Clinical trial · Interventional
Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells
- 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)
Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.
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 |
|---|---|---|---|
| CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T cells
- description
- Targeting CD19
- interventionNames
- Biological: CAR-T cells
Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- 8 weeks
- description
- To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia
Secondary outcomes (1)
- measure
- Clinical responses to third generation CAR-T cells
- timeFrame
- 2 years
- description
- To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18-65 years * Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry * Refractory or relapsed B cell-acute lymphoblastic leukemia * No available curative treatment options (such as hematopoietic stem cell transplantation) * Stage III-IV disease * Creatinine \< 2.5 mg/dl * Aspartate transaminase-alanine transaminase ratio \< 3x normal * Bilirubin \< 2.0 mg/dl * Karnofsky performance status \>= 60 * Expected survival time \> 3 months * Adequate venous access for apheresis * Ability to understand and provide informed consent Exclusion Criteria: * Pregnant or lactating women * Patients requiring T cell immunosuppressive therapy * Active central nervous system leukemia * Any concurrent active malignancies * Patients with a history of a seizure disorder or cardiac disorder * Patients with human immunodeficiency virus, hepatitis B or C infection * Uncontrolled active infection
References
Publications (1)
- DERIVEDTang XY, Sun Y, Zhang A, Hu GL, Cao W, Wang DH, Zhang B, Chen H. Third-generation CD28/4-1BB chimeric antigen receptor T cells for chemotherapy relapsed or refractory acute lymphoblastic leukaemia: a non-randomised, open-label phase I trial protocol. BMJ Open. 2016 Dec 30;6(12):e013904. doi: 10.1136/bmjopen-2016-013904. PMID 28039295