Health Trials

A Phase 1/2 Study to Evaluate the Safety and Efficacy of Dibotatug (DR-01) in Adults With Bone Marrow Failure Syndromes

ConditionsBone Marrow Failure SyndromesAplastic AnemiasSevere Aplastic Anemia (SAA)Severe Aplastic Anemia, RelapseSevere Aplastic Anemia, RefractoryNon-severe Aplastic Anemia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDren Bio

About this trial

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.

Eligibility criteria

Qualifiers

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.

Participants with SAA must have a current or prior diagnosis of SAA or very SAA.

Received one ≥ 3-month course of ATG and/or CSA-based IST.

Disqualifiers

Diagnosis of Fanconi anemia, dyskeratosis congenita, or other congenital BMF syndrome.

Prior HCT.

Planning to receive HCT as treatment for AA.

Evidence of a clonal disorder with poor risk cytogenetics per Revised International Prognostic Scoring System (IPSS-R) for MDS.

Trial design

Treatments tested in this trial

  • Dibotatug (DR-01)

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Dren Bio

Lead sponsor

Source ClinicalTrials.gov