Dren Bio
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.
Study DR-01-HEM-001 is an open-label Phase 1/2 study evaluating the safety and efficacy of dibotatug in adult patients with BMF syndromes. Participants will be enrolled across three cohorts. Cohort A includes relapsed Severe Aplastic Anemia participants, Cohort B includes refractory Severe Aplastic Anemia participants, and Cohort C includes relapsed or refractory transfusion dependent Nonsevere Aplastic Anemia participants. Stage 1 will evaluate the safety and preliminary efficacy in up to 12 evaluable participants, and if deemed appropriate by a Safety Review Committee, the study will continu…
Inclusion Criteria: * Age ≥ 18 years old * Women of childbearing potential and males must agree to use 2 methods of effective contraception, with at least 1 method being highly effective. Inclusion Criteria for Severe Aplastic Anemia (SAA) (Cohorts A and B): * Participants with SAA must have a current or prior diagnosis of SAA or very SAA. Inclusion Criteria for Refractory Severe Aplastic Anemia (Cohort A) Participants with refractory SAA must have: * Received one ≥ 3-month course of ATG and/or CSA-based IST. * Refractory SAA, defined as failure to achieve CR or PR ≥ 3 months after starti…
Dibotatug (DR-01) administered by IV infusion