Clinical Study of CAR-CLD18 T Cells in Patients With Advanced Gastric Adenocarcinoma and Pancreatic Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT03159819|
Recruitment Status : Unknown
Verified March 2018 by Bin Wang, Changhai Hospital.
Recruitment status was: Recruiting
First Posted : May 19, 2017
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Gastric Adenocarcinoma Pancreatic Adenocarcinoma||Genetic: CAR-CLD18 T Cells||Not Applicable|
For patients with gastric adenocarcinoma who have not been cured with first line chemotherapy, and who are not willing to undergo second line chemotherapy after the failure of first line chemotherapy while there are no effective therapies for their unmet medical needs known at this time, and for patients with advanced/metastatic pancreatic adenocarcinoma which has relapsed after surgery or for which there is no surgical indication, who have not been cured with or refused to receive other standard regimens, single or multiple doses of CAR-CLD18 T cells will be given to observe safety and efficacy of CAR-CLD18 T cells.
Determine the safety, tolerability and cytokinetics of the autologous T cells transduced with anti-Claudin18.2 lentiviral vector in patients with gastric adenocarcinoma and pancreatic adenocarcinoma.
Make a preliminary evaluation on the efficacy of CAR-CLD18 T cells in patients with gastric adenocarcinoma and pancreatic adenocarcinoma with the following parameters:
Time of tumor progression (TTP);
Disease Control Rate (DCR);
Objective Remission Rate (ORR);
Overall Survival (OS).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Redirected Autologous T Cells With a Claudin18.2-targeted Chimeric Antigen Receptor in Patients With Advanced Gastric Adenocarcinoma and Pancreatic Adenocarcinoma|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: CAR-CLD18 T cells
Autologous T Cells with a Claudin18.2-redirected Chimeric Antigen Receptor. Route of administration: Intravenous injection.
Lymphodepletion conditioning regimen will be applied prior to CAR-CLD18 T cell infusion.
Genetic: CAR-CLD18 T Cells
Dose escalation will be applied in this study.
Other Name: Claudin18.2-redirected Autologous Cells
- Safety and tolerance [ Time Frame: 24 weeks ]
During the trial conduction, especially within the 24 weeks of treatment phase when CAR-CLD18 T cell administered, all adverse events (including laboratory abnormality and clinical events) will be closely monitored, and all ≥ grade 3 adverse events per CTCAE (v 3.0) will be recorded, including but not limited to the toxicities potentially suspected to relate to infusion procedures and/or CAR-CLD18 T cell therapy as listed below:
- Nausea, vomiting and other gastrointestinal symptoms
- Respiratory distress
- Tumor lysis syndrome
- Cytokine release syndrome
- Neutropenia, thrombocytopenia
- Liver and kidney dysfunction
- Engraftment [ Time Frame: 2 years ]Duration of in vivo survival of CAR-CLD18 T cells is defined as "engraftment". The primary engraftment endpoint is the number of DNA vector copies per mL blood of CAR-CLD18 T cells at regular intervals through week 4 following the initial infusion. Q-PCR for CAR-CLD18 T vector sequences will be performed until any 2 sequential tests are negative, documented as engraftment and persistence of CAR-CLD18 T cells.
- Anti-tumor responses to CAR-CLD18 T cell infusions [ Time Frame: 2 years ]Disease Control Rate (DCR)
- Anti-tumor responses to CAR-CLD18 T cell infusions [ Time Frame: 2 years ]Progression-free Survival (PFS)
- Anti-tumor responses to CAR-CLD18 T cell infusions [ Time Frame: 2 years ]Time of Tumor Progression (TTP)
- Anti-tumor responses to CAR-CLD18 T cell infusions [ Time Frame: 2 years ]Overall Survival (OS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159819
|Contact: Xianbao Zhan, M.D.||email@example.com|
|Shanghai, Shanghai, China, 200433|
|Contact: Bin Wang, Dr. 86-021-31161448 firstname.lastname@example.org|
|Principal Investigator: Xianbao Zhan, M.D.|
|Sub-Investigator: Bin Wang, M.D.|
|Principal Investigator:||Xianbao Zhan, M.D.||Changhai Hospital|