Clinical trial · Interventional
Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL
Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19
NCT02799550CI-TRIAL-00037266unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic CART-19 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- allogeneic CART-19
- description
- infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
- interventionNames
- Biological: allogeneic CART-19
Primary outcomes (1)
- measure
- Occurrence of study related adverse events
- timeFrame
- 1 year
- description
- defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria
Secondary outcomes (3)
- measure
- Overall response rate of allogeneic CART-19
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 60 years * Patient with relapsed and/or refractory CD19 positive B-cell acute lymphoblastic leukemia (B-ALL) * Estimated life expectancy ≥ 12 weeks (according to investigator's judgment) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria: * Previous treatment with investigational gene or cell therapy medicine products * CD19 negative B-cell leukemia * Any uncontrolled active medical disorder that would preclude participation as outlined
References
Publications (1)
- DERIVEDCai B, Guo M, Wang Y, Zhang Y, Yang J, Guo Y, Dai H, Yu C, Sun Q, Qiao J, Hu K, Zuo H, Dong Z, Zhang Z, Feng M, Li B, Sun Y, Liu T, Liu Z, Wang Y, Huang Y, Yao B, Han W, Ai H. Co-infusion of haplo-identical CD19-chimeric antigen receptor T cells and stem cells achieved full donor engraftment in refractory acute lymphoblastic leukemia. J Hematol Oncol. 2016 Nov 25;9(1):131. doi: 10.1186/s13045-016-0357-z. PMID 27887660