IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
Trial Parameters
Brief Summary
This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).
Eligibility Criteria
Inclusion Criteria: 1. Males or females, ≥ 18 years of age 2. Part 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible 3. Part 2: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include: 1. Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type) 2. Follicular lymphoma (including duodenal-type follicular lymphoma) 3. Mantle cell lymphoma 4. B cell lymphomas not specified 4. If B cell NHL subtype likely to have bone marrow involvement must be willing to undergo bone marrow biopsy in the event of an on-study complete response to confirm response 5. NHL that is relapsed, refractory to, or intolerant of existing therapy(ies) with known curative potential, or for which no standard therapy is available; must have received at least 2 prior lines of systemic therapy 6. Must be in ne