KSV01 injection for diffuse large B-cell lymphoma that returned or did not respond

Trial details

Who runs it

TCRx Therapeutics Co.Ltd

Trial code

NCT07260812

Record updated

26 October 2026

Original description

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 diffuse large B-cell lymphoma.Read full original descriptionShow less

A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KSV01 Injection in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

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 diffuse large B-cell lymphoma.

Inclusion: Patients or their legal guardians voluntarily participate in the study and provide written informed consent; Aged 18 to 80 years (inclusive), male or female; ECOG performance status score of ≤ 1; Life expectancy > 3 months; KPS score ≥ 70; Patients with diffuse large B-cell lymphoma (DLBCL) diagnosed according to the 2016 WHO classification. Patients with DLBCL should have been diagnosed as relapsed or refractory after at least one prior line of systemic therapy; CD19 positivity confirmed by flow cytometry and/or histopathology; According to the Lugano 2014 criteria, the presence of PET-positive target lesions for tumor assessment is required (Deauville 5-Point Scale [5-PS] ≥ 4); Adequate organ function; Female patients of childbearing potential must have a negative urine/blood pregnancy test during the screening period and agree to use effective contraception for at least 1 year after infusion; male subjects with partners of childbearing potential must agree to use effective barrier contraception for at least 1 year after infusion.

Exclusion: History of another primary malignancy that has not been in continuous remission for at least 2 years, except for the following conditions which are exempt from the 2-year limit: non-melanoma skin cancer, Stage I solid tumors treated with curative intent and low risk of recurrence, cured localized prostate cancer, biopsy-confirmed carcinoma in situ of the cervix, or squamous intraepithelial lesion identified on Pap smear; Uncontrolled infectious disease within 4 weeks prior to enrollment; Participation in any other clinical trial within 4 weeks prior to enrollment; Use of the following medications or therapies:; Corticosteroids (physiologic replacement doses, and topical or inhaled steroids are permitted); Chemotherapy; GvHD Therapy; Allogeneic hematopoietic stem cell transplantation; Gene therapy; Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; HIV infection; Severe autoimmune disease or immunodeficiency, with the exception of well-controlled Type I diabetes and thyroid disorders; History of severe allergy or hypersensitivity to macromolecular biologic agents (e.g., antibodies, cytokines); History of clinically significant central nervous system (CNS) diseases, including but not limited to epilepsy, paresis, aphasia, stroke, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome; Presence of isolated CNS involvement by lymphoma, or any ongoing CNS condition that precludes accurate neurological evaluation; History of severe cardiovascular conditions within the past 6 months; Presence of psychiatric illness; History of drug abuse or addiction; Positive for Treponema pallidum(syphilis); Women who are breastfeeding; In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures (including follow-up visits) or unlikely to comply with the requirements for participation in this study.

ClinicalTrials.gov NCT07260812