An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects with Advanced Solid Tumors
This is an open-label, single-arm, dose-escalation and dose-expansion, single/multiple infusion(s) exploratory study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of CT048 in patients with advanced CLDN18.2+ solid tumors who had failed to at least 1 prior line of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
up to 3 times CT048 Autologous Injection infusion
Beijing Cancer Hospital, Beijing, China
Beijing, China
RECRUITINGDose-limiting toxicity (DLT)
Safety
Time frame: 28 days of single infusion
Maximum tolerated dose
Tolerability
Time frame: 28 days of single infusion
Nature, incidence, severity and seriousness of TEAEs, TRAEs and AESI; graded according to the NCI-CTCAE (Version 5.0) or ASTCT
Adverse events occurring through 24 weeks and 12 months post CT048 indusion, such as abnormalities or changes in laboratory tests, physical examinations, vital signs, etc.
Time frame: 1 year
Pharmacokinetics(the number of CAR copies and CAR persistence duration in peripheral blood)
CAR-CLDN18.2 DNA in peripheral blood detected by q-PCR at each visit after each infusion
Time frame: 1 year
Antitumor efficacy-Overall response rate (ORR), Duration of response (DOR), Disease control rate (DCR)
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%). In the event of PR or CR, the subjects should confirm it no less than 6 weeks after the first evaluation
Time frame: 1 year
Antitumor efficacy-Duration of response (DOR)
The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause
Time frame: 1 year
Antitumor efficacy-Disease control rate (DCR)
The number of cases in which response are achieved from the start of cell infusion/the total number of evaluable cases (%).
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Time frame: 1 year
Antitumor efficacy-Progression-free survival
The period from the date of leukapheresis to the first recorded tumor progression or death of any cause, whichever occurs first (ITT).
Time frame: 1 year
Antitumor efficacy-Overall survival (OS)
The period from the date of leukapheresis to death of any cause (ITT). The period from the date of first CT048 infusion to death of any cause (mITT).
Time frame: 2 years