Health Trials

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

ConditionsHodgkin DiseaseCD30-Positive Diffuse Large B-Cell LymphomaCD30+ Anaplastic Large Cell LymphomaCD30+ Pleomorphic Large T-Cell Cutaneous LymphomaCD30+ Immunoblastic Large T-Cell Cutaneous LymphomaLeukemiaLymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC)
  • GM-CSF

Treatment groups

42 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov