Status:
NOT_YET_RECRUITING
Retreatment With CTL019/CTL119
Lead Sponsor:
University of Pennsylvania
Conditions:
Lymphoma, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This research study is designed to evaluate the effects of retreatment with CTL019/CTL119 in patients with late relapse of B-cell lymphomas.
Detailed Description
This is a single arm open label trial that will assess the safety and efficacy of retreatment with CTL019/CTL119 chimeric antigen receptor (CAR) modified T cells in patients who have late relapse of d...
Eligibility Criteria
Inclusion
- Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+
- Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion
- Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days)
- No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to \< 2 year survival) with currently available therapies.
- 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)
- Measurable or assessable disease according to the "Revised Response Criteria for Malignant Lymphoma" (Cheson et al., J. Clin. Onc., 2007)88. Patients in complete remission with no evidence of disease are not eligible.
- Performance status (ECOG) 0 or 1.
- Left Ventricle Ejection Fraction (LVEF) \> 40% confirmed by ECHO/MUGA
- Agree to contraceptive requirements outlined in Section 4.3.
- Provide written informed consent.
Exclusion
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- 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 with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.
Key Trial Info
Start Date :
May 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04419909
Start Date
May 1 2026
End Date
July 1 2028
Last Update
July 2 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104