Status:
UNKNOWN
Evaluation of 4th Generation Safety-designed CAR T Cells Targeting High-risk and Refractory B Cell Lymphomas
Lead Sponsor:
Peking University
Collaborating Sponsors:
University of Florida
Conditions:
B-cell Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02247609
Start Date
January 1 2014
End Date
October 1 2017
Last Update
October 20 2014
Active Locations (1)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142