Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

The subjects will be initially enrolled in the lymphodepletion cohort. Subsequent subjects will be enrolled in the non-lymphodepletion cohort after reviewing the data in the lymphodepletion cohort.

up to 3 times CT048 Autologous Injection infusion

CT048 Autologous Injection (CT048)

lin Shen, MD,phD

Changsong Qi, MD, PhD

Lin Shen, MD

Yanshuo Cao, MD

Lin Shen, MD,phD

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.

Claudin18.2-redirected Chimeric Antigen Receptor T Cells With Co-expression of Cytokines in Solid Tumors

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

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.

CAR-CLDN18.2 DNA in peripheral blood detected by q-PCR at each visit after each infusion

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

The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause

The number of cases in which response are achieved from the start of cell infusion/the total number of evaluable cases (%).

The period from the date of leukapheresis to the first recorded tumor progression or death of any cause, whichever occurs first (ITT).

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Claudin18.2-redirected Chimeric Antigen Receptor T Cells With Co-expression of Cytokines in Solid Tumors	NCT05393986	Gastric Adenoca... Pancreatic Canc... Gastroesophagea...	CT048 Autologou...	18 Years - 75 Years	Peking University
Claudin18.2-redirected Chimeric Antigen Receptor T Cells With Co-expression of Cytokines in Solid Tumors	NCT05393986	Gastric Adenoca... Pancreatic Canc... Gastroesophagea...	CT048 Autologou...	18 Years - 75 Years	Peking University

Spots Global Cancer Trial Database for ct048 autologous injection (ct048)