RecruitingPhase 1NCT05365659

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (NHL)


Sponsor

Iksuda Therapeutics Ltd.

Enrollment

140 participants

Start Date

Sep 5, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called IKS03 for people with advanced B-cell non-Hodgkin lymphoma (a type of blood cancer) that has come back or stopped responding to other treatments. Researchers are studying how the drug works and what dose is safe. **You may be eligible if...** - You are 18 or older - You have a diagnosis of B-cell non-Hodgkin lymphoma (not Burkitt lymphoma or Waldenström's) - Your lymphoma has relapsed or is no longer responding to treatment - You have received at least 2 prior lines of therapy - Your lymphoma tests positive for a marker called CD19 - You are in good enough health to participate (ECOG performance status 0 or 1) **You may NOT be eligible if...** - Your lymphoma involves the brain or spinal cord - You are pregnant or breastfeeding - You have had a solid organ transplant - You have active HIV, hepatitis B, or hepatitis C - You have had a major heart event or serious heart condition - You have severe lung, liver, or kidney problems - You have had CD19-targeted therapy within the last 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIKS03

IKS03 is a human monoclonal antibody (Ab) targeting CD19 linked to a pyrrolobenzodiazepine (PBD) pro-drug as the cytotoxic agent.


Locations(13)

University of Maryland Baltimore

Baltimore, Maryland, United States

Westmead Hospital

Westmead, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Linear Clinical Research

Perth, Western Australia, Australia

Jewish General Hospital

Montreal, Quebec, Canada

La Fondazione e l'Istituto di Candiolo

Candiolo, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale San Raffaele

Milan, Italy

Istituto Europeo Clinico Humanitas

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Institut Catala D'Oncologia

Badalona, Spain

Hospital Universitario Quironsalud Madrid

Madrid, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

View Full Details on ClinicalTrials.gov

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NCT05365659


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