A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
Recruiting
Phase 1
Interventional Study
Acute Lymphoblastic Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 12 (estimated)
- Sponsor
- TriArm Therapeutics (Taiwan) Limited · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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…
Contacts