Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Stomach Neoplasms

Pancreatic Neoplasms

Stomach Cancer

Pancreatic Cancer

Each subject will receive KD-496 cell infusion

Autologous genetically modified anti-NKG2DL/CLDN18.2 CAR transduced T cells

KD-496

jianming Xu

This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D/CLDN18.2-based CAR-T cells infusion in the treatment of advanced NKG2DL+/CLDN18.2+ solid tumors.

This is an open-label, dose escalation/expansion study to assess the safety,tolerability, and efficacy of KD-496 cell infusion in patients with advanced NKG2DL+/CLDN18.2+ solid tumors. In this study, the enrollment of the patients must meet the inclusion and exclusion criteria. All subjects will be undergo screening, pre-treatment (cell product preparation, lymphodepleting chemotherapy), treatment and follow up.

NKG2D/CLDN18.2 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors

A Single-center, Open-label, Single-arm Clinical Study of the Safety and Efficacy of KD-496 CAR-T Therapy in Advanced NKG2DL+/CLDN18.2+ Solid Tumors

An adverse event is any undesirable experience associated with the use of a medical product in a patient

A drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.

The time of CAR-T cell reach the peak and turn back to baseline

objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1

the time from the date of first infusion of the KD-496 to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first

the time from the date of first infusion of KD-496 to death of the subject

KAEDI

jianming xu

Leading Site Principal Investigator

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Oxaliplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Pancreatic cancer participants will be treated with QLS31905 in combination with nab-paclitaxel and gemcitabine for part A of the study to establish the recommended dose of QLS31905 for part B. In part B, the participants will be treated with QLS31905 at a dose determined by the part A of the study in combination with nab-paclitaxel and gemcitabine.

In part B, gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at dose determined by part A of the study in combination with oxaliplatin and capecitabine.

In part B, other solid tumor participants including but not limited to biliary tract cancer will be treated with QLS31905 at dose determined by part A in combination with standard chemotherapy recommended by guidelines.QLS31905 plus gemcitabine+ cisplatin as the first-line treatment of advanced biliary tract cancer.

QLS31905

125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.

Nab paclitaxel

1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.

85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.

1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.

25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.

Lin Shen, M.D

This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors

A Phase IB/II Clinical Study to Assess the Efficacy and Safety of QLS31905 in Combination With Chemotherapy as First-line Treatment in Patients With Claudin 18.2 (CLDN18.2) Positive Advanced Malignant Solid Tumors

As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.

Monitor for MTD, and minimal efficacious dose by monitoring responses at different dose levels.

ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.

An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product.

Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect,hospitalization, or medically important event.

Number of participants with potentially clinically significant laboratory values.

PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).

DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).

OS is defined as the duration from the first dose of the investigational product to the time point when death occurs due to any cause.

Cmax will be derived from the PK serum samples collected.

Tmax will be derived from the PK serum samples collected.

T1/2 will be derived from the PK serum samples collected.

CL will be derived from the PK serum samples collected.

Vz will be derived from the PK serum samples collected.

Immunogenicity will be measured by the number of participants that are ADA positive.

Qilu Pharmaceutical Co., Ltd.

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Immunoglobulins, Intravenous

Immunologic Factors

AB011 Injection treatment. This phase 1 trial will include two stages, a single treatment stage and a Combo treatment stage.

Stage 1 Single treatment: AB011 Injection with dose escalation of 1mg/kg up to 40mg/kg, as well as dose expansion with recommended dose level from dose escalation.

Stage 2 Combo Treatment: AB011 combine XELOX( GC) or Gem/nab-P (PC) Injection with dose escalation of 10mg/kg up to 30mg/kg, as well as dose expansion with recommended dose level from dose escalation.

AB011 Injection

Jin Li

This is an open, two-stage, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AB011 injection in patients with CLDN18.2-positive advanced solid tumors.

This study is an open, two-stage, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AB011 injection in patients with CLDN18.2-positive advanced solid tumors. The study is composed of two stages: stage I is single treatment and stage II is combo treatment.

Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors

An Open, Two-stage, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors

An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

AUC will be recorded from the PK serum samples collected.

These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.

Shanghai East Hospital

CARsgen Therapeutics Co., Ltd.

