Actively Recruiting
A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
Led by TriArm Therapeutics (Taiwan) Limited · Updated on 2025-07-23
12
Participants Needed
1
Research Sites
819 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects age �3e�3d18 years
- Diagnosis of acute lymphoblastic leukemia (ALL)
- Disease that is refractory to or has relapsed after standard treatment and not suitable or unable to wait for other options
- Bone marrow with evidence of disease
- Eastern Cooperative Oncology Group (ECOG) performance status �3c�3d 2
- Adequate organ function
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Active central nervous system (CNS) involvement of ALL
- Diagnosis of Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis
- Prior anti-CD19 therapy other than blinatumomab
- History of Grade 3 or higher cytokine release syndrome or neurotoxicity after blinatumomab
- Autoimmune disease causing organ injury or needing systemic immunosuppression within the last 2 years
- History or presence of cardiac or CNS disorders as defined in the protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100229
Actively Recruiting
Research Team
R
Reta Ruan
CONTACT
Y
Yiming Gong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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