Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05759728
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2023-02-13
Brief Title:
A Study of CNA3103 LGR5-targeted Autologous CAR-T Cells Administered to Subjects With Metastatic Colorectal Cancer
Sponsor:
Carina Biotech Limited
Organization:
Carina Biotech Limited
Study Overview
Official Title:
A Phase 12a Multicenter Open-Label Dose Escalation and Expansion Study of CNA3103 LGR5-targeted Autologous CAR-T Cells Administered to Adult Subjects With Metastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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 study aims to determine the safety and best response of treatment with CNA3103 Leucine-rich repeat-containing G protein-coupled receptor 5 LGR5-targeted Autologous Chimeric Antigen Receptor CAR -T Cells for participants with Metastatic Colorectal Cancer
Participants may undergo a pre-screening biopsy procedure to determine expression of LGR5
Participants will undergo screening procedures including leukapheresis collection of T cells and lymphodepletion chemotherapy up to 47 days prior to CNA3103 dosing
Participants will receive a single Intravenous dose of CNA3103
Expansion cohorts will open after determination of the maximum tolerated dose and recommended phase 2 dose in the dose escalation stage
Participants will be followed up monitored and will attend study visits for safety and research related tests and procedures for 2 years until disease progression unacceptable toxicity or intolerable adverse events death or withdrawal of consent
Participants may undergo a pre-screening biopsy procedure to determine expression of LGR5
Participants will undergo screening procedures including leukapheresis collection of T cells and lymphodepletion chemotherapy up to 47 days prior to CNA3103 dosing
Participants will receive a single Intravenous dose of CNA3103
Expansion cohorts will open after determination of the maximum tolerated dose and recommended phase 2 dose in the dose escalation stage
Participants will be followed up monitored and will attend study visits for safety and research related tests and procedures for 2 years until disease progression unacceptable toxicity or intolerable adverse events death or withdrawal of consent
Detailed Description:
This is a Phase 12a multicenter open-label study in adult subjects with metastatic colorectal cancer CRC The study will consist of 2 segments
Phase 1 Segment Dose Escalation a Bayesian Optimal Interval BOIN study design will be used to minimize any risks of exposure to the novel CNA3103 CAR-T cells during dose escalation while determining the Maximum Tolerated Dose MTD and Recommended Phase 2 Dose RP2D A minimum of 3 subjects per cohort will be enrolled at each dose level with appropriate staggering of subjects within and between dose levels
Phase 2a Segment Dose Expansion After determination of the MTDRP2D additional subjects will be enrolled and treated with CNA3103 at that dose to further assess the safety PK pharmacodynamic and anti-tumor properties of CNA3103 Based upon safety data of these additional subjects the Sponsor in consult with the Investigators may choose to enroll additional subjects at the same or a different dose
Phase 1 Segment Dose Escalation a Bayesian Optimal Interval BOIN study design will be used to minimize any risks of exposure to the novel CNA3103 CAR-T cells during dose escalation while determining the Maximum Tolerated Dose MTD and Recommended Phase 2 Dose RP2D A minimum of 3 subjects per cohort will be enrolled at each dose level with appropriate staggering of subjects within and between dose levels
Phase 2a Segment Dose Expansion After determination of the MTDRP2D additional subjects will be enrolled and treated with CNA3103 at that dose to further assess the safety PK pharmacodynamic and anti-tumor properties of CNA3103 Based upon safety data of these additional subjects the Sponsor in consult with the Investigators may choose to enroll additional subjects at the same or a different dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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