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

Not Applicable

Recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Biological: ARM011; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT07066397
• Lead Sponsor: TriArm Therapeutics (Taiwan) Limited

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.

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 Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-04
• Study First Submitted QC: 2025-07-04
• Study Start: 2025-07-15
• Study First Posted: 2025-07-15
• Last Update Submitted: 2025-07-20
• Last Update Posted: 2025-07-23
• Primary Completion: 2028-04-01
• Study Completion: 2041-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARM011 following lymphodepleting chemotherapy	ARM011	A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011
ARM011 following lymphodepleting chemotherapy	Fludarabine	A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011
ARM011 following lymphodepleting chemotherapy	Cyclophosphamide	A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events [Safety and Tolerability]	Up to 24 months after ARM011 infusion	Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities

Secondary Outcome Measures

Name	Time	Method
Evaluate cellular kinetics and persistence of ARM011	Up to 24 months after ARM011 infusion	Area under the concentration time curve (AUC) in peripheral blood
Evaluate preliminary anti-tumor activity of ARM011	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)
Evaluate host immunogenicity to ARM011	Up to 24 months after ARM011 infusion	Incidence of anti-CD19-directed CAR antibodies
Evaluate the feasibility of administration of ARM011	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).

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan