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

July 20, 2025 updated by: TriArm Therapeutics (Taiwan) Limited

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100229
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Shangju Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM011 following lymphodepleting chemotherapy
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 months after ARM011 infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate cellular kinetics and persistence of ARM011
Time Frame: Up to 24 months after ARM011 infusion
Cellular kinetics related peak (Cmax) in peripheral blood
Up to 24 months after ARM011 infusion
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
Up to 24 months after ARM011 infusion
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)
Up to 24 months after ARM011 infusion
Evaluate host immunogenicity to ARM011
Time Frame: Up to 24 months after ARM011 infusion
Incidence of anti-CD19-directed CAR antibodies
Up to 24 months after ARM011 infusion
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).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriArm Therapeutics (Taiwan) Limited

Investigators

  • Study Director: Hosein Kouros-Mehr, MD, PhD, TriArm Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2041

Study Registration Dates

First Submitted

July 4, 2025

First Submitted That Met QC Criteria

July 4, 2025

First Posted (Actual)

July 15, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 20, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIT-CD19-CAR-T-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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