Clinical trial · Interventional
Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL
Measurable Residual Disease Driven Strategy for One or Two Infusions of Non- Viral, Transposon-manipulated CARCIK (CD19) Cells: A Phase II Study in Pediatric and Adult Patients With Relapsed/Refractory B Cell Precursor ALL (BCP-ALL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single arm, open-label, multi-center, phase II study to determine the activity and the safety of a therapeutic strategy that allows a second CARCIK-CD19 cells infusion, driven by the status of disease from one month after the first infusion, in adult and pediatric patients with r/r BCP- ALL.
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 Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTG-CARCIK-CD19 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CARCIK-CD19
- interventionNames
- Genetic: PTG-CARCIK-CD19
Primary outcomes (6)
- measure
- To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
- timeFrame
- Baseline and day 28
- description
- At baseline and at Day 28 after infusion: lymphoblasts \< 5% at morphological evaluation of bone marrow aspirate
- measure
- To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
- timeFrame
- Baseline and day 28
- description
- At baseline and at Day 28 after infusion: lymphoblasts \< 5% at flow cytometry bone marrow evaluation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Children (1-17) and adults (18-75 years old); * Relapsed or refractory adult and pediatric B- ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if \<5%, with at least 1% of molecular disease at PCR; * Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry; * Diagnosis of CD19 positive ALL in the bone marrow, and/or peripheral blood and/or extramedullary sites with the exclusion of Central Nervous System (CNS) if CNS-3 disease. Exclusion Criteria: * GVHD Grades II-IV for patients who had previously been transplanted; 2. Any cell therapy in the previous 30 days; * Patient with concomitant life-threatening infectious disease; * Lansky/Karnofsky score \<60; * Patients with hepatic or renal disease as specific above; * Pregnant or breast-feeding females; * Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
References
Publications (0)
Data not yet available