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

Part of paid clinical trials in Duarte, California.

Sponsor
Dren Bio
Study ID
NCT07712562
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dibotatug (DR-01) — DRUG
    Dibotatug (DR-01) administered by IV infusion

Study Details

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.

Key Dates

First listed
Jul 17, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2029
Completion
Oct 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dibotatug (DR-01)
    Subjects in this arm will receive 20 weeks of dosing with dibotatug. Subjects with a CR or PR by Week 24 have the option to continue dosing through Week 48; Dibotatug will be administered via IV infusion.

Primary Outcome Measure

Efficacy of dibotatug in participants with BMF syndromes [ Time Frame: By 6 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Dren Investigational SiteDuarteCalifornia91010
Dren Bio Central Contact
[email protected]
415-737-5277
Dren Investigational SitePalo AltoCalifornia94304
Dren Bio Central Contact
[email protected]
415-737-5277
Dren Investigational SiteAtlantaGeorgia30342
Dren Bio Central Contact
[email protected]
415-737-5277
Dren Investigational SiteNew YorkNew York10065
Dren Bio Central Contact
[email protected]
415-737-5277
Dren Investigational SiteClevelandOhio44195
Dren Bio Central Contact
[email protected]
415-737-5277
Dren Investigational SiteColumbusOhio43210
Dren Bio Central Contact
[email protected]
415-737-5277
Dren Investigational SiteHoustonTexas77030
Dren Bio Central Contact
[email protected]
415-737-5277
Dren Investigational SiteFairfaxVirginia22031
Dren Bio Central Contact
[email protected]
415-737-5277
Dren Investigational SiteSeattleWashington98109
Dren Bio Central Contact
[email protected]
415-737-5277

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Dren Investigational Site· Duarte, CADren Investigational Site· Palo Alto, CADren Investigational Site· Atlanta, GADren Investigational Site· New York, NYDren Investigational Site· Cleveland, OHDren Investigational Site· Columbus, OH

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