Status and phase
Conditions
Treatments
About
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells.
PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to chemotherapy.
Full description
PRIMARY OBJECTIVES:
To assess the efficacy of TanCAR19/20 T cells in relapsed or refractory NHL, defined as overall response rate (ORR).
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of TanCAR19/20 T cells. II. To evaluate time to response (TTR), duration of overall response (DOR), progression free survival (PFS) and overall survival (OS).
III. To determine in vivo expansion and persistence of TanCAR19/20 T cells.
OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive anti-CD19/20-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on day1 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 3 years.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Patients eligible for inclusion in this study have to meet all of the following criteria:
Age ≥18 and ≤70 years.
Performance status (ECOG) between 0 and 2.
Histologically confirmed CD20+ and/or CD19+ B-cell non-Hodgkin lymphoma (NHL), including the following types defined by WHO 2008:
Refractory disease or relapsed after treatment with ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous HSCT or being ineligible for or not consenting to autologous HSCT.
We defined chemotherapy-refractory disease as meeting one or more of the following criteria:
Failure following autologous HSCT was defined as follows:
PD or relapse ≥3 months after treatment with a targeted CD19 therapy, including CD19-CAR T cells or anti-CD19/anti-CD3.
Successful leukapheresis assessment and pre-culture of T cells.
Life expectancy > 3 months.
Adequate organ function:
An adequate bone marrow reserve defined as:
Measurable or assessable disease according to the "IWG Response Criteria for Malignant Lymphoma" (Cheson 2007). Patients in CR with no evidence of disease were not eligible.
Informed consent/assent requiring that all patients have the ability to understand and the willingness to provide written informed consent.
Exclusion Criteria:
Patients eligible for this study must not meet any of the following criteria:
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal