Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383507
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-22
Brief Title:
A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive Refractory or Relapsed Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
This is a single-center single-arm open-label dose escalation and dose extension study In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors and obtain recommended doses and infusion patterns
Detailed Description:
In the discovery phase accelerated titration combined with the 33 dose escalation principle was adopted starting from the initial dose of 3106kg If a grade 3 AE occurs during DLT observation the accelerated titration mode will switch to 33 dose escalation at least 12 eligible patients will be enrolled and receive 4 doses of CD70 UCAR-T cell therapy 3 106 cellskg 6 106 cellskg 8 106 cellskg 1 107 cellskg
In the dose expansion phase each group will choose one or two dose groups to verify the safety and efficacy and plan to recruit about 6 subjects in each dose group
During the clinical study after the completion of each dose group the Safety Monitoring Committee SMC will determine whether it is possible to continue to increase to the next higher dose group or add more subjects to the current dose group or reduce to a lower dose group to continue to explore or climb to a higher dose after reaching the highest dose 1 107 cellskg
Conditions Relapsed Tumor Refractory Solid Tumor Renal Cell Carcinoma Head and Neck Squamous Cell Carcinoma Nasopharyngeal carcinoma Ovarian Cancer Cervix Cancer etal
In the dose expansion phase each group will choose one or two dose groups to verify the safety and efficacy and plan to recruit about 6 subjects in each dose group
During the clinical study after the completion of each dose group the Safety Monitoring Committee SMC will determine whether it is possible to continue to increase to the next higher dose group or add more subjects to the current dose group or reduce to a lower dose group to continue to explore or climb to a higher dose after reaching the highest dose 1 107 cellskg
Conditions Relapsed Tumor Refractory Solid Tumor Renal Cell Carcinoma Head and Neck Squamous Cell Carcinoma Nasopharyngeal carcinoma Ovarian Cancer Cervix Cancer etal
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