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IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

NCT05365659 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-10-01

No results posted yet for this study

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).

Conditions

Interventions

DRUG

IKS03

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

Sponsors & Collaborators

  • Iksuda Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • Paul I Nadler, MD · Iksuda Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2026-09-30
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05365659 on ClinicalTrials.gov