Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-28 @ 10:50 AM
Study NCT ID:
NCT05194735
Status:
TERMINATED
Last Update Posted:
2025-11-07
First Post:
2021-12-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors
Sponsor:
Alaunos Therapeutics
Organization:
Study Overview
Official Title:
Phase I/II Study of Autologous T Cells Engineered Using the Sleeping Beauty System to Express T-Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors
Status:
TERMINATED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors
Detailed Description:
A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors.
An HLA Typing and Tumor Neoantigen Mutation Testing Protocol (Protocol # TCR001-002) has been used to identify patients for potential enrollment into this Study Protocol. Subjects who have completed the HLA Typing and Tumor Neoantigen Mutation Testing Protocol, i.e., subjects for whom a TCR matching the subject's somatic mutation(s) and HLA type restriction combination is available in Alaunos' TCR library will be eligible for enrollment on this study.
The Phase I part of this study is a prospective, open-label, dose-escalation study of TCR-T cell drug product in patients with progressive or recurrent solid tumors who have failed standard therapy. The Phase II part is a prospective, open-label, single dose portion of the study. The Phase II part will begin once the MTD/RP2D in the Phase I part has been determined.
Subjects with one of the following histologically confirmed solid tumors will be included:
* Cohort 1: Gynecologic cancer (e.g., ovarian, endometrial)
* Cohort 2: Colorectal cancer
* Cohort 3: Pancreatic cancer
* Cohort 4: Non-small cell lung cancer (NSCLC); NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas
* Cohort 5: Cholangiocarcinoma
Subject must have a tumor mutation and HLA typing combination that matches to at least one of the following TCRs in the Alaunos' library (mutation \& HLA type):
* KRAS G12D \& HLA-A\*11:01
* KRAS G12D \& HLA-C\*08:02
* KRAS G12V \& HLA-A\*11:01
* KRAS G12V \& HLA-C\*01:02
* TP53 R175H \& HLA-A\*02:01
* TP53 R175H \& HLA-DRB1\*13:01
* TP53 R248W \& HLA-A\*68:01
* TP53 Y220C \& HLA-A\*02:01
* TP53 Y220C \& HLA-DRB3\*02:02
* EGFR E746-A750del \& HLA-DPA1\*02:01, DPB1\*01:01
An HLA Typing and Tumor Neoantigen Mutation Testing Protocol (Protocol # TCR001-002) has been used to identify patients for potential enrollment into this Study Protocol. Subjects who have completed the HLA Typing and Tumor Neoantigen Mutation Testing Protocol, i.e., subjects for whom a TCR matching the subject's somatic mutation(s) and HLA type restriction combination is available in Alaunos' TCR library will be eligible for enrollment on this study.
The Phase I part of this study is a prospective, open-label, dose-escalation study of TCR-T cell drug product in patients with progressive or recurrent solid tumors who have failed standard therapy. The Phase II part is a prospective, open-label, single dose portion of the study. The Phase II part will begin once the MTD/RP2D in the Phase I part has been determined.
Subjects with one of the following histologically confirmed solid tumors will be included:
* Cohort 1: Gynecologic cancer (e.g., ovarian, endometrial)
* Cohort 2: Colorectal cancer
* Cohort 3: Pancreatic cancer
* Cohort 4: Non-small cell lung cancer (NSCLC); NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas
* Cohort 5: Cholangiocarcinoma
Subject must have a tumor mutation and HLA typing combination that matches to at least one of the following TCRs in the Alaunos' library (mutation \& HLA type):
* KRAS G12D \& HLA-A\*11:01
* KRAS G12D \& HLA-C\*08:02
* KRAS G12V \& HLA-A\*11:01
* KRAS G12V \& HLA-C\*01:02
* TP53 R175H \& HLA-A\*02:01
* TP53 R175H \& HLA-DRB1\*13:01
* TP53 R248W \& HLA-A\*68:01
* TP53 Y220C \& HLA-A\*02:01
* TP53 Y220C \& HLA-DRB3\*02:02
* EGFR E746-A750del \& HLA-DPA1\*02:01, DPB1\*01:01
Study Oversight
Has Oversight DMC:
True
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?: