Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05947487
Status:
RECRUITING
Last Update Posted:
2023-07-17
First Post:
2023-07-08
Brief Title:
CD70 Targeted CAR-T Cells in CD70 Positive AdvancedMetastatic Solid Tumors
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Phase III Study of CD70 Targeted CAR-T Cell Treatment in CD70 Positive AdvancedMetastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this single-center single-armprospective open-label phase 12 study the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T CAR-T cell therapy will be evaluated in patients with CD70 antigen positive advancedmetastatic solid tumors In this clinical trial at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the 33 principle In dose expansion period additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 doseRP2D
Detailed Description:
Currently CAR-T cell therapy has already achieved tremendous success in the treatment of hematological malignancieshowever it remains a severe challenge to treat solid tumors due to multiple obstaclessuch as absence of tumor specific antigens complex immunosuppressive tumor microenvironment and tumor heterogeneity
CD70 is a member of the tumor factor superfamily and has been found to be highly expressed on the surface of several solid and hematological tumors correlating with inferior prognosisTargeting CD70 has emerged as potential novel immunotherapeutic strategy Investigators have developed CD70-CAR-T cells that could effectively expand and surviveproducing strong anti-tumor effects in animal models Based on the preclinical data we conduct this clinical trial in order to test the the safety profiles and anti-tumor activities of CD70-CAR-T cells in vivo In dose escalation period at least 12 eligible patients will be enrolled and receive 3 doses of CD70-CAR-T cell therapy 1 106 cellskg 3 106 cellskg 1 107 cellskg according to the 33 principle In dose expansion period additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell infusion at dose of RP2D which is determined by data from dose escalation period including occurrence of dose limiting toxicities DLT pharmacokineticspharmacodynamics efficacy and other parameters to furtherly evaluate the safety and efficacy profiles of CD70-CAR-T cell therapy
CD70 is a member of the tumor factor superfamily and has been found to be highly expressed on the surface of several solid and hematological tumors correlating with inferior prognosisTargeting CD70 has emerged as potential novel immunotherapeutic strategy Investigators have developed CD70-CAR-T cells that could effectively expand and surviveproducing strong anti-tumor effects in animal models Based on the preclinical data we conduct this clinical trial in order to test the the safety profiles and anti-tumor activities of CD70-CAR-T cells in vivo In dose escalation period at least 12 eligible patients will be enrolled and receive 3 doses of CD70-CAR-T cell therapy 1 106 cellskg 3 106 cellskg 1 107 cellskg according to the 33 principle In dose expansion period additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell infusion at dose of RP2D which is determined by data from dose escalation period including occurrence of dose limiting toxicities DLT pharmacokineticspharmacodynamics efficacy and other parameters to furtherly evaluate the safety and efficacy profiles of CD70-CAR-T cell therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None