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Experimental: anti-claudin18.2 chimeric antigen receptor T-cell therapy Phase 1b: Evaluate the efficacy and safety of CT041

Treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion. Up to 3 times CT041 autologous CAR T-cell injection infusion

CT041 autologous CAR T-cell injection

Lifeng Zhang

Ning Wang

Lin Shen, PhD

Xiaobing Chen, Ph.D

Heshui Wu, Ph.D

Wei Cheng, Ph.D

Jun Zhang, Ph.D

Xianjun Yu, Ph.D

Jian Zhang, Ph.D

Zheng Wu

Yiping Mou, Ph.D

An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of CT041 Autologous CAR T Cell Injection after adjuvant chemotherapy in subjects with pancreatic cancer.

This study is an open, multicenter, Phase Ib clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive pancreatic cancer who has undergone adjuvant chemotherapy. The aim of this study is to evaluate the efficacy, safety of CT041 treatment.

A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer

An Open-label, Single-arm, Multicenter, Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of CT041 Autologous CAR T Cell Injection After Adjuvant Chemotherapy in Subjects With Pancreatic Cancer

The time from the first infusion to the occurrence of local recurrence/distant metastasis or death from any cause, whichever occurred first.

An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Proportion of patients alive without local recurrence/distant metastasis 1 year after the first infusion.

The time from the first infusion to the occurrence of any pancreatic cancer distant metastases or death from any cause, whichever occurred first.

The time from the first infusion to death of the subject from any cause.

Peak cell expansion, peak expansion, area under the curve (AUC), and duration of cell survival after infusion of CT041 cells.

Drug antibody (ADA) positive rate after infusion of CT041 cells.

Fudan University

Radiopharmaceuticals

68Ga-PMD22 PET/CT scan Dosimetry study about 6 patients were injected with 2-4 (MBq) per kilogram body weight of 68Ga-PMD22 PET/CT in one dose intravenously and underwent wholebody scan at 5min#15min#30min#60min#90min#120min#180min, then analysis of dosimetric distribution of radiopharmaceuticals in human body by HERMES software.

After the dynamic scan completed, choose an optimal imaging examination time for PET examination of other patients.

68Ga-PMD22 were intravenous injected into the patients before PET/CT scans

Intravenous injection of 68Ga-PMD22

Rongxi Wang

Zhaohui Zhu

To investigate the ability of the CLDN18.2-targeted 68Ga-PMD22 tracer to detect CLDN18.2 expression in patients with gastric and colorectal cancer and other gastrointestinal tumours.

The 2016 FAST study brought a "new star" target for gastric cancer - CLDN18.2 (claudin 18 splice variant 2,CLDN18.2), which belongs to the CLDN family of tight junction proteins and is involved in the formation of paracellular tight junctions and maintenance of cell polarity. CLDN18.2 is mainly found in the normal gastric mucosa (normal gastric glands, principal cells, mural cells, endocrine cells) where the differentiation cycle is short and renewal is rapid, and in the duodenal panniculocytes, but not in the gastric stem cell region. It is now generally accepted that CLDN18.2 is expressed in normal gastric tissue confined to the tight junctions at the outer base of the gastric mucosal cells, whereas tumours undergo a change in cell polarity during malignant transformation, resulting in widespread exposure of CLDN18.2 to the cell membrane surface. The CLDN18.2 gene is also aberrantly activated and highly specific and stably expressed in specific tumour tissues, participating in the proliferation, differentiation and migration of tumour cells, making it a potentially effective target for anti-tumour drugs.

In this study, a molecular probe PMD22 targeting CLDN18.2 was synthesised in a previous study and a 68Ga-PMD22 injection was developed for clinical trials. The preliminary study showed that the tracer has good safety and good imaging effect. It is proposed to further conduct exploratory PET/CT imaging studies on patients with gastric cancer, colorectal cancer and other gastrointestinal tumours, to provide a new technique for in vivo, non-invasive and visual detection of CLDN18.2 expression level and spatial distribution for patients with gastric cancer, colorectal cancer and other gastrointestinal tumours, and to validate its clinical application value for the diagnosis of gastric cancer, colorectal cancer and other gastrointestinal tumours.

68Ga-PMD22 PET/CT Examination Targeting CLDN18.2

CLDN18.2 Targeted 68Ga-PMD22 PET Imaging in Patients With Gastrointestinal Tumours

Input the 68Ga-PMD22 PET data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software

The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured. SUV were obtained by a self-made software and referring to phantom study.If the SUV value cannot be obtained, the COUNTS of target organ/background ratio between the lesion and surrounding tissues shall be used for calculation.

