Clinical trial · Interventional
Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation
- 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 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
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, in Relapse | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CARCIK-CD19 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CARCIK-CD19
- interventionNames
- Biological: CARCIK-CD19
Primary outcomes (1)
- measure
- Dose Limiting Toxicities (DLT):
- timeFrame
- 1 month
- description
- rate and severity of the cytokine release syndrome (CRS)
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-cell precursor ALL after HSCT; * Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry; * Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening; * No evidence of overall aGVHD \> Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days; * No longer taking immunosuppressive agents for at least 30 days prior to enrollment; Exclusion Criteria: * Patients with GVHD Grades II-IV; * Any cell therapy in the last 30 days;
References
Publications (1)
- DERIVEDMagnani CF, Gaipa G, Lussana F, Belotti D, Gritti G, Napolitano S, Matera G, Cabiati B, Buracchi C, Borleri G, Fazio G, Zaninelli S, Tettamanti S, Cesana S, Colombo V, Quaroni M, Cazzaniga G, Rovelli A, Biagi E, Galimberti S, Calabria A, Benedicenti F, Montini E, Ferrari S, Introna M, Balduzzi A, Valsecchi MG, Dastoli G, Rambaldi A, Biondi A. Sleeping Beauty-engineered CAR T cells achieve antileukemic activity without severe toxicities. J Clin Invest. 2020 Nov 2;130(11):6021-6033. doi: 10.1172/JCI138473. PMID 32780725