RECRUITING

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

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Conditions

Acute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia RefractoryMDS (Myelodysplastic Syndrome)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-05
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06680752

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts
  2. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  3. * Adequate hematologic status:
  4. * Absolute lymphocyte count (ALC) \> 100/mm3
  5. * Adequate renal, hepatic, cardiac and pulmonary function:
  6. * ALT and AST \< 3.0 × the ULN
  7. * Creatinine clearance ≥ 45.0 mL/min as estimated by Cockcroft-Gault and independent dialysis
  8. * Total bilirubin ≤ 2.0 mg/dL
  9. * Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test
  10. * Contraception: males and females of childbearing potential must agree to use an effective method of contraception
  11. * Participant is capable of giving signed informed consent
  1. * Participants with acute promyelocytic leukemia
  2. * Presence of active and clinically relevant central nervous system (CNS) disorder
  3. * Autoimmune disease requiring immunosuppressive treatment
  4. * Participants with known hepatic bridging cirrhosis
  5. * Currently active infection with hepatitis B or C
  6. * Previous treatment with investigational gene or cell therapy (including CAR therapy)
  7. * Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)
  8. * 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

Contacts and Locations

Study Contact

ARCE Therapeutics, Inc
CONTACT
+886-2-26581868
contact@arcetherapeutics.com

Study Locations (Sites)

Novant Health Cancer Institute
Charlotte, North Carolina, 28204
United States
Novant Health Cancer Institute
Winston Salem, North Carolina, 27201
United States

Collaborators and Investigators

Sponsor: ARCE Therapeutics, 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 Registration Dates

Study Start Date2025-05
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-05
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia, in Relapse
  • Acute Myeloid Leukemia Refractory
  • MDS (Myelodysplastic Syndrome)