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

ConditionsHodgkin Disease CD30-Positive Diffuse Large B-Cell Lymphoma CD30+ Anaplastic Large Cell Lymphoma CD30+ Pleomorphic Large T-Cell Cutaneous Lymphoma CD30+ Immunoblastic Large T-Cell Cutaneous Lymphoma Leukemia Lymphoma

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC)
Drug
anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells
GM-CSF
Drug
Hematopoietic agent that helps form white blood cells.

Treatment groups

42 Participants

are divided into 5 treatment groups

Group A: CD30biAb-AATC (Dose Level -1 -- 40 x 10^6 cells/kg/infusion + GM-CSF 250 μg/m^2)Experimental treatment 2 interventions

Group B: CD30biAb-AATC (Dose Level 1 -- 80 x 10^6 cells/kg/infusion + GM-CSF 250 μg/m^2)Experimental treatment 2 interventions

Group C: CD30biAb-AATC (Dose Level 2 -- 120 x 10^6 cells/kg/infusion + GM-CSF 250 μg/m^2)Experimental treatment 2 interventions

Group D: CD30biAb-AATC (Dose Level 3 -- 160 x 10^6 cells/kg/infusion + GM-CSF 250 μg/m^2)Experimental treatment 2 interventions

Group E: CD30biAb-AATC Recommended Phase 2 Dose (RP2D)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Maximum Tolerated Dose

To determine the MTD and recommended Phase II dose of CD30 biAb-AATC administered once weekly for a total of 4 doses per cycle

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov

Apply now