Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055439
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2023-09-13
Brief Title:
A Phase 12 Study to Evaluate CHM-2101 an Autologous Cadherin 17 Chimeric Antigen Receptor CAR T Cell Therapy
Sponsor:
Chimeric Therapeutics
Organization:
Chimeric Therapeutics
Study Overview
Official Title:
A Phase 12 Study to Evaluate CHM-2101 an Autologous Cadherin 17 CDH17 Chimeric Antigen Receptor CAR T Cell Therapy for the Treatment of Relapsed or Refractory Gastrointestinal Cancers
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:
The goal of this clinical trial is to evaluate CHM-2101 an autologous CDH17 CAR T-cell therapy for the treatment of advanced gastrointestinal GI cancers that are relapsed or refractory to at least 1 standard treatment regimen in the metastatic or locally advanced setting
Detailed Description:
This is a Phase 12 open-label study to evaluate CHM-2101 an autologous CDH17 CAR T-cell therapy for the treatment of advanced gastrointestinal GI cancers that are relapsed or refractory to at least 1 standard treatment regimen in the metastatic or locally advanced setting
The study has 2 parts Phase 1 Dose Escalation and Expansion and Phase 2 Potential participants will provide written consent and be screened for study eligibility prior to undergoing any screening procedures including leukapheresis Protocol-specified criteria must be met prior to the start of leukapheresis for collection of peripheral blood mononuclear cells PBMCs Eligible participants will undergo leukapheresis to collect PBMCs for product manufacturing which comprises enrichment of T cells lentiviral transduction ex vivo expansion and cryopreservation of the CHM-2101 cell product Participants who have a leukapheresis or manufacturing failure may be permitted a second attempt at leukapheresis
Bridging chemotherapy treatment between the time of leukapheresis and first dose of lymphodepleting chemotherapy LDC is permitted at the discretion of the investigator if needed to maintain disease stability during CHM-2101 manufacturing time Bridging chemotherapy is prohibited within the 2 weeks prior to leukapheresis and 2 weeks prior to planned CHM-2101 infusion Specific criteria to proceed should be reviewed prior to leukapheresis LDC and CHM-2101 infusion Participants will be followed in this study for 18 months or until disease progression
The study has 2 parts Phase 1 Dose Escalation and Expansion and Phase 2 Potential participants will provide written consent and be screened for study eligibility prior to undergoing any screening procedures including leukapheresis Protocol-specified criteria must be met prior to the start of leukapheresis for collection of peripheral blood mononuclear cells PBMCs Eligible participants will undergo leukapheresis to collect PBMCs for product manufacturing which comprises enrichment of T cells lentiviral transduction ex vivo expansion and cryopreservation of the CHM-2101 cell product Participants who have a leukapheresis or manufacturing failure may be permitted a second attempt at leukapheresis
Bridging chemotherapy treatment between the time of leukapheresis and first dose of lymphodepleting chemotherapy LDC is permitted at the discretion of the investigator if needed to maintain disease stability during CHM-2101 manufacturing time Bridging chemotherapy is prohibited within the 2 weeks prior to leukapheresis and 2 weeks prior to planned CHM-2101 infusion Specific criteria to proceed should be reviewed prior to leukapheresis LDC and CHM-2101 infusion Participants will be followed in this study for 18 months or until disease progression
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