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

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.

Conditions

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

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Study Overview

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Study Details

Study 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.

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

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

Condition
Acute Myeloid Leukemia, in Relapse
Intervention / Treatment

-

Contacts and Locations

Charlotte

Novant Health Cancer Institute, Charlotte, North Carolina, United States, 28204

Winston Salem

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ARCE Therapeutics, Inc.,

Study Record Dates

2028-12