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B-cell Non-Hodgkin LymphomaPhase 1NCT05365659

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

A Phase 1 study testing IKS03 in people with B-cell Non-Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by Iksuda Therapeutics Ltd. at 13 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IKS03
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
13 sitesin 5 countries
Study dates
5 Sep 2023to Sep 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females, ≥ 18 years of age
  • Part I: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible
  • Part II: 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
Show all 16Show fewer
  • 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 I: measurable or non-measurable disease
  • Part II: measurable disease according to The Revised Criteria/Lugano Classification
  • Part I: screening tumor biopsy requested, but optional; Part 2: patient must agree to screening tumor biopsy
  • ECOG performance status 0 or 1
  • 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.
  • Ability to understand and give written informed consent

Who cannot join

  • 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)
Show all 78Show fewer
  • 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
  • AST or ALT > 3 × ULN; > 5 × ULN if due to hepatic involvement by tumor
  • Estimated GFR ≤ 60 mL/min corrected for BSA
  • Albuminuria defined as urine albumin to creatinine ratio < 30 mg/g or < 3 mg/mmol) by spot urine albumin
  • Any of the following coagulation parameter abnormalities at baseline unless on a stable dose of anticoagulant therapy for a prior thrombotic event:
  • PT or INR > 1.5 × ULN; > 3× ULN if anticoagulated)
  • PTT > 1.5 × ULN; > 3× ULN if anticoagulated
  • Any of the following laboratory abnormalities at baseline aimed at assessing renal function:
  • Estimated glomerular filtration rate (eGFR) ≤ 60 mL/min, corrected for BSA.
  • Albuminuria defined as urine albumin to creatinine ratio (UACR) ≥ 45 mg/g or ≥ 4.5 mg/mmol by spot urine albumin
  • Patients with:
  • Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks unless adequately treated and stable
  • Active uncontrolled bleeding or a known bleeding diathesis
  • Significant cardiovascular disease or condition, including:
  • Congestive heart failure or angina pectoris requiring therapy
  • Ventricular arrhythmia requiring therapy or other uncontrolled arrhythmia
  • Severe conduction disturbance (e.g., 3rd degree heart block)
  • QTc interval ≥ 480 milliseconds
  • Left ventricular ejection fraction below the lower limit of normal or < 50% by MUGA scan or echocardiogram
  • Class III or IV cardiovascular disease according to the New York Heart Association Functional Classification
  • History of acute coronary syndromes (e.g., MI, unstable angina), coronary angioplasty, stenting, or bypass within 6 months
  • Significant liver disease, including:
  • Non-infectious hepatitis
  • Hepatic cirrhosis (Child-Pugh Class B and Class C)
  • Significant pulmonary disease or condition, including:
  • Significant symptomatic COPD, as assessed by the Investigator
  • History or any current evidence on imaging studies of interstitial lung disease, pulmonary fibrosis
  • History of pulmonary inflammatory disease, pneumonitis, ARDS
  • History of pneumonia within 1 month
  • Significant corneal disease or condition, including history of or current evidence of keratitis
  • Clinically significant CNS disease or condition including PML, epilepsy, vasculitis, or neurodegenerative disease. Also including TIA or stroke within 6 months
  • Known HIV infection or AIDS
  • Active hepatitis B virus or hepatitis C virus infection
  • Any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks
  • Autoimmune disease or condition requiring systemic steroids or other immunosuppressive medications
  • Unresolved Grade > 1 AE associated with any prior antineoplastic therapy (except persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, neutropenia, lymphopenia, hypomagnesemia, and/or endocrine end-organ failure being adequately managed by HRT)
  • Known or suspected hypersensitivity to any of the excipients of formulated study drug
  • Inadequate recovery from a surgical procedure, or a major surgical procedure within 4 weeks
  • Any other serious, life-threatening, or unstable preexisting medical condition, including significant organ system dysfunction, or clinically significant laboratory abnormality(ies)
  • A psychiatric disorder or altered mental status that would preclude understanding of the informed consent process
  • Drugs and Other Treatments to be Excluded:
  • Receipt of:
  • Any CD19-targeted therapy within 4 weeks
  • Any tumor vaccine within 6 weeks (must have progressed if previously received)
  • Prior autologous/allogeneic CAR-T therapy if known to be CD19-negative after
  • Any other antineoplastic agent for the primary malignancy without delayed toxicity within 3 weeks or 5 plasma half-lives, whichever is shortest (except nitrosoureas and mitomycin C within 6 weeks)
  • Any other investigational treatments within 3 weeks
  • Drugs known to impair renal function, including:
  • NSAIDS within 3 days
  • Aminoglycoside antibiotics, amphotericin B, etc. within 1 week
  • Bisphosphonates within 1 month
  • Prior solid organ transplant
  • Allogeneic HSCT within 6 months, or:
  • If receiving immunosuppression
  • If with active evidence of GVHD
  • Autologous hematopoietic stem cell transplantation (HSCT) within 3 months
  • Radiotherapy:
  • To target lesions within 4 weeks unless progression of the lesion has been documented
  • To non-target lesions within 1 week
  • Live/live-attenuated vaccines against infectious diseases within 4 weeks
  • Immunosuppressive or systemic glucocorticoid therapy (> 10 mg prednisone daily or equivalent) within 2 weeks
  • Prophylactic use of hematopoietic growth factors within 1 week
  • Herbal therapies and supplements within 2 weeks
  • Strong inhibitors of cytochrome P450 within 2 weeks

