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

Lymphoma, B-Cell Clinical Trial

Official title:

A Multicenter Efficacy and Safety Study of Cluster of Differentiation 19 (CD19)-Targeted CART (CD19CART) Therapy for CD19 Positive Relapsed or Refractory B-cell Hematologic Malignancies (SCT019-01）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02813837
• Other study ID #: SCT019-01
• Status: Recruiting
• Phase: N/A
• First received: June 19, 2016
• Last updated: June 26, 2016
• Start date: June 2015
• Est. completion date: July 2021

Study information

• Verified date: June 2016
• Source: Innovative Cellular Therapeutics Co., Ltd.
• Contact: Lei Xiao, Ph.D
• Phone: +86-21-58950719
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Hubei ProvinceChina: Health and Family Planning Commission of Zhejiang Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, B-Cell
• Lymphoma, B-Cell

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
China	Innovative Cellular Therapeutics CO., LTD.	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Cellular Therapeutics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of study related adverse events		up to 12 months	Yes
Secondary	Anti-leukemia or lymphoma responses to CD19CART cell infusions		up to 24 weeks	Yes