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

Summary

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.

Eligibility

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

Conditions4

Locations3 sites

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