Trial locations and contacts

13 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

David Browning contact

615-975-7776

david.browning@iksuda.com

13 sites in 5 countries

Australia4 sites, 4 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia

    Pratyush Giri, MBBS

    Pratyush Giri, MBBS

    Recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

    Rosemary Harrup, MD

    Recruiting

  • Linear Clinical Research

    Perth, Western Australia

    Katharine Lewis, MD

    Katharine Lewis, MD

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Amanda Johnston, MD

    Recruiting

Other trials in Australia

Italy4 sites, 4 recruiting

  • Istituto Nazionale Oncologico Candiolo

    Candiolo

    Umberto Vitolo, M.D.

    Umberto Vitolo, M.D.

    Recruiting

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

    Milan

    Andres Jose Maria Ferreri, M.D.

    Andres Jose Maria Ferreri, M.D.

    Recruiting

  • Istituto Europeo Clinico Humanitas

    Milan

    Carmelo Carlo-Stella, M.D.

    Carmelo Carlo-Stella, M.D.

    Recruiting

  • Istituto Europeo di Oncologia

    Milan

    Enrico Derenzini, M.D.

    Enrico Derenzini, M.D.

    Recruiting

Other trials in Italy

Spain3 sites, 3 recruiting

  • Institut Catala D&#39;Oncologia

    Badalona

    Mireia Franch-Sarto, M.D.

    Mireia Franch-Sarto, M.D.

    Recruiting

  • Hospital Universitario Quironsalud Madrid

    Madrid

    Maria del Carmen Martinez-Chamorro, M.D.

    Maria del Carmen Martinez-Chamorro, M.D.

    Recruiting

  • Hospital Clinico Universitario de Salamanca

    Salamanca

    Alejandro Martin Garcia-Sancho, M.D.

    Alejandro Martin Garcia-Sancho, M.D.

    Recruiting

Other trials in Spain

United States1 site

  • University of Maryland Baltimore

    Baltimore, Maryland, 21201

    Withdrawn

Other trials in United States

Canada1 site, 1 recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Sarit Assouline, MD

    Sarit Assouline, MD

    Recruiting

Other trials in Canada

About this study

Official title: 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)

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).

Read the detailed description

The study will consist of 2 parts: dose-escalation (Part I) and dose-expansion (Part II). The dose-escalation part (Part I) of the study is to evaluate the safety and tolerability of increasing dose levels of IKS03 to establish a recommended Phase 2 dose (RP2D); and the dose-expansion part (Part II) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of IKS03 at the RP2D.

Being tested
IKS03
Keywords
CD19, non-Hodgkin lymphoma, NHL, DLBCL, MCL, advance lymphoma, IKS03, lymphoma
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IKS03Drug

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

Study groups in NCT05365659
Study groupRoleWhat they receive
Dose Escalation Cohort (Part 1)ExperimentalEach 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 criterion is met.
Receives: Drug: IKS03
Dose Expansion: Diffuse-Large B-Cell Lymphoma ParticipantsExperimentalEach patient will receive IKS03 at the RP2D defined in Part I on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Receives: Drug: IKS03
Dose Expansion: Follicular Cell Lymphoma ParticipantsExperimentalEach patient will receive IKS03 at the RP2D defined in Part I on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Receives: Drug: IKS03
Dose Expansion: Mantle Cell Lymphoma ParticipantsExperimentalEach patient will receive IKS03 at the RP2D defined in Part I on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Receives: Drug: IKS03
Dose Expansion: Other B cell lymphoma (B-NHL not otherwise specified [NOS])ExperimentalEach patient will receive IKS03 at the RP2D defined in Part I on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Receives: Drug: IKS03

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose (Part I)

    RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

    Measured: Up to 20 months

  2. Objective Response Rate (Part II)

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

    Measured: up to 42 months

Secondary outcomes (3)

  1. Evaluation of the immunogenicity of IKS03 (Part I and II)

    Occurrence of ADA measured in serum at selected timepoints during the study

    Measured: Up to 42 months

  2. Plasma Concentrations of IKS03 (Part I and II)

    Pharmacokinetic profile will be characterized by concentrations of IKS03

    Measured: Up to 42 months

  3. Determine recommended Phase 2 dose (RP2D) (Part II)

    Based on evidence of antitumor activity, acceptable tolerability, evidence of achieving target plasma concentration

    Measured: Up to 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start5 Sep 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05365659
Sponsor's protocol ID
IKS03-01
Status last verified
Nov 2026
First submitted
2 May 2022
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IKS03 in people with B-cell Non-Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by Iksuda Therapeutics Ltd. at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 78 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Australia, Italy, Spain, United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Browning (615-975-7776, david.browning@iksuda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (Part I) (time frame: Up to 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05365659.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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