NCT05365659

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).

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
28mo left

Started Sep 2023

Longer than P75 for phase_1

Geographic Reach
5 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Sep 2023Sep 2028

First Submitted

Initial submission to the registry

May 2, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

May 2, 2022

Last Update Submit

September 26, 2025

Conditions

B-cell Non-Hodgkin LymphomaDiffuse Large B Cell LymphomaFollicular LymphomaMantle Cell LymphomaB-cell Lymphoma

Keywords

CD19non-Hodgkin lymphomaNHLDLBCLMCLadvance lymphomaIKS03lymphoma

Outcome Measures

Primary Outcomes (2)

  • Recommended Dose for Expansion (Part 1)

    RDE will be determined using dose limiting toxicities (DLTs) and all other available study data

    Up to 20 months

  • Objective Response Rate (Part 2)

    Antineoplastic effects will be assessed by Criteria for Response Assessment: The Lugano Classification (Cheson 2014)

    up to 42 months

Secondary Outcomes (3)

  • Evaluation of the immunogenicity of IKS03 (Part 1 and 2)

    Up to 42 months

  • Plasma Concentrations of IKS03 (Part 1 and 2)

    Up to 42 months

  • Determine recommended Phase 2 dose (RP2D) (Part 2)

    Up to 42 months

Study Arms (5)

Dose Escalation Cohort (Part 1)

EXPERIMENTAL

Each patient will receive repeat doses (by intravenous (IV) infusions) on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Drug: IKS03

Dose Expansion: Diffuse-Large B-Cell Lymphoma Participants

EXPERIMENTAL

Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Drug: IKS03

Dose Expansion: Follicular Cell Lymphoma Participants

EXPERIMENTAL

Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Drug: IKS03

Dose Expansion: Mantle Cell Lymphoma Participants

EXPERIMENTAL

Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Drug: IKS03

Dose Expansion: Other B cell lymphoma (B-NHL not otherwise specified [NOS])

EXPERIMENTAL

Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Drug: IKS03

Interventions

IKS03DRUG

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

Dose Escalation Cohort (Part 1)Dose Expansion: Diffuse-Large B-Cell Lymphoma ParticipantsDose Expansion: Follicular Cell Lymphoma ParticipantsDose Expansion: Mantle Cell Lymphoma ParticipantsDose Expansion: Other B cell lymphoma (B-NHL not otherwise specified [NOS])

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females, ≥ 18 years of age
  • Part 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible
  • Part 2: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include:
  • Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type)
  • Follicular lymphoma (including duodenal-type follicular lymphoma)
  • Mantle cell lymphoma
  • B cell lymphomas not specified
  • 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
  • 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
  • Must be in need of systemic treatment and not require immediate cytoreductive therapy
  • Part 1: measurable or non-measurable disease
  • Part 2: measurable disease according to The Revised Criteria/Lugano Classification
  • Part 1: screening tumor biopsy requested, but optional; Part 2: patient must agree to screening tumor biopsy
  • ECOG performance status 0 or 1; anticipated life expectancy ≥ 10 weeks
  • Women of childbearing potential and fertile men agreeing to use two effective methods of contraception (including a highly effective method of contraception); women beginning 2 weeks prior to the first dose, men beginning prior to the first dose, and both continuing until 8 months after the last dose of study drug; male patients must also agree to refrain from sperm donation during this period.
  • +1 more criteria

You may not qualify if:

  • Women who are pregnant or intending to become pregnant before, during, or within 8 months after the last dose of study drug; women who are breastfeeding
  • Patients documented to be CD19-negative
  • Central nervous system (CNS) lymphoma, leptomeningeal infiltration, or spinal cord compression not controlled by prior surgery or radiotherapy; symptoms suggesting CNS involvement
  • Part 2: History of another malignancy within 2 years, with the exception of:
  • Treated, non-melanoma skin cancers
  • Treated carcinoma in situ (e.g., breast, cervix)
  • Controlled, superficial carcinoma of the urinary bladder
  • T1a or b prostate carcinoma treated according to standard of care, with PSA within normal limits
  • Papillary thyroid carcinoma Stage I treated surgically for cure
  • Any of the following hematologic abnormalities at baseline (transfusion allowed \> 5 days previous):
  • Hemoglobin \< 8.0 g/dL
  • Absolute neutrophil count \< 1,000 per mm3
  • Platelet count \< 75,000 per mm3
  • Any of the following laboratory abnormalities at baseline:
  • Total bilirubin \> 1.5 × upper limit of normal (ULN); \> 3 × ULN if with Gilbert's Syndrome
  • +63 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

WITHDRAWN

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

RECRUITING

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

RECRUITING

Linear Clinical Research

Perth, Western Australia, Australia

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

La Fondazione e l'Istituto di Candiolo

Candiolo, Italy

RECRUITING

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

Milan, Italy

RECRUITING

Istituto Europeo Clinico Humanitas

Milan, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, Italy

RECRUITING

Institut Catala D&#39;Oncologia

Badalona, Spain

RECRUITING

Hospital Universitario Quironsalud Madrid

Madrid, Spain

RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, Mantle-CellLymphoma, Non-HodgkinLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Paul I Nadler, MD

    Iksuda Therapeutics

    STUDY DIRECTOR

Central Study Contacts

David Browning

CONTACT

615-975-7776david.browning@iksuda.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 9, 2022

Study Start

September 5, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)ES(3)IT(4)CA(1)AU(4)