Treatment with ARD103 CAR-T therapy for patients with relapsed or refractory AML or MDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the safety and efficacy of ARD103, an autologous CAR-T therapy targeting CLL-1, in patients suffering from relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The study is designed as a phase I/II, open-label, multicenter trial, which means it will assess both the initial safety and the effectiveness of the treatment across multiple sites. Participants will receive ARD103 along with preparatory chemotherapy agents, Cyclophosphamide and Fludarabine, to enhance the CAR-T cell response. The focus is on patients with a specific expression of CLL-1, which is prevalent in myeloid malignancies but absent in normal stem cells.

Why it matters

Who can join: the full rules

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

Where it's running

• Novant Health Cancer Institute
  Charlotte, North Carolina, United States Recruiting
• Novant Health Cancer Institute
  Winston-Salem, North Carolina, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: ARCE Therapeutics, Inc
• Email: contact@arcetherapeutics.com
• Phone: +886-2-26581868

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term safety follow-up of ARD103 CAR-T cells in relapsed/refractory AML and MDS

  This long-term follow-up study checks whether ARD103 CAR-T cell therapy remains safe for patients with relapsed or refractory AML or MDS after the initial treatment.

  Recruiting at 3 sites ARCE Therapeutics, Inc. · Charlotte, North Carolina and 2 other locations · NCT06906380

• Using CAR-T cell therapy targeting Tim-3 and CD123 for treating relapsed acute myeloid leukemia

  This study is testing a new CAR-T cell therapy that targets specific markers in people aged 18-70 with relapsed acute myeloid leukemia to see if it can safely improve their treatment outcomes.

  Recruiting Phase 1/2 Xuzhou Medical University · Xuzhou, Jiangsu · NCT06125652

• Using CAR T cells to treat acute myeloid leukemia

  This study is testing a new treatment using specially modified CAR T cells to see if it can safely help adults and kids with tough cases of acute myeloid leukemia.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT06017258

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Combining cytokine-induced memory-like natural killer cells with atezolizumab for relapsed or refractory AML

  This trial will test whether giving cytokine-induced memory-like natural killer cells together with atezolizumab is safe and might help adults with relapsed or refractory acute myeloid leukemia.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07011004

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.