RightFit
RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (3)

NC

TX