NCT07066397

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
181mo left

Started Jul 2025

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jul 2025Apr 2041

First Submitted

Initial submission to the registry

July 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2041

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

July 4, 2025

Last Update Submit

July 20, 2025

Conditions

Acute Lymphoblastic Leukemia

Keywords

CAR T-Cell TherapyAcute lymphoblastic leukemiaCD19non-viralfast CAR

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events [Safety and Tolerability]

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

    Up to 24 months after ARM011 infusion

Secondary Outcomes (5)

  • Evaluate cellular kinetics and persistence of ARM011

    Up to 24 months after ARM011 infusion

  • Evaluate cellular kinetics and persistence of ARM011

    Up to 24 months after ARM011 infusion

  • Evaluate preliminary anti-tumor activity of ARM011

    Up to 24 months after ARM011 infusion

  • Evaluate host immunogenicity to ARM011

    Up to 24 months after ARM011 infusion

  • Evaluate the feasibility of administration of ARM011

    24 months

Study Arms (1)

ARM011 following lymphodepleting chemotherapy

EXPERIMENTAL

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011

Biological: ARM011Drug: FludarabineDrug: Cyclophosphamide

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

ARM011 following lymphodepleting chemotherapy
FludarabineDRUG

Administered prior to infusion of ARM011

ARM011 following lymphodepleting chemotherapy
CyclophosphamideDRUG

Administered prior to infusion of ARM011

ARM011 following lymphodepleting chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100229, Taiwan

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Hosein Kouros-Mehr, MD, PhD

    TriArm Inc.

    STUDY DIRECTOR

Central Study Contacts

Reta Ruan

CONTACT

+86 13641883361reta@triarm.com

Yiming Gong, MD

CONTACT

+86 15221835460yiming.gong@triarmbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 15, 2025

Study Start

July 15, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2041

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)