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

TriArm Therapeutics (Taiwan) Limited

Status and phase

Enrolling

Phase 1

Conditions

Acute Lymphoblastic Leukemia

Treatments

Biological: ARM011

Drug: Fludarabine

Drug: Cyclophosphamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT07066397

FIT-CD19-CAR-T-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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