A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL

Phase 1RecruitingNCT07066397

TriArm Therapeutics (Taiwan) Limited12 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Lymphoblastic Leukemia

Interventions

ARM011BIOLOGICAL

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

FludarabineDRUG

Administered prior to infusion of ARM011

CyclophosphamideDRUG

Administered prior to infusion of ARM011

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Group (ECOG) performance status ≤ 2. 6. Adequate organ functions 7. Life expectancy ≥12 weeks Key Exclusion Criteria: 1. Active central nervous system (CNS) involvement of ALL 2. Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis 3. Prior anti-CD19 therapy (other than blinatumomab) 4. Subjects who have experienced Grade 3 or higher cytokine release syndrome (CRS)/neurotoxicity following blinatumomab. 5. autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression within the last 2 years. 6. History or presence of cardiac or CNS disorders as defined in the protocol

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Incidence of adverse events [Safety and Tolerability]

Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities