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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
KSV01 Injection
DrugKSV01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries CD19 CAR.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: KSV01 InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting Toxicity
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).
Time frame
28 days after administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
TCRx Therapeutics Co.Ltd
Lead sponsor
Tongji Hospital
Collaborator
Source ClinicalTrials.gov