Trials / Recruiting
RecruitingNCT05544968
Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- Medical College of Wisconsin · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed 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.
Conditions
- Hodgkin 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC) | anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells |
| DRUG | GM-CSF | Hematopoietic agent that helps form white blood cells. |
Timeline
- Start date
- 2026-03-04
- Primary completion
- 2028-01-01
- Completion
- 2029-07-01
- First posted
- 2022-09-19
- Last updated
- 2026-04-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05544968. Inclusion in this directory is not an endorsement.