drugset / Trial / NCT07066397
A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1 study to evaluate FIT-CD19-CAR-T (ARM011) safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Timeline
- Start
- 2025-07-15
- Primary completion
- 2028-04-01
- Completion
- 2041-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARM011 | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |