2 completed, 2 recruiting, 1 active not recruiting, 1 available. 6 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 2, Recruiting 2, Active not recruiting 1, Not yet recruiting 1 |
| Phase 2 | 2 | Not yet recruiting 1, Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 1/2 Study to Evaluate the Safety and Efficacy of Dibotatug (DR-01) in Adults With Bone Marrow Failure Syndromes Dibotatug (DR-01) - Bone Marrow Failure Syndromes, Aplastic Anemias | Phase 1 / Phase 2 | Not yet recruiting | Dren Bio | 60 | 2026-08-01 | 2026-07-24 |
| A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas DR-0202 - Triple Negative Breast Cancer, HER2-negative Breast Cancer | Phase 1 | Recruiting | Dren Bio | 96 | 2025-06-03 | 2026-01-07 |
| A Study of Subcutaneous DR-01 in Healthy Volunteers DR-01, Placebo - Healthy Volunteer | Phase 1 | Completed | Dren Bio | 32 | 2025-03-03 | 2025-09-29 |
| A Study of DR-01 in Subjects With Alopecia Areata and Vitiligo DR-01 - Alopecia Areata, Vitiligo | Phase 1 | Active not recruiting | Dren Bio | 81 | 2024-10-30 | 2026-07-08 |
| A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers DR-0201, Placebo - Healthy Adult Volunteers | Phase 1 | Completed | Dren Bio | 10 | 2023-11-26 | 2024-08-13 |
| A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas DR-01 - LGLL - Large Granular Lymphocytic Leukemia, Primary Cutaneous Gamma-Delta T-Cell Lymphoma | Phase 1 / Phase 2 | Recruiting | Dren Bio | 200 | 2022-07-13 | 2026-06-17 |
| Availability of Dibotatug (DR-01) Outside Clinical Trials Via Expanded Access for Eligible Participants Dibotatug | Available | Dren Bio | 2026-06-15 |
Alopecia (1) · Alopecia Areata (1) · Anemia, Aplastic (1) · Bone Marrow Failure Disorders (1) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Transitional Cell (1) · Endometrial Neoplasms (1) · Enteropathy-Associated T-Cell Lymphoma (1) · Hair Diseases (1) · Hematologic Diseases (1) · Leukemia (1) · Leukemia, Large Granular Lymphocytic (1) · Leukocyte Disorders (1) · Lymphoma (1) · Lymphoma, Extranodal NK-T-Cell (1)
United States (4) · Australia (3) · New Zealand (2) · France (1) · Germany (1) · Hong Kong (1) · Italy (1) · South Korea (1) · Spain (1) · Taiwan (1)
Michael Rothenberg, MD, PhD (2) · Wan-Jen Hong, MD (2) · Matthias Will, MD (1) · Wan Jen Hong, MD (1)