IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

Recruiting now · Phase 1

Conditions studied: B-cell Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, B-cell Lymphoma

In brief

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).

Key facts

Study ID

NCT05365659

Run by

Iksuda Therapeutics Ltd.

People needed

140

Starts

2023-09-05

Expected to finish

2028-09-01

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

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
• 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:

Where it is running

• Hospital Clinico Universitario de Salamanca — Salamanca, Spain (enrolling)
• Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
• Royal Hobart Hospital — Hobart, Tasmania, Australia (enrolling)
• Linear Clinical Research — Perth, Western Australia, Australia (enrolling)
• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• Istituto Nazionale Oncologico Candiolo — Candiolo, Italy (enrolling)
• Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale San Raffaele — Milan, Italy (enrolling)
• Istituto Europeo Clinico Humanitas — Milan, Italy (enrolling)
• Istituto Europeo di Oncologia — Milan, Italy (enrolling)
• Institut Catala D&#39;Oncologia — Badalona, Spain (enrolling)
• Hospital Universitario Quironsalud Madrid — Madrid, Spain (enrolling)
• University of Maryland Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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