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NCT05365659 · ClinicalTrials.gov registry record · Phase 1
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
A Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by Iksuda Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
- 13
- Study locations
NCT05365659: Recruiting Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, sponsored by Iksuda Therapeutics.
NCT05365659 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma that is actively recruiting participants, run by Iksuda Therapeutics. The registered enrollment target is 140 participants, below the 217-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (35% lower). The trial reports 13 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05365659, a Phase 1 study of Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma, is actively recruiting participants, sponsored by Iksuda Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
- 13
- Study locations
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).
Primary Outcome
RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Conditions Studied
Interventions
- DRUG IKS03
Study Locations (13)
Other
- La Fondazione e l'Istituto di Candiolo - Candiolo
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale San Raffaele - Milan
- Istituto Europeo Clinico Humanitas - Milan
- Istituto Europeo di Oncologia - Milan
- Institut Catala D'Oncologia - Badalona
- Hospital Universitario Quironsalud Madrid - Madrid
- Hospital Clinico Universitario de Salamanca - Salamanca
Maryland
- University of Maryland Baltimore - Baltimore
New South Wales
- Westmead Hospital - Westmead
South Australia
- Royal Adelaide Hospital - Adelaide
Tasmania
- Royal Hobart Hospital - Hobart
Western Australia
- Linear Clinical Research - Perth
Quebec
- Jewish General Hospital - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2023-09-05 |
| Est. Completion | 2028-09 |
| Phase | Phase 1 |
What NCT05365659 shows while recruiting
NCT05365659 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 217-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (35% lower).
The record links to 5 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which IKS03 is the first listed.
NCT05365659 lists 13 locations in 7 states (Other, Maryland, New South Wales).
Frequently Asked Questions
What is clinical trial NCT05365659 about?
NCT05365659 is a clinical study titled "IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas". 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 lymphom...
What is the current status of trial NCT05365659?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2023-09-05. Estimated completion is 2028-09.
What conditions does trial NCT05365659 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, B-cell Lymphoma, B-Cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT05365659?
The interventions under investigation include: IKS03 (DRUG).
Who is sponsoring clinical trial NCT05365659?
This trial is sponsored by Iksuda Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05365659 being conducted?
This trial has 13 study locations across Maryland, New South Wales, South Australia, Tasmania, Western Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05365659's enrollment target sits among peer trials
140 37th of 114 higher than 78 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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