OncoMatch/Clinical Trials/NCT07260812
KSV01 Injection for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Is NCT07260812 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive expression (positive)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT07260812 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior corticosteroid, chemotherapy, anti-graft-versus-host disease (GvHD) therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
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 qualifyRelated pages