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

NCT07712562 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-24

No results posted yet for this study

Summary

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.

Conditions

  • Bone Marrow Failure Syndromes
  • Aplastic Anemias
  • Severe Aplastic Anemia (SAA)
  • Severe Aplastic Anemia, Relapse
  • Severe Aplastic Anemia, Refractory
  • Non-severe Aplastic Anemia

Interventions

DRUG

Dibotatug (DR-01)

Dibotatug (DR-01) administered by IV infusion

Sponsors & Collaborators

  • Dren Bio

    lead INDUSTRY

Principal Investigators

  • Wan-Jen Hong, MD · Dren Bio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-04-30
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712562 on ClinicalTrials.gov