Actively Recruiting
Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies
Led by Medical College of Wisconsin · Updated on 2026-04-03
42
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with histologic or cytologic confirmation of qualified CD30-positive hematopoietic malignancy.
- Diagnosis of Hodgkin's lymphoma with second or greater recurrence or refractory to at least 2 prior therapies, or any relapse after hematopoietic stem cell transplant (HSCT).
- Diagnosis of non-Hodgkin lymphoma with second or greater recurrence or refractory to at least 2 prior therapies, or relapse after HSCT or CAR T-cell therapy.
- Diagnosis of acute myeloid leukemia with first or greater relapse, or primary refractory disease after at least 1 induction attempt.
- Diagnosis of acute lymphoblastic leukemia with second or greater relapse or refractory to at least 2 prior therapies, or relapse after HSCT or CAR T-cell therapy.
- Other hematopoietic malignancies without effective standard curative treatments.
- Confirmed CD30 cell surface expression on malignant cells by appropriate testing at most recent disease assessment.
- Measurable disease for lymphomas or relapsed/refractory disease for leukemias.
- Recovery from prior chemotherapy toxicities to Grade 2 or lower.
- No myelosuppressive chemotherapy within 3 weeks before lymphocyte collection.
- Required intervals after growth factors, biologics, immunotherapy, monoclonal antibodies, and radiation therapy before study entry.
- Life expectancy greater than 12 weeks.
- Karnofsky performance status 50% or higher.
- Adequate organ function including kidney, liver, lung, and heart.
- For lymphoma patients without bone marrow involvement: adequate blood counts; for those with involvement: eligibility with transfusion support.
- Female patients of childbearing potential must have a negative pregnancy test and use effective contraception or practice true abstinence during and for three months after study treatment.
- Male patients must agree to use effective barrier contraception or abstinence during and for three months after study treatment.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Grade 3 or higher toxicities from prior treatments.
- Hematopoietic stem cell transplant or CAR T-cell therapy within 60 days before enrollment or evidence of veno-occlusive disease post-transplant.
- Treatment with any investigational agent within 14 days before enrollment.
- Immunodeficiency diagnosis or use of chronic systemic steroids or immunosuppressive therapy within 7 days before first study dose.
- Uncontrolled systemic infections despite treatment.
- HIV-positive patients on combination antiretroviral therapy.
- History of pulmonary toxicity related to anti-CD30 therapy.
- History of progressive multifocal leukoencephalopathy (PML).
- NYHA Class III or IV heart failure, ventricular arrhythmias, or uncontrolled hypertension.
- Known allergy to components of CD30 biAb-AATC or similar agents.
- Pregnant or breastfeeding women.
- History of second malignancy within the last year except certain skin cancers or those disease-free for at least one year.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
M
Medical College of Wisconsin Cancer Center Clinical Trials Office, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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