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NCT05544968 · ClinicalTrials.gov registry record · Phase 1
Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT05544968: Recruiting Phase 1 study, sponsored by Medical College of Wisconsin.
NCT05544968 is a Phase 1 study that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05544968, a Phase 1 study, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This first-in-human trial will assess the safety, feasibility, and efficacy of an immunotherapy with a novel CD30 antibody conjugated to a CD3 antibody that is preloaded onto a patient's own T-cells, generating a CD30 bispecific antibody-armed, anti-CD3-activated, autologous T-cells (CD30 biAb-AATC).
Primary Outcome
To determine the MTD and recommended Phase II dose of CD30 biAb-AATC administered once weekly for a total of 4 doses per cycle
Interventions
- DRUG GM-CSF
- DRUG anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2026-03-04 |
| Est. Completion | 2029-07 |
| Phase | Phase 1 |
What NCT05544968 shows while recruiting
NCT05544968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which GM-CSF is the first listed.
NCT05544968 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05544968 about?
NCT05544968 is a clinical study titled "Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies". This first-in-human trial will assess the safety, feasibility, and efficacy of an immunotherapy with a novel CD30 antibody conjugated to a CD3 antibody that is preloaded onto a patient's own T-cells, generating a CD30 bispecific antibody-armed, anti-CD3-activated, autologous T-cells (CD30 biAb-AATC)...
What is the current status of trial NCT05544968?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2026-03-04. Estimated completion is 2029-07.
What interventions are being tested in trial NCT05544968?
The interventions under investigation include: GM-CSF (DRUG), anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC) (DRUG).
Who is sponsoring clinical trial NCT05544968?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05544968's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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