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Recruiting NCT06680752

Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS

Phase I / Phase II Interventional Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory MDS (Myelodysplastic Syndrome)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARD103, Cyclophosphamide, Fludarabine.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, MDS (Myelodysplastic Syndrome). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Overview

This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

Detailed description

The investigational product (IP) for this study is ARD103, a C-type lectin-like molecule-1 (CLL-1) autologous chimeric antigen receptor T-cells (CAR-T). CLL-1 is highly expressed on both myeloid blasts and leukemia stem cells (LSCs) but is absent on normal hematopoietic stem cells (HSCs), suggesting CLL-1 as an excellent therapeutic target for AML and hence other potential myeloid malignancies.

Interventions

  • Biological ARD103
    ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion
  • Drug Cyclophosphamide
    iv administration for lymphodepletion
  • Drug Fludarabine
    iv administration for lymphodepletion

Primary outcome measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: 28 days post ARD103 infusion]
  • To determine the RP2D of ARD103 [Time frame: 28 days post ARD103 infusion]
  • To evaluate overall response rate (ORR) [Time frame: Up to 24 months]
Secondary outcome measures (3)
  • Overall Survival (OS) [Time frame: First infusion date of ARD103 up to 15 years]
  • Progression-free survival (PFS) [Time frame: Up to 24 months]
  • Time to best response [Time frame: First infusion date of ARD103 up to 24 months]

Eligibility criteria

Inclusion criteria

  • Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic status:
  • Absolute lymphocyte count (ALC) > 100/mm3
  • Adequate renal, hepatic, cardiac and pulmonary function:
  • ALT and AST < 3.0 × the ULN
  • Creatinine clearance ≥ 45.0 mL/min as estimated by Cockcroft-Gault and independent dialysis
  • Total bilirubin ≤ 2.0 mg/dL
  • Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test
  • Contraception: males and females of childbearing potential must agree to use an effective method of contraception
  • Participant is capable of giving signed informed consent

Exclusion criteria

  • Participants with acute promyelocytic leukemia
  • Presence of active and clinically relevant central nervous system (CNS) disorder
  • Autoimmune disease requiring immunosuppressive treatment
  • Participants with known hepatic bridging cirrhosis
  • Currently active infection with hepatitis B or C
  • Previous treatment with investigational gene or cell therapy (including CAR therapy)
  • Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)
  • Previous chemotherapy including biologic/targeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Novant Health Cancer Institute — Charlotte
  • Novant Health Cancer Institute — Winston-Salem
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06680752 · ARD103_ARCE-CL-P-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