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

TCRx Therapeutics Co.Ltd1 site in 1 country18 target enrollmentSeptember 1, 2025

ConditionsDiffuse Large B Cell Lymphoma (DLBCL)

InterventionsKSV01 Injection

DrugsKSV01 Injection

Overview

Phase: Phase 1
Intervention: KSV01 Injection
Conditions: Diffuse Large B Cell Lymphoma (DLBCL)
Sponsor: TCRx Therapeutics Co.Ltd
Enrollment: 18
Locations: 1
Primary Endpoint: Dose-limiting Toxicity
Status: Recruiting
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2025

End Date

December 31, 2028

Last Updated

19 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

TCRx Therapeutics Co.Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 ≤
•Life expectancy \> 3 months.
•KPS score ≥
•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 Criteria

•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.
•Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
•HIV infection.
•Positive for Treponema pallidum(syphilis).
•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).
•Participation in any other clinical trial within 4 weeks prior to enrollment.
•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.

Arms & Interventions

KSV01 Injection

KSV01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries CD19 CAR.

Intervention: KSV01 Injection

Outcomes

Primary Outcomes

Dose-limiting Toxicity

Time Frame: 28 days after administration

DLT evaluation period: The DLT evaluation period is defined as within 28 days (inclusive) after the subjects' first administration of KSV01 injection during the dose escalation stage. All adverse events should be graded and evaluated in accordance with CTCAE v5.0. Among them, cytokine release syndrome (CRS) and immune effector cell-related neurotoxicity syndrome (ICANS) should be determined and graded in accordance with the standards of the American Society for Transplantation and Cell Therapy (ASTCT).