GC511B CAR-T Cell

This product is a lentiviral gene-modified autologous chimeric antigen receptor T-cell product that GC511B.Administration of GC511B CAR T-Cells a dose levels of DL1,DL2,DL3 and DL4 are administrated for each trial participants.Single IV infusion.

This is a First-in-Human, open-label, early dose-escalation clinical study to evaluate the safety and preliminary efficacy of GC511B CAR T cell injection in Adult with DLL3+ r/r SCLC trial participants. this study consists of two parts: dose escalation and dose expansion: Dose Escalation: This part consists of two stages:Stage 1: Accelerated titration design to explore the effective starting dose;Stage 2: Bayesian optimal interval (BOIN) design to explore the MAD/MTD.The BOIN design will start with aDL1 as determined in Stage 1 and continue until either 9 trial participants have been enrolled at a single dose level (DL) or the total number of trial participants reaches 11.Starting with BOIN stage DL3, the first and second trial participants were reinfused at least 2 weeks apart.During the dose-escalation phase, following each dose level (DL) and/or scheduled infusion time point, the Safety Review Committee (SRC) will evaluate all adverse events (AEs), serious adverse events (SAEs), laboratory safety data from subjects in the DLT observation period, as well as all other relevant available data, to determine the next DL to be explored and/or dosing schedule and to provide recommendations for subsequent study conduct.

Dose expansion : The dose expansion phase will be initiated at the defined RDE to further investigate the safety, feasibility, CK, immunogenicity, PD, and preliminary antitumor activity of GC511B monotherapy and/or combination therapy. Up to 4 expansion cohorts may be opened to evaluate specific DLs and indications with up to 20 response-evaluable trial participants included in each cohort.

This is a First-in-Human, open-label, early dose-escalation clinical study to evaluate the safety and preliminary efficacy of GC511B CAR T cell injection in Adult with DLL3+ r/r SCLC trial participants.

Live record on ClinicalTrials.gov →

• 1.Trial articipant must be ≥ 18 years and ≤75 years of age at the time of signing the ICF.
• Type of Subjects and Disease Characteristics
• 2.ECOG performance status 0-2.
• 3.Life expectancy ≥ 12 weeks.
• 4.At least 1 TL meeting RECIST v1.1 at screening. Tumor assessment by CT scan or MRI must be performed within 28 days prior to apheresis.
• A lesion can be considered TL if the lesion previously subjected to radiotherapy has a clear boundary, is measurable as per RECIST v1.1, and has clear progression during or after the latest treatment;

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.