Phase 1/2Recruiting
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Dibotatug (DR-01) in Adults With Bone Marrow Failure Syndromes (BMF)
A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Dibotatug in Adults With Bone Marrow Failure Syndromes
- Sponsor
- Dren Bio (Industry)
- Enrollment
- 60 planned
- Conditions
- Bone Marrow Failure Syndromes; Aplastic Anemias; Severe Aplastic Anemia (SAA); Severe Aplastic Anemia, Relapse; Severe Aplastic Anemia, Refractory; Non-severe Aplastic Anemia
- Interventions
- Dibotatug (DR-01)
- Ages
- adults, older adults
- Registry
- NCT07712562
Full record on ClinicalTrials.gov
From the registry
This is a multicenter, open-label, Phase 1/2 basket study to evaluate the safety and efficacy of Dibotatug (DR-01) in adults with Bone Marrow Failure syndromes.
Primary outcomes
- Overall Response Rate of Dibotatug (defined as proportion of subjects with a Complete Response or Partial Response) [Efficacy]
- Incidence and severity of adverse events as assessed by CTCAE v6.0 [Safety and Tolerability]
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered