A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARM011, Fludarabine, Cyclophosphamide.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
This is an open-label, single arm, Phase 1 study to evaluate the safety and tolerability of FIT-CD19-CAR-T (ARM011) administered intravenously (IV) following a standard lymphodepleting (LD) chemotherapy regimen of cyclophosphamide and fludarabine in subjects with relapsed/refractory acute lymphoblastic leukemia (ALL). This dose finding study will use a 3+3 design.
Interventions
- Biological ARM011
ARM011 is an autologous, CD19 targeted CAR T-cell product developed on fast-in-time (FIT) platform-a non-viral, 2-day rapid manufacturing process - Drug Fludarabine
Administered prior to infusion of ARM011 - Drug Cyclophosphamide
Administered prior to infusion of ARM011
Primary outcome measures
- Incidence of adverse events [Safety and Tolerability] [Time frame: Up to 24 months after ARM011 infusion]
Secondary outcome measures (5)
- Evaluate cellular kinetics and persistence of ARM011 [Time frame: Up to 24 months after ARM011 infusion]
- Evaluate cellular kinetics and persistence of ARM011 [Time frame: Up to 24 months after ARM011 infusion]
- Evaluate preliminary anti-tumor activity of ARM011 [Time frame: Up to 24 months after ARM011 infusion]
- Evaluate host immunogenicity to ARM011 [Time frame: Up to 24 months after ARM011 infusion]
- Evaluate the feasibility of administration of ARM011 [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Active central nervous system (CNS) involvement of ALL
- Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis
- Prior anti-CD19 therapy (other than blinatumomab)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT07066397 · FIT-CD19-CAR-T-003