Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545201
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-30
Brief Title:
RE001 T Cell Injection for the Treatment of KRAS G12V Mutated Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RE001 T Cell Injection for the Treatment of KRAS G12V Mutated Solid Tumors an Open-label Single-center Phase I Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At present there is an urgent need for new drugs for kirsten rat sarcoma viral oncogene KRAS mutant tumors in clinic Preclinical studies support the specificity safety and anti-tumor activity of RE001 Previous similar studies suggest the feasibility of T cell receptor engineered T cell therapy TCR-T treatment and measures have been taken to ensure the safe administration of RE001 and the close monitoring and management of adverse events To sum up RE001 has controllable safety and anti-tumor activity on KRAS mutant solid tumor which can be preliminarily studied to provide support for clinical research of patients with advanced solid tumor
Detailed Description:
This study is a single-center open single-arm dose-increasing single-dose phase I clinical trial of safety and tolerance It is planned to recruit 30 patients with advanced malignant solid tumor with KRAS G12V mutation
In this experiment 33 dose increasing design was adopted and the dose increasing scheme was as follows deviation 30 low dose group 4109 middle dose group 8109 and high dose group 161010 At least 21 days before T cell infusion peripheral blood mononuclear cell PBMC about 1109 of the subjects were collected by a single blood cell separator After gene editing these cells were amplified in vitro and infused into the subjects after reaching the target number The evaluation period of dose-limited toxicity DLT was 28 days after the first administration of each dose group
The subjects were administered at intervals and the interval of administration began from the day of TCR-T cell infusion of the previous subject to the day of TCR-T cell infusion of the next subject The interval between the first three subjects in the same dose group and the next subject the same group or different groups is at least 14 days If one third of the subjects in the dose group have DLT and three new subjects need to be added the interval with the next subject same group or different group should be at least 21 days
All the subjects who met the entry and exit criteria and signed the informed consent form were observed in hospital at the beginning of lymphocyte clearance chemotherapy with the dosage of cyclophosphamide 600-800mgm2days-5-4 days and fludarabine 25-30mgm2days-5-4-3 days at least two days after the completion of lymphocyte clearance chemotherapy
During the trial the subjects can withdraw from the study at any time for any reason which will not affect the subsequent treatment and care of the subjects by medical staff or medical institutions
In this experiment 33 dose increasing design was adopted and the dose increasing scheme was as follows deviation 30 low dose group 4109 middle dose group 8109 and high dose group 161010 At least 21 days before T cell infusion peripheral blood mononuclear cell PBMC about 1109 of the subjects were collected by a single blood cell separator After gene editing these cells were amplified in vitro and infused into the subjects after reaching the target number The evaluation period of dose-limited toxicity DLT was 28 days after the first administration of each dose group
The subjects were administered at intervals and the interval of administration began from the day of TCR-T cell infusion of the previous subject to the day of TCR-T cell infusion of the next subject The interval between the first three subjects in the same dose group and the next subject the same group or different groups is at least 14 days If one third of the subjects in the dose group have DLT and three new subjects need to be added the interval with the next subject same group or different group should be at least 21 days
All the subjects who met the entry and exit criteria and signed the informed consent form were observed in hospital at the beginning of lymphocyte clearance chemotherapy with the dosage of cyclophosphamide 600-800mgm2days-5-4 days and fludarabine 25-30mgm2days-5-4-3 days at least two days after the completion of lymphocyte clearance chemotherapy
During the trial the subjects can withdraw from the study at any time for any reason which will not affect the subsequent treatment and care of the subjects by medical staff or medical institutions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None