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).

CARsgen Therapeutics Co., Ltd.

Peking University

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunoglobulins

Immunologic Factors

The subjects enrolled will be sequentially assigned to the corresponding dose level.

CT041 monotherapy in patients with GI cancers who failed standard chemotherapy

CT041 plus anti-PD1 therapy in patients with GI cancers who failed standard chemotherapy

CT041 sequential treatment after first-line therapy in GC/GEJ

prior treatment failure to anti-CLDN18.2 monoclonal antibody

Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses

• Chimeric Antigen Receptor T Cells Targeting Claudin18.2

CAR-CLDN18.2 T-Cells

Chimeric Antigen Receptor T Cells Targeting Claudin18.2 with PD-1

PD-1 Monoclonal Antibody

First-line systemic therapy according to physician's choice

Chemotherapy

Lin Shen

An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.

This study is an open, single/multiple infusion, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of CAR-CLDN18.2 T cell therapy, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with positive claudin 18.2 expression and failed to standard systemic treatment.

Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.

An Open Label, Single/Multiple Dose Exploratory Clinical Study to Evaluate the Safety, Efficacy, and Cytokinetics of Autologous Humanized Anti-claudin18.2 Chimeric Antigen Receptor T Cell in Advanced Solid Tumor Subjects

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

Adverse events occurring through 26 weeks and 12 months post infusion of CAR-CLDN18.2 T-Cell infusion, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.

The period from the day when the subject receives the infusion of cells to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first.

The period from the first evaluation of clinical benefit to the first evaluation of PD or any cause of death.

The period from the first infusion to any cause of death

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 4 weeks after the first evaluation

Professor

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Cancer

TORL-2-307-MAB

Stephen Letrent, PharmD, PhD

David J Park, MD

Zev Wainberg, MD

Hugo Hool, MD

Sunil Babu, MD

Tae Yong Kim

Sun Young Rha

Keun Wook Lee

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-MAB in patients with advanced cancer

First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer

A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-MAB in Participants With Advanced Cancer

Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1

Time from CR or PR to objective disease progression or death to any cause

PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause

Time from start of treatment to complete response or partial response

Proportion of participants alive at 1 year from the start of treatment to death from any cause

Proportion of participants alive at 2 years from the start of treatment to death from any cause

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

Translational Research in Oncology

TORL Biotherapeutics, LLC

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

TORL-2-307-ADC

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer

First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer

A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Camurati-Engelmann Disease

Immunomodulating Agents

Patients will receive 3 or more cycles of the CAR-T cells treatment via systemic or regional injection, from 1x10e6/kg-10x10e6/kg weight.

CAR-T cells injection: (1-10×10e6/kg CAR-T for each treatment; 3 or more cycles.

CAR-T cells targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR

Zhenfeng Zhang, MD,PhD

Peng Li, PhD

Xianhong Xiang, MD,PHD

Yonghui Huang, MD,PHD

Deji Chen, MD,PhD

The third generation of CAR-T cells that target GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR have been constructed respectively and their anti-cancer function has been verified by multiple in vitro and in vivo studies.Clinical studies will be performed to test the anti-cancer function of the these individual or combination of the CAR-T cells for immunotherapy of human cancer patients with GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR

-CAR-T cell immunotherapy on human cancers will firstly be tested.

1. Choose appropriate patients with advanced lung or other cancers,with written consent for this study;
2. Perform biopsy to determine the expression of HER2, Mesothelin, Lewis-Y, PSCA, MUC1, GPC3, AXL, EGFR, Claudin18.2, or B7-H3 of the tumor by western blotting or IHC;
3. Collect blood from the patients and isolate mononuclear cells, activate the T cells and transfect the T cells with GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR targeting CAR, amplify the transfected T cells as needed, test the quality and killing activity of the CAR-T cells and then transfer them back the patients via systemic or local injections, and follow up closely to collect related results as needed;
4. To enhance the killing capability, CD4+ T cells are genetically engineered to express TGFβ-CAR and secret IL7/CCL19 and/or SCFVs against PD1/CTLA4/Tigit; CD8+T cells are constructed to express GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR

   -DAP10-CAR with knockdown of PD1/HPK1;
5. Other cancers with these cell surface antigen expressions are also recruited if needed;
6. Evaluate the clinical results as needed.

Use engineered CAR-T cells to kill cancer cells with certain targets.

GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T Cells Against Cancers

CAR-T Targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR for Immunotherapy of Lung Cancer: Phase I Clinical Trial

A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR T cells,which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.

Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.

Median CAR-T cell persistence will be measured by quantitative rt-PCR.

Hunan Zhaotai Yongren Medical Innovation Co. Ltd.

Guangdong Zhaotai InVivo Biomedicine Co. Ltd.

Second Affiliated Hospital of Guangzhou Medical University

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Paclitaxel

Irinotecan

Apatinib

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.	NCT03874897	Advanced Solid ...	CAR-CLDN18.2 T-... PD-1 Monoclonal... Chemotherapy	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
First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer	NCT05159440	Advanced Solid ... Gastric Cancer Pancreas Cancer Gastroesophagea...	TORL-2-307-MAB	18 Years -	TORL Biotherapeutics, LLC
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.
First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer	NCT05156866	Advanced Solid ... Gastric Cancer Pancreas Cancer Gastroesophagea...	TORL-2-307-ADC	18 Years -	TORL Biotherapeutics, LLC
First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer	NCT05159440	Advanced Solid ... Gastric Cancer Pancreas Cancer Gastroesophagea...	TORL-2-307-MAB	18 Years -	TORL Biotherapeutics, LLC
First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer	NCT05159440	Advanced Solid ... Gastric Cancer Pancreas Cancer Gastroesophagea...	TORL-2-307-MAB	18 Years -	TORL Biotherapeutics, LLC
GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T Cells Against Cancers	NCT03198052	Lung Cancer Cancer Immunotherapy CAR-T Cell	CAR-T cells tar...	18 Years - 75 Years	Second Affiliated Hospital of Guangzhou Medical University
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 claudin18.2

Every month we try and update this database with for claudin18.2 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 claudin18.2

Every month we try and update this database with for claudin18.2 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 claudin18.2 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.