NCT07066397RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 4 Jul 2025
- Start date
- 15 Jul 2025
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- TriArm Therapeutics (Taiwan) Limited
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07066397
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 15 Jul 2025 to the primary completion date, 1 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior anti-CD19 therapy (other than blinatumomab)
Other illness
- Subjects who have experienced Grade 3 or higher cytokine release syndrome (CRS)/neurotoxicity following blinatumomab.
- autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression within the last 2 years.
- History or presence of cardiac or CNS disorders as defined in the protocol
Other
- Active central nervous system (CNS) involvement of ALL
- Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis
Who the study is looking for
- Male or female subjects age ≥18 years
- Diagnosis of ALL
- Refractory to or relapsed after current standard treatment, and not suitable or unable to wait for other treatment options
- Disease burden: Bone marrow with evidence of disease.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Adequate organ functions
- Life expectancy ≥12 weeks
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.