Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03638193|
Recruitment Status : Unknown
Verified February 2021 by Shenzhen BinDeBio Ltd..
Recruitment status was: Recruiting
First Posted : August 20, 2018
Last Update Posted : February 4, 2021
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|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.
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Signed informed consent
- Unresectable or metastatic pancreatic cancer
- Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease
- 18 - 70 years of age
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months
- Satisfactory organ and bone marrow function
- Meets blood coagulation parameters
- Male and Female subjects of reproductive potential agree to use approved contraceptive methods
- Participation in a therapeutic investigational study within 4 weeks prior to the screening visit
- Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion
- Active invasive cancer other than pancreatic cancer
- HIV, HCV, or HBV infections
- Active autoimmune disease requiring immunosuppressive therapy within 4 weeks prior to screening visit, with exception of thyroid replacement
- Ongoing or active infection
- Planned concurrent treatment with systemic high dose corticosteroids
- Patients requiring supplemental oxygen therapy
- Prior therapy with gene modified cells
- Previous experimental therapy with SS1 moiety, murine or chimeric antibodies
- History of allergy to murine proteins
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
- Clinically significant pericardial effusion, CHF, or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study
- Pregnant or breastfeeding women
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)email@example.com|
|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|
|Responsible Party:||Shenzhen BinDeBio Ltd.|
|Other Study ID Numbers:||
|First Posted:||August 20, 2018 Key Record Dates|
|Last Update Posted:||February 4, 2021|
|Last Verified:||February 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Neoplasms
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Endocrine System Diseases