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

NCT02813837 | Unknown DMC

• 1 other identifier: SCT019-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, B-Cell; Lymphoma, B-Cell

Keywords

relapsed; refractory; CD19+; leukemia; lymphoma

Outcome Measures

Primary Outcomes (1)

• Occurrence of study related adverse events

  up to 12 months

Secondary Outcomes (1)

• Anti-leukemia or lymphoma responses to CD19CART cell infusions

  up to 24 weeks

Study Arms (1)

single arm

EXPERIMENTAL

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

Biological: CD19CART

Interventions

CD19CART 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.

Also known as: CD19-directed chimeric antigen receptor modified T cells

single arm

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Innovative Cellular Therapeutics Co., Ltd.: lead

Study Sites (1)

Innovative Cellular Therapeutics CO., LTD.

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Leukemia, B-Cell; Lymphoma, B-Cell; Recurrence; Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yu Hu, Ph.D

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

  STUDY DIRECTOR

• He Huang, Ph.D

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

  STUDY DIRECTOR

Central Study Contacts

Lei Xiao, Ph.D

CONTACT

+86-21-58950719

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: June 27, 2016
• Study Start: June 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

CN (1)