NCT06728189

A Clinical Research About CD70-targeted CAR-NKT Cells Therapy in Subjects with Advanced Malignant Solid Tumors

A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects with Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced malignant solid tumors. Condition or disease：advanced malignant solid tumors Intervention/treatment：Biological: CD70 CAR-NKT cells Phase：Phase 1

Detailed description

This was a dose-expansion study, we plan to enroll 13 to 23 patients with CD70-positive advanced malignant solid tumors to CGC738 treatment. The study was conducted in two stages: dose escalation and dose expansion. Dose escalation involved three dose groups, which were administered using a rapid titration approach combined with the "3+3" design. Revised sentence: "One subject will be enrolled in the initial dose group, and if no dose-limiting toxicity (DLT) occurs within 28 days of the first administration, three additional subjects will be recruited into the subsequent predetermined escalating dose group. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. Dose exploration can be discontinued once one or more dose levels with an acceptable safety profile and satisfactory antitumor activity have been selected for subsequent evaluation. During the treatment period of the study, three dose levels of CGC738 will be evaluated. Each of the dose levels will evaluate the safety of the CAR-NKT cells. The extended study is anticipated to enroll a cohort of 6 to 10 participants. We used leukapheresis for cell collection. The lymphodepletion procedure was conducted using a combination of fludarabine and cyclophosphamide.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	CAR-NKT Cells treatment	Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells Lymphodepleting regimen, Cyclophosphamide 250mg/m2 IV on day -5 to -3 and Fludarabine 25mg/m2 IV on days -5 to -3. Followed by infusion of CAR-NKT on day 0. Potential CGC738 doses: Dose level 1: 5.0×106 CAR- NKT cells/m2; Dose level 2: 1.5×107 CAR- NKT cells/m2; Dose level 3: 4.5×107 CAR- NKT cells/m2;

Timeline

• Start date: 2024-11-14
• Primary completion: 2026-10-17
• Completion: 2026-10-17
• First posted: 2024-12-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: China