anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC) for Lymphoma, Undifferentiated

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Wisconsin, Milwaukee, WI
Lymphoma, Undifferentiated+14 More
anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC) - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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).

Eligible Conditions

  • Lymphoma, Undifferentiated
  • Germ Cell Tumor, Extragonadal
  • Tumors, Solid
  • Pediatrics Cancer
  • Lymphoma, T-Cell, Cutaneous
  • Neuroblastoma
  • Hodgkin Disease
  • Chondrosarcoma
  • Lymphoma
  • CD30-Positive Diffuse Large B-Cell Lymphoma
  • CD30+ Anaplastic Large Cell Lymphoma
  • Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 3 years

3 years
Collection and Expansion Feasibility - Success Rate Whole blood
Define Toxicities - CTCAE v5.0
Define anti-tumor activity - Objective Response Rate
Define anti-tumor activity - Time-to-event efficacy
In vitro activity - quantitative cytotoxicity
Maximum Tolerated Dose
Patient Reported Outcomes - PROMIS 29 Profile Version 2.1
Pediatric Patient Reported Outcomes - PROMIS Pediatric 25 Profile Version 2.0
Pharmacokinetics of CD30 biAb-AATC - AUC(0-28day)
Pharmacokinetics of CD30 biAb-AATC - Cmax

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

CD30biAb-AATC
1 of 1
Experimental Treatment

42 Total Participants · 1 Treatment Group

Primary Treatment: anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC) · No Placebo Group · Phase 1 & 2

CD30biAb-AATC
Drug
Experimental Group · 1 Intervention: anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
Closest Location: Children's Wisconsin · Milwaukee, WI
Photo of Milwaukee 1Photo of Milwaukee 2Photo of Milwaukee 3
2019First Recorded Clinical Trial
0 TrialsResearching Lymphoma, Undifferentiated
2 CompletedClinical Trials

Who is running the clinical trial?

Midwest Athletes Against Childhood CancerUNKNOWN
Medical College of WisconsinLead Sponsor
545 Previous Clinical Trials
1,150,343 Total Patients Enrolled
Nathan Schloemer, MDPrincipal InvestigatorMedical College of Wisconsin / Children's Wisconsin

Eligibility Criteria

Age < 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients must have ≥ 5% (M2 or M3) bone marrow blasts with or without extramedullary disease.
Patients must have measurable or evaluable disease based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria from the NCI for assessment of radiographic response.
Patients must have measurable disease for assessment of radiographic response.
Patients must have fully recovered from the acute toxic effects of all prior anticancer chemotherapy, defined as resolution of all such toxicities to ≤ Grade 2 or lower per the inclusion/exclusion criteria.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.