Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03638193|
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : February 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Biological: CART-meso cells||Not Applicable|
This study is being conducted to assess the safety and efficacy of immunotherapy with CART-meso cells in dose escalation design. The trial will begin in Cohort 1 and progress to Cohorts 2, depending upon dose limiting toxicity (DLT) assessment .
Subjects will be enrolled serially, but infusions will be staggered to allow assessment of DLTs for determination of cohort progression, expansion, or dose de-escalation.
Cohort 1 subjects will receive a single dose of 1-3x10^7 /m^2 lentiviral transduced CART-meso cells after conditioning chemotherapeutic regimen.
Cohort 2 subjects will receive a single dose of 1-3x10^8 /m^2 lentiviral transduced CART-meso cells cells after conditioning chemotherapeutic regimen.
Dose limiting toxicity is defined as any adverse reactions at level 3 or above that may be associated with CART-meso within 4 weeks after infusion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Autologous T-cells Redirected to Mesothelin With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer|
|Actual Study Start Date :||July 11, 2018|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2022|
Experimental: CART-meso cells
A single dose of CART-meso T cells will be administered intravenously.The dose is 1-3×10^7/m^2 CART positive cells(chort 1)or 1-3×10^8/m^2 CART positive cells(chort 2).
Biological: CART-meso cells
CART-meso is a 2nd CAR, with mesothelin as target protein, 4-1BB as co- stimulator. The infusion will be scheduled to occur 3 (±1) days after a single dose of 1.5 grams/m^2 of cyclophosphamide, which will be administered according to standard procedures, Thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects.
- Safety of CART-meso infusion: number of adverse events [ Time Frame: 60 months ]Number of Adverse Events evaluated with NCI CTC AE, version 4.0[Safety evaluation]
- Clinical response of CART-meso [ Time Frame: 60 months ]Number of patients with tumor response including overal remission ,complete ression,progression-free survival，progressive disease ,etc.
- CAR-T cell detection [ Time Frame: 60 months ]Detection of transferred T cells in peripheral blood or bone marrow using multi-parameter flow cytometer.
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): NCT03638193
|Contact: Hongling ZHANG, PhD||(+86)firstname.lastname@example.org|
|Nanjing First Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210006|
|Contact: Jinfei CHEN, MD, PhD (+86)18951670922|
|Principal Investigator: Jinfei CHEN, MD, PhD|
|Principal Investigator:||Jinfei CHEN, MD, PhD||The First Affiliated Hospital with Nanjing Medical University|