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Trial Title:
Evaluation of 4th Generation Safety-designed CAR T Cells Targeting High-risk and Refractory B Cell Lymphomas
NCT ID:
NCT02247609
Condition:
B-cell Lymphomas
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Conditions: Keywords:
B cell lymphoma
non-Hodgkin's lymphoma
Burkitt lymphoma
diffused large B cell lymphoma
B cell malignancy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
Anti-CD19 CAR T cells
Description:
Autologous 4th generation withdrawable lentiviral-transduced anti-CD19-CAR T cells
Arm group label:
CAR T cells
Other name:
19273-4SCAR
Summary:
Currently, a majority of B cell lymphomas cannot be cured by standard chemo-radiotherapy.
Most B cell lymphomas express cluster of differentiation antigen 19 (CD19), which
represents a very attractive target for chimeric antigen receptor (CAR)-based immune cell
therapy. This study will evaluate a novel 4th generation CD19 CAR engineered with a
self-withdrawal mechanism (19273-4SCAR) for both efficacy and safety in lymphoma
patients.
Detailed description:
CD19 single chain antibody-based chimeric antigen receptor (CAR)-engineered T cells have
demonstrated great clinical potential in treating chronic and acute B cell leukemias. B
cell lymphomas, similar to B cell leukemias, express CD19 surface molecules, and the
majority of the B cell lymphoma patients cannot be cured by standard chemo-radiotherapy.
CD19 CAR-based adoptive T cell therapy is associated with an unwanted adverse effect, the
loss of CD19 B cells, which results in humoral immune deficiency. This study will
evaluate a novel 4th generation CD19 CAR engineered with a self-withdrawal genetic
mechanism (19273-4SCAR) for both efficacy and safety in lymphoma patients. The 4th
generation design of the CAR incorporates the intracellular signaling domain of cluster
of differentiation antigen 27 (CD27), known to be associated with T cell activation,
survival and longevity. The inducible caspase 9 self-withdrawal design allows for rapid
elimination of the infused CAR T cells upon complete eradication of the tumor cells,
which will be followed by the recovery of humoral immunity. Patients receiving the
19273-4SCAR T cells will be closely monitored for infusion response, tumor eradication
effect, longevity of the CAR T cells, and the recovery of B cell functions after
withdrawal of the CAR T cells.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Relapsed or refractory CD19(+) B cell lymphoma patients proved by
immuno-histochemistry (IHC) or Flow-cytometry.
- Not eligible for autologous stem-cell transplantation (ASCT) or relapsed after ASCT.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Age≥18.
- Pulse oximetry of > 90% on room air.
- Adequate hepatic function, defined as alanine transaminase (ALT) <3 x upper limit of
normal (ULN), aspartate aminotransferase (AST) <3 x ULN; serum bilirubin and
alkaline phosphatase <2 x ULN.
- Adequate renal function, defined as serum creatinine <2.0mg/dl.
- Adequate heart function with LVEF≥50%
- Hb≥80g/L
- Measurable disease can be identified.
- Life expectancy ≥3 months.
- Sexually active patients must be willing to utilize one of the more effective birth
control methods during the study and for 1 year after the study is concluded. The
male partner should use a condom.
- Patients must sign an informed consent.
Exclusion Criteria:
- Uncontrolled active infection.
- Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV).
- HIV positive
- Pregnant or lactating.
- Currently enrolled in another clinical trial.
- Concurrent use of systemic steroids.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhu, MD
Phone:
+86-10-88196596
Email:
zj@bjcancer.org
Investigator:
Last name:
Jun Zhu, MD
Email:
Principal Investigator
Start date:
January 2014
Completion date:
October 2017
Lead sponsor:
Agency:
Peking University
Agency class:
Other
Collaborator:
Agency:
University of Florida
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02247609