Adverse events within 1 week after the injection and scanning of patients and patients will be followed by phone call and assessed the safety of 68Ga-PMD22, including blood pressure, blood function, liver and kidney function data, gastrointestinal reactions.

Peking Union Medical College Hospital

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Irinotecan

Apatinib

Topoisomerase I Inhibitors

Enzyme Inhibitors

Protein Kinase Inhibitors

Two stages: Phase 1b: dose escalation and dose expansion; Phase 2: verify CT041 efficacy and safety

Participants will receive physician's choice of treatment in Phase II

Up to 3 times CT041 autologous CAR T-cell injection infusion

Physician's choice of any BSC listed above

Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody）

Lifeng Zhang, MD

Changlu Hu, Professor

Shen Lin, PhD

Xiaoyan Lin, Professor

Shubing Wang, Professor

Yanqiao Zhang, Professor

Ning Li, Professor

Yanru Qin, Professor

Xianglin Yuan, Professor

Jia Wei, Professor

Zhixiang Zhuang

Xizhi Zhang, Professor

Anwen Liu, Professor

Jiuwei Cui, Professor

Xiujuan Qu, Professor

Zuoxing Niu, Professor

Wensheng Qiu, Professor

Jun Zhang, Professor

Xianjun Yu, Professor

Jian Zhang, Professor

Tianshu Liu, Professor

Tongyu Lin, Professor

Meng Qiu, Professor

Yi Ba, Professor

Weijia Fang, Professor

Hongming Pan, Professor

Lin Shen, Professor

An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer

This study is an open, multicenter, Phase Ib/II clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive, advanced gastric/esophagogastric conjugate adenocarcinoma that has failed at least 2 prior lines therapy and advanced pancreatic cancer that has failed at least 1 prior line therapy. The purpose is to evaluate the efficacy, safety and pharmacokinetics There are two stages in the study. Phase Ib stage is dose escalation and dose expansion study, and Phase II stage is to verify the efficacy and safety of CT041 treatment.

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

An Open, Multicenter, Phase Ib/II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection in Patients With Advanced Gastric/ Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer

Incidence of treatment related AEs, AEs of special interest and serious adverse events(SAEs).

Incidence of dose-limiting toxicities (DLTs)

Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.

Progression-free survival (PFS) was defined as the time from the date of first infusion of CT041 to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

Overall Survival (OS) was defined as the time from the date of first infusion of CT041 to the date of death due to any cause.

Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.

Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.

Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.

Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.infusion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NKG2D/CLDN18.2 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors	NCT05583201	Gastric Cancer Pancreatic Canc... Solid Tumor	KD-496	18 Years - 75 Years	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
NKG2D/CLDN18.2 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors	NCT05583201	Gastric Cancer Pancreatic Canc... Solid Tumor	KD-496	18 Years - 75 Years	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors	NCT06041035	Solid Tumor	QLS31905 Nab paclitaxel Gemcitabine Oxaliplatin Capecitabine Cisplatin	18 Years -	Qilu Pharmaceutical Co., Ltd.
A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors	NCT06041035	Solid Tumor	QLS31905 Nab paclitaxel Gemcitabine Oxaliplatin Capecitabine Cisplatin	18 Years -	Qilu Pharmaceutical Co., Ltd.
Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors	NCT04400383	Solid Tumor Gastric Cancer Pancreatic Aden...	AB011 Injection	18 Years - 80 Years	CARsgen Therapeutics Co., Ltd.
A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer	NCT05911217	Pancreatic Canc...	CT041 autologou...	18 Years - 79 Years	CARsgen Therapeutics Co., Ltd.
NKG2D/CLDN18.2 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors	NCT05583201	Gastric Cancer Pancreatic Canc... Solid Tumor	KD-496	18 Years - 75 Years	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
68Ga-PMD22 PET/CT Examination Targeting CLDN18.2	NCT05937919	Gastrointestina...	Intravenous inj...	- 80 Years	Peking Union Medical College Hospital
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection	NCT04581473	Gastric Adenoca... Pancreatic Canc... Gastroesophagea...	CT041 autologou... Physician's Cho...	18 Years - 75 Years	CARsgen Therapeutics Co., Ltd.

Spots Global Cancer Trial Database for cldn18.2

Every month we try and update this database with for cldn18.2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cldn18.2

Every month we try and update this database with for cldn18.2 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cldn18.2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.