Treatment with ARD103 CAR-T therapy for patients with relapsed or refractory 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
PHASE1; PHASE2 · ARCE Therapeutics, Inc. · NCT06680752
This study is testing a new CAR-T therapy called ARD103 to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia or myelodysplastic syndrome.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ARCE Therapeutics, Inc. (industry) |
| Drugs / interventions | chemotherapy, prednisone, CAR-T, chimeric antigen receptor |
| Locations | 3 sites (Charlotte, North Carolina and 2 other locations) |
| Trial ID | NCT06680752 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with documented relapsed or refractory AML or MDS with a certain level of bone marrow blasts.
Not a fit: Patients with acute promyelocytic leukemia or significant central nervous system disorders may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat forms of AML and MDS.
How similar studies have performed: Other studies using CAR-T therapies targeting similar markers have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlotte, North Carolina and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, MDS