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

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
ARCE Therapeutics, Inc.
Study ID
NCT06680752
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARD103 — BIOLOGICAL
    ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion
  • Cyclophosphamide — DRUG
    iv administration for lymphodepletion
  • Fludarabine — DRUG
    iv administration for lymphodepletion

Study Details

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.

Key Dates

Start date
May 20, 2025
Status verified
Dec 2025
Primary completion
Oct 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: phase 1 (Dose Escalation) and phase 2 (Dose Expansion)
    In Phase 1, three escalating dose levels will be tested using the 3 + 3 design. The MTD and RP2D will be identified. The Phase 2 will be conducted in 2 stages. In Stage I, evaluable participants from Phase 1 treated at RP2D will be enrolled. And the enrollment will continue into Stage II (additional evaluable participants) at the maximum RP2D participants for preliminary overall assessment of efficacy and safety.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 28 days post ARD103 infusion ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Novant Health Cancer InstituteCharlotteNorth Carolina28204
Kunal Shah
[email protected]
980-302-6297
Novant Health Cancer InstituteWinston-SalemNorth Carolina27201
Gait Jordan
[email protected]
336-718-8553
MD Anderson Cancer CenterHoustonTexas77030
Dr. Abhishek Maiti
[email protected]
713.745.3228

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By research site
Novant Health Cancer Institute· Charlotte, NCNovant Health Cancer Institute· Winston-Salem, NCMD Anderson Cancer Center· Houston, TX

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