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

Recruiting now · Phase 1

Conditions studied: 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

In brief

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).

Key facts

Study ID: NCT05544968
Run by: Medical College of Wisconsin
People needed: 42
Starts: 2026-03-04
Expected to finish: 2029-07-01
Last updated by the study team: 2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 refractory to at least 2 prior therapeutic regimens.
ii. Any relapse after HSCT or CAR T cell therapy.
c. Acute Myeloid Leukemia (AML): Patients with AML are eligible with one of the following:
i. First or greater relapse.
ii. Primary refractory disease with at least 1 prior induction attempts.
d. Acute Lymphoblastic Leukemia (ALL): Patients with ALL are eligible with one of the following:
i. Second or greater relapse or refractory to at least 2 prior therapeutic regimens.
ii. Any relapse after HSCT or CAR T cell therapy.
e. Other Hematopoietic malignancy not listed above for which standard curative measures do not exist, are not proven to prolong survival with an acceptable quality of life, or are no longer effective.
CD30 Expression Status: Disease specific histologic, cytologic, or Fluorescence-Activated Cell Sorting (FACS)-confirmed CD30 cell surface expression on malignant cells is required. CD30 surface expression must be confirmed at most recent histologic, cytologic, or FACS assessment of disease. This confirmation must occur at recurrence. No repeat CD30 expression verification is required for patients with primary refractory diseases. Pathology and diagnostic reports verifying the CD30 expression status must be submitted.
Leukemia CD30 Expression Criteria: Flow cytometry immunophenotypic analysis of bone marrow or peripheral blood. Surface expression of CD30 expression on blasts "positive" with ≥20% expression consistent with established precedents.
Lymphoma CD30 Expression Criteria: Flow cytometry immunophenotypic analysis of lymphoma sample or immunohistochemical assessment of formalin-fixed paraffin embedded sample. Flow cytometry assessment surface expression or immunohistochemical membranous expression of CD30 on neoplastic cells "positive" with ≥ 1% expression consistent with established precedents.
Disease Status:
i. Lymphomas: Patients must have measurable disease for assessment of radiographic response defined as either nodal disease >/=1.5 cm or extranodal lesion >/=1.0 cm.
ii. Leukemias: Patients must have relapsed/refractory (including MRD >0.01% by flow cytometry) disease.
Prior Therapy: Patients must have recovered from the acute toxic effects of prior anticancer chemotherapy, defined as resolution of all such toxicities to ≤ Grade 2 or lower prior to entering this study and initiating lymphocyte collection.
i. Myelosuppressive chemotherapy: Patients must not have received myelosuppressive therapy within 3 weeks of apheresis for this study.
ii. Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
iii. Biologic (anti-neoplastic agent): At least 7 days after the last of a biologic agent that is not a monoclonal antibody and infusion of study product on this study. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
iv. Immunotherapy: At least 6 weeks since the completion of any type of immunotherapy, e.g., tumor vaccines or CAR T-cell therapy.

You may not qualify if…

Prior Therapy: Any toxicities from prior treatment, >Grade 3 per CTCAE v5.0 Hematopoietic stem cell transplantation (HCT) or chimeric antigen receptor T-cell therapy (CAR-T cell) within 60 days of enrollment, or evidence of veno-occlusive disease (VOD) at any time post-transplant.
Investigational Agent: Treatment with any investigational agent within 14 days of enrollment.
Exclusion Requirements Due to Comorbid Disease or Concurrent Illness:
Immune: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Steroid premedication for imaging scans is allowed. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Infectious: Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment). Patients with possible fungal infections must have had appropriate anti-fungal antibiotics and adequately controlled. HIV-positive patients on combination antiretroviral therapy are ineligible because of the unknown ability to expand T cell populations for CD30 biAb-AATC product in this setting. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Pulmonary: Prior history of anti-CD30 therapy related pulmonary toxicity.
Neurologic: Prior history of progressive multifocal leukoencephalopathy (PML).
Cardiac: Patients diagnosed with NYHA Class III or IV congestive heart failure, ventricular arrhythmias, or uncontrolled hypertension.
Allergies: Known hypersensitivity or allergic reaction attributed to any of the components of CD30 biAb-AATC or to compounds of similar composition to CD30 targeted agent, or a bispecific Antibody-armed activated autologous T cell product.
Pregnant or Breastfeeding: Pregnant or breastfeeding females will not be allowed to enroll on this study. Female patients with infants must agree not to breastfeed their infants during the entire study treatment period and through three months after the last study drug dose. Agents used in this study are known to be teratogenic to a fetus. There is there is no information on the excretion of CD30 biAb-AATC agents into breast milk but potential risk for adverse events in nursing infants secondary to treatment of the mother with a CD30 biAb-AATC.
Secondary Malignancy: Patients should not have a history of any second malignancy in the last 1 year with exception of the diagnosis for inclusion; subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Subjects with other malignancies are eligible if they have been continuously disease free for at least 1 year.

Where it is running

Froedtert & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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