OncoMatch/Clinical Trials/NCT05365659
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
Is NCT05365659 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies IKS03 for b-cell non-hodgkin lymphoma.
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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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
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 →Frequently asked questions
Is NCT05365659 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD19-targeted therapy, tumor vaccine, CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Are patients with CD19 alterations eligible?
No. CD19 negative is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify