Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05948033
Status:
RECRUITING
Last Update Posted:
2023-07-17
First Post:
2023-07-09
Brief Title:
CD70 Targeted CAR-T Cells in CD70 Positive RelapsedRefractory Lymphoma
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 RelapsedRefractory Lymphoma
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 RelapsedRefractory Lymphoma 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:
CAR-T cell therapy has been identified as a breakthrough therapy in hematologic malignanciesespecially anti-CD19 CAR-T cell therapy in the treatment of rr B-NHL has achieved remarkable efficacyHowever relapse with CD19-negative tumor after treatment with anti-CD19 CAR-T cells has been reported in different types of B-cell lymphoid malignancies with a percentage up to 38 in patients with non-Hodgkin lymphoma NHLAt present the CAR-T cell treatment for HL is mainly confined to CD30 antigenwith an objective response rate ORR only 3862 Therefore a more effective treatment strategy is needed for these patients
CD70 the membrane-binding ligand of the CD27 a tumor necrosis factor receptor superfamily has been reported to mediate tumour cell proliferation and be expressed on the malignant cells of diffuse large B-cell lymphoma DLBCLmantle cell lymphoma MCL and follicular lymphomas FL as well as Hodgkin lymphoma etcbut rarely on normal B cells or T cellsindicating CD70 targeted treament has emerged as potentialnovel immunotherapeutic strategyPreclinical study demonstrated CD70-CAR-T cells represent a new therapeutic option for the treatment of patients with CD19-negative recurrence of lymphomaBased 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 toxicitiesDLT pharmacokineticspharmacodynamics efficacy and other parameters to furtherly evaluate the safety and efficacy profiles of CD70-CAR-T cell therapy
CD70 the membrane-binding ligand of the CD27 a tumor necrosis factor receptor superfamily has been reported to mediate tumour cell proliferation and be expressed on the malignant cells of diffuse large B-cell lymphoma DLBCLmantle cell lymphoma MCL and follicular lymphomas FL as well as Hodgkin lymphoma etcbut rarely on normal B cells or T cellsindicating CD70 targeted treament has emerged as potentialnovel immunotherapeutic strategyPreclinical study demonstrated CD70-CAR-T cells represent a new therapeutic option for the treatment of patients with CD19-negative recurrence of lymphomaBased 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 toxicitiesDLT 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