OncoMatch/Clinical Trials/NCT05365659
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
Is NCT05365659 recruiting? Yes, currently enrolling (Sep 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 expression (positive)
confirmed CD19-positive
Excluded: CD19 expression
Patients documented to be CD19-negative
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status 0 or 1
Prior therapy
Must have received: systemic therapy
must have received at least 2 prior lines of systemic therapy
Cannot have received: autologous/allogeneic CAR-T 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: solid organ transplant
Prior solid organ transplant
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 ≥ 45 mg/g or ≥ 4.5 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 ms; Left ventricular ejection fraction below lower limit of normal or < 50% by MUGA/echo; Class III or IV NYHA; history of acute coronary syndromes, angioplasty, stenting, or bypass within 6 months
See exclusion criteria 5, 6, 7, 8, 10
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 autologous/allogeneic CAR-T therapy, solid organ transplant disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Are patients with CD19 alterations eligible?
No. CD19 expression 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