A Phase 1, Multicenter, Open-label, Prospective, First-in-human Dose-escalation Clinical Trial of Domain Therapeutics' Anti-CCR8 Monoclonal Antibody (DT-7012) in Patients With Relapsed or Refractory Cutaneous T-cell Lymphomas (CTCL)
Plain-language summary
This trial is testing DT-7012 for patients with cutaneous T-cell lymphoma (CTCL), including mycosis fungoides or Sézary syndrome whose disease has come back or stopped responding to prior treatment. This is an early Phase 1 trial, which means this is among the first tests of the treatment in patients, focusing on safety and dose. This trial does not currently have sites in the United States. The trial is not yet open for recruitment.
Who can join (key eligibility)
- Age 18 Years or older
- Lymphoma came back or did not respond to prior treatment
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
DT-7012 (DRUG): This study use the Bayesian one-stage time-to-event continual reassessment method (TITE-CRM) design for dose finding phase I clinical trials, using an empirical dose-toxicity model with linear weights. A maximum total of 30 patients with CTCL, given 4 candidate dose levels (0.3; 1.0; 3.0; 10.0 mg/kg) will be dose-assigned starting from 1mg/kg dose level, in cohorts of 1 patient and including safety rules notably to ensure staggered accrual.
DT-7012
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details