Clinical trial · Interventional
Allo CART-19 Protocol
Pilot Study of Donor Lymphocyte Infusions Using Donor T Cells Engineered to Contain Anti-CD19 Attached To TCR And 4-1BB Signaling Domains in Patients With Relapsed CD19+ All After Allogeneic Stem Cell Transplantation
NCT01551043CI-TRIAL-00045876terminatedPhase 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): Administrative Reasons
Summary
Brief summary (as posted)
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).
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 |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART-19 | Biological | Tisagenlecleucel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Biological: CART-19
Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- 26 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.