OncoMatch/Clinical Trials/NCT05365659

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

Is NCT05365659 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies IKS03 for b-cell non-hodgkin lymphoma.

Phase 1RecruitingIksuda Therapeutics Ltd.NCT05365659Data as of May 2026

Treatment: IKS03 — 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).

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Diffuse Large B-Cell Lymphoma

Biomarker criteria

Required: CD19 positive

confirmed CD19-positive

Excluded: CD19 negative

Patients documented to be CD19-negative

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Cannot have received: CD19-targeted therapy

Any CD19-targeted therapy within 3 months

Cannot have received: tumor vaccine

Exception: must have progressed if previously received

Any tumor vaccine within 6 weeks (must have progressed if previously received)

Cannot have received: CAR-T cell therapy

Exception: if known to be CD19-negative after

Prior autologous/allogeneic CAR-T therapy if known to be CD19-negative after

Cannot have received: antineoplastic agent

Exception: without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest (except nitrosoureas and mitomycin C within 6 weeks)

Any other antineoplastic agent for the primary malignancy without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest (except nitrosoureas and mitomycin C within 6 weeks)

Cannot have received: investigational treatment

Any other investigational treatments within 4 weeks

Cannot have received: NSAID

NSAIDS within 3 days

Cannot have received: aminoglycoside antibiotic

Aminoglycoside antibiotics, amphotericin B, etc. within 1 week

Cannot have received: bisphosphonate

Bisphosphonates within 1 month

Cannot have received: solid organ transplant

Prior solid organ transplant

Cannot have received: allogeneic HSCT

Exception: within 6 months, or if receiving immunosuppression, or if with active evidence of GVHD

Allogeneic HSCT within 6 months, or: If receiving immunosuppression; If with active evidence of GVHD

Cannot have received: autologous HSCT

Exception: within 3 months

Autologous hematopoietic stem cell transplantation (HSCT) within 3 months

Cannot have received: radiotherapy

Exception: to target lesions within 4 weeks unless progression of the lesion has been documented; to non-target lesions within 1 week

Radiotherapy: To target lesions within 4 weeks unless progression of the lesion has been documented; To non-target lesions within 1 week

Cannot have received: live/live-attenuated vaccine

Live/live-attenuated vaccines against infectious diseases within 4 weeks

Cannot have received: immunosuppressive or systemic glucocorticoid therapy

Exception: > 10 mg prednisone daily or equivalent within 2 weeks

Immunosuppressive or systemic glucocorticoid therapy (> 10 mg prednisone daily or equivalent) within 2 weeks

Cannot have received: hematopoietic growth factor

Exception: prophylactic use within 1 week

Prophylactic use of hematopoietic growth factors within 1 week

Cannot have received: herbal therapy or supplement

Exception: within 2 weeks

Herbal therapies and supplements within 2 weeks

Cannot have received: strong CYP450 inhibitor

Exception: within 2 weeks

Strong inhibitors of cytochrome P450 within 2 weeks

Lab requirements

Blood counts

Hemoglobin ≥ 8.0 g/dL; Absolute neutrophil count ≥ 1,000 per mm3; Platelet count ≥ 75,000 per mm3.

Kidney function

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.

Liver function

Total bilirubin ≤ 1.5 × ULN; ≤ 3 × ULN if with Gilbert's Syndrome. AST or ALT ≤ 3 × ULN; ≤ 5 × ULN if due to hepatic involvement by tumor.

Cardiac function

QTc interval < 480 milliseconds; Left ventricular ejection fraction ≥ lower limit of normal or ≥ 50% by MUGA scan or echocardiogram.

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 × 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. QTc interval ≥ 480 milliseconds; Left ventricular ejection fraction below the lower limit of normal or < 50% by MUGA scan or echocardiogram.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

University of Maryland Baltimore · Baltimore, Maryland

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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