RecruitingPhase 1

Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies

United States42 participantsStarted 2026-03-04

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Direct Bilirubin \<1.5 x upper limit of normal (ULN) for age. For patients with documented Gilbert's syndrome (unconjugated hyperbilirubinemia) the bilirubin must be ≤3 x ULN for age.
✓. SGPT (ALT) \<3 x ULN.
✓. Serum albumin \>2 g/dL.
✓. Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 7 days prior to enrollment.
✓. Female patients must meet one of the following:

What they're measuring

Maximum Tolerated Dose

Timeframe: 2 years

Trial details

NCT IDNCT05544968

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Medical College of Wisconsin Cancer Center Clinical Trials Office

866-680-0505 cccto@mcw.edu

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