A Phase I Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of Anti-CD30 Bispecific Antibody-Armed Anti-CD3-Activated Autologous T-Cells (CD30 biAb-AATC) in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies
Medical College of Wisconsin
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).
Description
Non-randomized, single arm, dose escalating, Phase I study evaluating the feasibility and safety of a novel anti-CD30 biAb-AATC product for adult patients with relapsed/refractory CD30+ cancer. Following T-cell collection patients are recommended to receive a bridging chemotherapy for 21 days while product is being generated and quality control assessed. Patients will then undergo weekly administration of dose escalating CD30 biAb-AATC infusions with twice weekly subcutaneous GM-CSF in 4-week cycles for a maximum of two total cycles.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Diagnosis: Patients must have had histologic or cytologic verification of the below qualified malignancy. The pathology report for the diagnosis under which the patient is being enrolled and associated molecular diagnostic reports must be submitted. a. Hodgkin's Lymphoma (HD): Patients with HD are eligible with one of the following: i. Second or greater recurrence or refractory to at least 2 prior therapeutic regimens. ii. Any relapse after HSCT. b. Non-Hodgkin Lymphoma (NHL): Patients with NHL are eligible with one of the following: i. Second or greater recurrence or…
Interventions
- Druganti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC)
anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells
- DrugGM-CSF
Hematopoietic agent that helps form white blood cells.
Location
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin