph.D

Role: CONTACT

+86-21-58950719

Facility Contacts

Lei Xiao, Ph.D

Role: primary

+86-21-58950719

Other Identifiers

SCT019-01

Identifier Type: -

Identifier Source: org_study_id