OncoMatch/Clinical Trials/NCT07260812
KSV01 Injection for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Is NCT07260812 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies KSV01 for non-hodgkin lymphoma.
Treatment: KSV01 — This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 Injection for patients with B-cell non-hodgkin lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive expression (positive)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: corticosteroid (prednisone)
Exception: physiologic replacement doses, and topical or inhaled steroids are permitted
Therapeutic doses of corticosteroids (defined as prednisone or equivalent >20 mg/day) within 72 hours prior to study drug infusion
Cannot have received: chemotherapy
Salvage chemotherapy within 2 weeks prior to study drug infusion
Cannot have received: anti-graft-versus-host disease (GvHD) therapy
Anti-graft-versus-host disease (GvHD) therapy within 4 weeks prior to study drug infusion
Cannot have received: allogeneic hematopoietic stem cell transplantation
Allogeneic hematopoietic stem cell transplantation
Cannot have received: gene therapy
Gene therapy
Cannot have received: adoptive cell therapy
Adoptive cell therapy
Cannot have received: anti-CD52 antibody (alemtuzumab)
Prior treatment with alemtuzumab within 6 months
Cannot have received: purine analog (cladribine, clofarabine)
cladribine or clofarabine within 3 months prior to study drug infusion
Cannot have received: radiation therapy
Exception: To be eligible, lesions within the radiation field must have shown disease progression (PD), or the patient must have PET-positive lesions outside the radiation field. If PET-positive lesions exist outside the radiation field, radiotherapy to other lesions must have been completed at least 2 weeks prior to the first study drug dose.
Radiotherapy within 6 weeks prior to signing informed consent
Lab requirements
Kidney function
Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min
Liver function
ALT ≤ 5x ULN and total bilirubin < 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome or documented lymphomatous infiltration of the liver)
Cardiac function
LVEF ≥ 40% by echocardiography, absence of significant pericardial effusion, and no clinically significant ECG abnormalities
Adequate organ function: Hepatic function: ALT ≤ 5x ULN and total bilirubin < 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome or documented lymphomatous infiltration of the liver); Renal function: Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min; Pulmonary function: Oxygen saturation (SaO₂) ≥ 92% on room air, and no active pulmonary infection; Cardiac function: LVEF ≥ 40% by echocardiography, absence of significant pericardial effusion, and no clinically significant ECG abnormalities.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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