Phase IIa Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRz and 4-Signaling Domains in Patients With Chemotherapy Relapsed or Refractory CD19+ Lymphomas
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pennsylvania
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects with CD19+ B cell lymphomas with no available curative treatment options (such as autologous or allogeneic SCT) who have a limited prognosis (several months to \<2 year survival) with currently available therapies will be enrolled. The study will enroll 51 evaluable subjects as follows:
CD19+ Lymphoma
Cohort A Subjects:
a. Follicular lymphoma, previously identified as CD19+ i. At least 2 prior chemotherapy or immunochemotherapy regimens (not including single agent monoclonal antibody therapy) ii. Patients who progress within 2 years after second or higher line of therapy will be eligible. For instance, patients who have progression of lymphoma \< 2 years after second or greater line therapy, but who have responded to their most recent treatment (3rd line or higher) will be eligible. Patients may have progression, stable disease or responding disease at the time of enrollment.
1. Have no active GVHD and require no immunosuppression
2. Are more than 6 months from transplant
You may not be if
Cohort B Subjects:
v. Patients with T cell/histiocyte-rich disease as confirmed by surgical pathology report
Cohort C Subjects:
Age ≥18 years
Creatinine \< 1.6 mg/dL
ALT/AST \< 3x upper limit of normal
Bilirubin \<2.0 mg/dL, unless subject has Gilbert's Syndrome (\<3.0 mg/dL)
Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy.
Performance status (ECOG) 0 or 1.
Left Ventricle Ejection Fraction (LVEF) \> 40% confirmed by ECHO/MUGA
Written informed consent is given. Successful T cell test expansion (first 10 subjects).
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 pregnancy test at enrollment. A urine pregnancy test will be 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. For additional details regarding use of steroids
Any uncontrolled active medical disorder that would preclude participation as outlined.
Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).
HIV infection.
Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \>4 weeks before enrollment
Patients in complete remission with no assessable disease.
Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.
Clareo Health | Phase IIa Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRz and 4-Signaling Domains in Patients With Chemotherapy Relapsed or Refractory CD19+ Lymphomas
