EpCAM CAR-T for Treatment of Nasopharyngeal Carcinoma and Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02915445|
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Nasopharynx TNM Staging Distant Metastasis (M) Breast Cancer Recurrent||Biological: CAR-T cells recognizing EpCAM||Phase 1|
In this study, the original tumor tissue specimen should be stained to determine the expression levels of EpCAM. Only the patients having tumor with high expression levels will be included.
50-100ml blood with be drawn to get enough CD3 T cells at least 2x10^7. After separation, PBMC will be activated via antibodies of CD3 and CD28 and then transduced by lentivirus bearing the EpCAM CAR gene. Then the EpCAM CAR-T cells will proliferate up to 10-100 folds for infusion. The produced cells will be frozen or infused if available.
Included patients will be preconditioned by cyclophosphamide for lymphodepletion if the levels of white blood cells and lymphocytes are normal. Infusion of T cells, at least 1 day after lymphodepletion, is dose escalating and beginning at the lowest level. If the first level is proven to be safe, the next level will be proceeded. Once severe side effects were observed, the dose will be lowered or the dose will be stopped.
During infusion, patients will be taken care of by cardiogram monitor. Blood drawing will be taken before infusion, at 4h after infusion and on day 4, 7, 14, 30, 60, 90, 120, 150, 180 to determine the presence of CAR-T cells. At the same time, cytokines including IL-6, TNF-alpha and IFN-gamma and C-reactive protein levels will be determined. Routine imaging studies will be proceeded.
To see whether there are long-term side effects of this therapy, patients received CAR-T cells will be followed up to at least 15 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||T Cells Armed With Chimeric Antigen Receptor Recognizing EpCAM for Patients With Nasopharyngeal Carcinoma and Breast Cancer|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2022|
Experimental: CAR-T cells recognizing EpCAM
Autologous T cells from patient are engineered to expressing a special chimeric antigen receptor to recognizing EpCAM by lentiviral vector. The engineered T cells were then endowed cytotoxicity to the tumor cells and hold the potential to inhibit the advance of tumors.
Biological: CAR-T cells recognizing EpCAM
Patients included will be infused the autologous T cells armed with CAR recognizing EpCAM. After infusion, cytokines and other medical test will be performed.
- Number of participants with treatment-related adverse events/dose limiting toxicity as assessed by CTCAE v4.0 [ Time Frame: 6 weeks after infusion ]Determine the largest dose of EpCAM CAR-T cells for patients with nasopharyngeal carcinoma and breast cancer expressing EpCAM.
- Response rate of participants treated with EpCAM CAR-T cells assessed by RECIST v1.1 [ Time Frame: 6-12 weeks after infusion of the CAR-T cells ]Determine whether there is therapeutic efficacies of the safe dose infusion of EpCAM CAR-T cells for patients with nasopharyngeal and breast cancer.
- Persistence of EpCAM CAR-T cells and correlation with the Response rate [ Time Frame: 6-12 weeks post CAR-T infusion ]
- Persistence of EpCAM positive circulating tumor cells [ Time Frame: 6 weeks post CAR-T infusion ]
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): NCT02915445
|Contact: Wei Wang, Ph.D||+86 028 email@example.com|
|West China Hospital, Sichuan University||Recruiting|
|Chengdu, Sichuan, China, 610041|
|Contact: Nianyong Chen, MD +86 028 85422952 firstname.lastname@example.org|
|Principal Investigator: Nianyong Cheng, MD|
|Principal Investigator:||Wei Wang, Ph.D||State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University|