Actively Recruiting
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
Led by Iksuda Therapeutics Ltd. · Updated on 2025-10-01
140
Participants Needed
13
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Documented B cell non-Hodgkin lymphoma (NHL) for Part 1, excluding certain subtypes; confirmed CD19-positive if feasible
- For Part 2, documented CD19-positive B cell NHL of specified subtypes including diffuse large B cell lymphoma, follicular lymphoma, mantle cell lymphoma, or other B cell lymphomas
- Willingness to undergo bone marrow biopsy if bone marrow involvement is likely and complete response occurs
- NHL that is relapsed, refractory, or intolerant to existing therapies, with at least 2 prior systemic treatment lines
- Need for systemic treatment without requiring immediate cytoreductive therapy
- Measurable or non-measurable disease in Part 1; measurable disease per revised criteria in Part 2
- Agreement to screening tumor biopsy in Part 2 (optional in Part 1)
- ECOG performance status of 0 or 1 with expected life expectancy of at least 10 weeks
- Women of childbearing potential and fertile men must agree to use two effective contraception methods from 2 weeks before first dose until 8 months after last dose
- Ability to understand and provide written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women, or those intending pregnancy during or within 8 months after study drug administration
- Patients documented as CD19-negative
- Central nervous system lymphoma or related complications not controlled by prior treatment
- History of other malignancies within 2 years except certain treated and controlled cancers
- Severe hematologic abnormalities at baseline (low hemoglobin, neutrophils, or platelets)
- Significant liver, kidney, coagulation, cardiovascular, pulmonary, corneal, or central nervous system diseases or abnormalities
- Known HIV or active hepatitis B or C infection
- Active serious infections or infections requiring IV antibiotics recently
- Autoimmune diseases needing systemic steroids or immunosuppressants
- Unresolved significant adverse events from prior cancer therapies
- Known hypersensitivity to study drug components
- Inadequate surgical recovery or major surgery within 4 weeks
- Other serious unstable medical or psychiatric conditions precluding consent or participation
- Recent use of excluded drugs or treatments including CD19-targeted therapy within 3 months, tumor vaccines within 6 weeks, recent antineoplastic agents, investigational treatments, certain antibiotics, NSAIDs, bisphosphonates, transplants, radiotherapy, live vaccines, immunosuppressive therapies, hematopoietic growth factors, herbal supplements, or strong cytochrome P450 inhibitors within specified timeframes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
Withdrawn
2
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Actively Recruiting
4
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Actively Recruiting
5
Linear Clinical Research
Perth, Western Australia, Australia
Actively Recruiting
6
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
7
La Fondazione e l'Istituto di Candiolo
Candiolo, Italy
Actively Recruiting
8
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale San Raffaele
Milan, Italy
Actively Recruiting
9
Istituto Europeo Clinico Humanitas
Milan, Italy
Actively Recruiting
10
Istituto Europeo di Oncologia
Milan, Italy
Actively Recruiting
11
Institut Catala D'Oncologia
Badalona, Spain
Actively Recruiting
12
Hospital Universitario Quironsalud Madrid
Madrid, Spain
Actively Recruiting
13
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Actively Recruiting
Research Team
D
David Browning
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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