Clinical trial NCT06616727: The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the rGBM
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SNC109 in Patients With Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Recurrent Glioblastoma Multiforme (GBM)
Keywords: GBM
Lead sponsor: Shanghai Simnova Biotechnology Co.,Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM

Detailed description: It is planned to recruit about 50 patients with rGBM subjects. The protocol consists of screening period, Lymphocytes apheresis period, Operation period, pre-infusion evaluation (-2\~-1 days), infusion (day 0), infusion observation (day 1-post infusion), and follow-up period (last infusion-720 days). The incidence of dose limitation toxicity (DLT) will be observed within 28 days after the first infusion. Subjects in this study will receive multiple infusions, starting with 5×104 CAR+ T cells/dose in the first subject, and the Safety Review Committee (SRC) will evaluate the subsequent dosing regimen, dose, infusion interval, and number of treatment cycles. Subsequent subjects will be evaluated by the SRC on the basis of available PK and safety data, and the SRC will determine the dosing regimen, dose, infusion interval and number of treatment cycles based on observed evidences.

Eligibility criteria: Inclusion Criteria:

* Age ≥18，both sexes;
* Diagnosed with a history of glioblastoma, and the recurrent glioblastoma has confirmed by histological/molecular pathology (including astrocytoma World Health Organization (WHO) Grade 4);
* Karnofsky (KPS) ≥50;
* The estimated survival time is ≥12 weeks;
* Blood pregnancy tests for women of childbearing age are negative;
* The patient himself/herself, and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form.

Exclusion Criteria:

* Known allergies to study drugs or drugs that may be used in the study;
* Severe concurrent diseases in the heart, lungs, liver, or other vital organs;
* Hypertension is poorly controlled or accompanied by hypertensive crisis or hypertensive encephalopathy;
* In addition to the glioblastoma, with other severe central nervous system diseases or complications or aggressive malignancies;
* Long-term use of immunosuppressant drugs, or large doses of steroids;
* Received live or attenuated vaccine or other surgery had no related to GBM within 4 weeks prior to Lymphocytes apheresis;
* Lymphocytes apheresis or cell infusion combined with infection or unexplained fever.

Primary outcomes:
measure: Incidence of treatment related adverse events
timeFrame: Up to 28 days after first infusion
measure: DLT
timeFrame: Up to 28 days after first infusion
Secondary outcomes:
measure: Overall survival (OS) after infusion
timeFrame: within 2 years after first infusion
measure: Time maximum of SNC-109 Cell count and CAR vector copy number
timeFrame: within 2 years after first infusion
measure: Pharmacokinetic (PK) profile/parameters Peak Plasma Concentration (Cmax) of SNC-109 Cell count and CAR vector copy number
timeFrame: within 2 years after first infusion
measure: Pharmacokinetic (PK) profile/parameters Area under the plasma concentration versus time curve (AUC)
timeFrame: within 2 years after first infusion
measure: Progression free survival (PFS) after infusion
timeFrame: within 2 years after first infusion
measure: Efficacy assesment for the treatment according to iRANO
timeFrame: within 2 years after first infusion
measure: Pharmacodynamic (PD) profile/parameters Changes of Cytokines after infusion
timeFrame: within 2 years after first infusion
measure: Concentration of Human anti-chimeric antibody (HACA)
timeFrame: within 2 years after first infusion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References: