Recruiting NCT07260812
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KSV01 Injection.
- Who it may be relevant to
- Registry conditions: Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KSV01 Injection in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Overview
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.
Interventions
- Drug KSV01 Injection
KSV01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries CD19 CAR.
Primary outcome measures
- Dose-limiting Toxicity [Time frame: 28 days after administration]
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 ≤ 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 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.
- History of severe cardiovascular conditions within the past 6 months.
- Presence of psychiatric illness.
- History of drug abuse or addiction.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology — Wuhan
Identifiers
NCT: NCT07260812 · KSV01-R101