Actively Recruiting
A Phase 1 Study of Fast-In-Time Autologous Anti-CD19 CAR T Cells for Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Led by TriArm Therapeutics (Taiwan) Limited · Updated on 2025-07-23
12
Participants Needed
1
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of FIT-CD19-CAR-T (ARM011) cells in adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). This Phase 1, open-label study also looks at the anti-tumor activity, cell behavior, immune response, and exploratory biomarkers of the investigational treatment. ARM011 is given after a standard lymphodepleting chemotherapy regimen to prepare the body for the infusion. Participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by an intravenous infusion of ARM011, an autologous CAR T-cell product made using a rapid manufacturing process. This dose-finding study uses a 3+3 design to determine safety and appropriate dosing. The treatment period includes monitoring for up to 24 months after the ARM011 infusion. Throughout the study, participants will be closely monitored for adverse events, cellular kinetics, persistence of ARM011 cells, immune responses, and preliminary anti-tumor effects. Assessments include clinical evaluations and laboratory tests over a follow-up period of up to two years. The study aims to evaluate both safety and feasibility of this investigational treatment.
CONDITIONS
Brief 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 618 years
- Diagnosis of acute lymphoblastic leukemia (ALL)
- Relapsed or refractory to current standard treatment and unable or not suitable to wait for other treatments
- Bone marrow showing evidence of disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate organ function
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Active involvement of the central nervous system (CNS) by acute lymphoblastic leukemia
- Diagnosis of Burkitt's lymphoma or chronic myeloid leukemia lymphoid blast crisis
- Prior anti-CD19 therapy except for blinatumomab
- History of Grade 3 or higher cytokine release syndrome or neurotoxicity after blinatumomab treatment
- Autoimmune disease causing organ injury or requiring systemic immunosuppression within the last 2 years
- History or presence of cardiac or central nervous system disorders as defined in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Several days
Participants receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide prior to CAR T-cell infusion.
Daily visits for chemotherapy administration
Duration - Single infusion followed by active monitoring
Participants receive an intravenous infusion of ARM011, an autologous CD19-targeted CAR T-cell product.
1 infusion visit plus frequent follow-up visits during initial treatment period
Duration - Up to 24 months
Participants are monitored for safety, tolerability, and treatment effects for up to 24 months after ARM011 infusion.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100229
Actively Recruiting
Research Team
R
Reta Ruan
Y
Yiming Gong, MD
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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