Allo CART-19 Protocol
Stopped early · Phase 1
Conditions studied: Acute Lymphocytic Leukemia
In brief
The primary objective is to determine the safety and survival of the redirected allogeneic T cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).
Key facts
- Study ID
- NCT01551043
- Run by
- University of Pennsylvania
- People needed
- 2
- Starts
- 2010-09-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2020-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- CD19+ ALL relapsed after allogeneic SCT.
- No active GVHD and off immunosuppression for greater than or equal to 4 weeks.
- Age greater than or equal to 18 years.
- Creatinine less than or equal to2.5 mg/dl.
- ALT/AST less than or equal to3x normal
- Bilirubin less than or equal to2.0 mg/dl
- Donor is available and is able to undergo apheresis. A separate donor consent process and form is described below.
- Voluntary informed consent is given.
You may not qualify if…
- Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene therapy products.
- Feasibility assessment during screening demonstrates less than 30% transduction of target lymphocytes, or insufficient expansion ( less than 5-fold) in response to CD3/CD28 costimulation..
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
- Patients with active CNS involvement with leukemia. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was greater than or equal to 4 weeks before enrollment
- Patients with active GVHD or requiring immune suppression.
Where it is running
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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