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To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed PTCL.
In this study, anti CD7 CAR-T cell therapy will be explored for patients with relapsed/refractory PTCL. In this study, the 3+3 dose climbing mode will be used to explore the safety and efficacy of CAR-T cells in r/r PTCL therapy at different doses. The RP2D dose will be determined after the relevant data is summarized。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti CD7 CAR-T cells | Experimental | eligible patients will be treated with CD7-targeted CAR-T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T | Drug | autologous CD7-targeted CAR-T cells, single injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety: Dose-limiting toxicity | Observe the incidence rate of DLT events within 28 days after cell infusion | at least 28 days after the CAR-T cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the anti CD7 CAR-T cells to R/R PTCL | Remission rate, remission rate includes complete remission(CR)、partial remission(PR) | at least 1 year after the CAR-T cells infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Mo, phd | Contact | 8610-88326002 | mxd453@163.com | |
| Na Kuang | Contact | 86-18630160116 | kuangna@senlangbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | China |
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3+3 dose escalation design
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