Actively Recruiting
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Led by TCRx Therapeutics Co.Ltd · Updated on 2026-04-13
18
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
T
TCRx Therapeutics Co.Ltd
Lead Sponsor
T
Tongji Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients or their legal guardians voluntarily participate and provide written informed consent
- Age between 18 and 80 years, male or female
- ECOG performance status score of 1 or less
- Life expectancy greater than 3 months
- Karnofsky Performance Status score of 70 or higher
- Diagnosed with diffuse large B-cell lymphoma (DLBCL) as relapsed or refractory after at least one prior systemic therapy
- CD19 positivity confirmed by flow cytometry and/or histopathology
- Presence of PET-positive target lesions for tumor assessment based on Lugano 2014 criteria (Deauville 5-Point Scale score 4 or higher)
- Adequate organ function
- Female patients of childbearing potential have a negative pregnancy test at screening and agree to use effective contraception for at least 1 year after infusion
- Male subjects with partners of childbearing potential agree to use effective barrier contraception for at least 1 year after infusion
You will not qualify if you...
- History of another primary malignancy not in continuous remission for at least 2 years, except specified low-risk cancers
- Uncontrolled infectious disease within 4 weeks before enrollment
- Active hepatitis B or hepatitis C infection
- HIV infection
- Positive for syphilis (Treponema pallidum)
- Severe autoimmune disease or immunodeficiency except well-controlled Type I diabetes and thyroid disorders
- History of severe allergy or hypersensitivity to macromolecular biologic agents
- Participation in another clinical trial within 4 weeks before enrollment
- Significant central nervous system diseases such as epilepsy, stroke, dementia, Parkinson's disease, or others
- Isolated CNS involvement by lymphoma or ongoing CNS condition preventing accurate neurological evaluation
- Severe cardiovascular conditions within the past 6 months
- Presence of psychiatric illness
- History of drug abuse or addiction
- Use of corticosteroids (except physiologic replacement and topical/inhaled), chemotherapy, GvHD therapy, allogeneic stem cell transplantation, or gene therapy
- Women who are breastfeeding
- Unlikely to complete all study visits or comply with study requirements as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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