KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTCRx Therapeutics Co.Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- KSV01 Injection
Treatment groups
18 Participants
are divided into 1 treatment groupLocations
1Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology WuhanHubei, China
Sponsors and collaborators
TCRx Therapeutics Co.Ltd
Lead sponsor
Tongji Hospital
Collaborator
Source ClinicalTrials.gov