Clinical trial · Interventional
Retreatment With CTL019/CTL119
Retreatment With CTL019/CTL119 in Patients With Late Relapse of B-Cell Lymphomas
NCT04419909CI-TRIAL-00118926withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of Eligible Subjects
Summary
Brief summary (as posted)
This research study is designed to evaluate the effects of retreatment with CTL019/CTL119 in patients with late relapse of B-cell lymphomas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 redirected autologous T cells (CTL019 or CTL119 cells) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Retreatment with CTL019/CTL119
- description
- All subjects will receive retreatment with CTL019/CTL119 and be followed per the schedule of procedures.
- interventionNames
- Drug: CD19 redirected autologous T cells (CTL019 or CTL119 cells)
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- timeFrame
- At time of consent through 1 year after the subject received CTL019/CTL119
- description
- Safety of retreatment with CTL019/CTL119 as measured by treatment-related events
Secondary outcomes (1)
- measure
- Overall response rate using Cheson 2007 criteria
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+ 2. Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion 3. Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days) 4. No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to \< 2 year survival) with currently available therapies. 5. Age ≥18 years 6. Creatinine \< 1.6 mg/dL 7. ALT/AST \< 3x upper limit of normal 8. Bilirubin \< 2.0 mg/dL, unless subject has Gilbert's Syndrome (≤3.0 mg/dL) 9. 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. 10. Performance status (ECOG) 0 or 1. 11. Left Ventricle Ejection Fraction (LVEF) \> 40% confirmed by ECHO/MUGA 12. Agree to contraceptive requirements outlined in Section 4.3. 13. Provide written informed consent. Exclusion Criteria: 1. Uncontrolled active infection. 2. Active hepatitis B or hepatitis C infection. 3. Any uncontrolled active medical disorder that would preclude participation as outlined. 4. Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1). 5. HIV infection. 6. 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 7. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.
References
Publications (0)
Data not yet available
No reference posted for this study.