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NCT Number: NCT07066397

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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Taiwan University Hospital

Taipei, 100229, Taiwan

Location status: Recruiting

Location contact

Shangju Wu

CONTACT

[email protected]

+886 0972-652-039

Shangju Wu

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARM011

Biological

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

Fludarabine

Drug

Administered prior to infusion of ARM011

Cyclophosphamide

Drug

Administered prior to infusion of ARM011

Primary outcomes

  1. Incidence of adverse events [Safety and Tolerability]

    Time frame: Up to 24 months after ARM011 infusion

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

Secondary outcomes

  1. Evaluate cellular kinetics and persistence of ARM011

    Time frame: Up to 24 months after ARM011 infusion

    Cellular kinetics related peak (Cmax) in peripheral blood

  2. Evaluate cellular kinetics and persistence of ARM011

    Time frame: Up to 24 months after ARM011 infusion

    Area under the concentration time curve (AUC) in peripheral blood

  3. Evaluate preliminary anti-tumor activity of ARM011

    Time frame: Up to 24 months after ARM011 infusion

    Preliminary anti-tumor activity: Proportion of subjects with an objective response (including complete response or complete remission with incomplete count recovery)

  4. Evaluate host immunogenicity to ARM011

    Time frame: Up to 24 months after ARM011 infusion

    Incidence of anti-CD19-directed CAR antibodies

  5. Evaluate the feasibility of administration of ARM011

    Time frame: 24 months

    The proportion of subjects for whom a CAR T-cell product meeting specifications could be prepared, which will be computed with a corresponding 95% confidence interval (CI).

Study contacts

Contact information is provided by the study sponsor or research team.

Reta Ruan

CONTACT

[email protected]

+86 13641883361

Yiming Gong, MD

CONTACT

[email protected]

+86 15221835460

Sponsors and collaborators

Lead sponsor

TriArm Therapeutics (Taiwan) Limited

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2041
First posted
Jul 15, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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