Clinical trial · Interventional
A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
A Phase 1 Study of Fast-In-Time Autologous Anti-CD19 Chimeric Antigen Receptor T Cells (FIT-CD19-CAR-T Cells) Infusion for Subjects With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
NCT07066397CI-TRIAL-00092522recruitingPhase 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)
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.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARM011 | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ARM011 following lymphodepleting chemotherapy
- description
- A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011
- interventionNames
- Biological: ARM011
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Incidence of adverse events [Safety and Tolerability]
- timeFrame
- Up to 24 months after ARM011 infusion
- description
- Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
Secondary outcomes (5)
- measure
- Evaluate cellular kinetics and persistence of ARM011
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Male or female subjects age ≥18 years 2. Diagnosis of ALL 3. Refractory to or relapsed after current standard treatment, and not suitable or unable to wait for other treatment options 4. Disease burden: Bone marrow with evidence of disease. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 6. Adequate organ functions 7. Life expectancy ≥12 weeks Key Exclusion Criteria: 1. Active central nervous system (CNS) involvement of ALL 2. Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis 3. Prior anti-CD19 therapy (other than blinatumomab) 4. Subjects who have experienced Grade 3 or higher cytokine release syndrome (CRS)/neurotoxicity following blinatumomab. 5. autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression within the last 2 years. 6. History or presence of cardiac or CNS disorders as defined in the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.