TCR1020-CD8 T Cells in KRAS-mutated Cancers
NCT06707896 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2025-06-25
Summary
This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1020-CD8 T cells in patients with KRAS-mutated cancers. Initially, patients with KRAS G12V mutation positive metastatic pancreatic adenocarcinoma or colorectal cancer will be targeted for participation. Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.
Conditions
- Metastatic Pancreatic Adenocarcinoma
- Colorectal Cancer
Interventions
- DRUG
-
TCR1020-CD8 T cells
TCR1020-CD8 T cells are autologous mKRAS-redirected CD8+ T cells engineered using a lentiviral vector to express a TCR with specificity for HLA-restricted mKRAS G12V epitopes restricted to the HLA-A\*11:01 molecule.
Sponsors & Collaborators
-
Stand Up To Cancer
collaborator OTHER -
Lustgarten Foundation
collaborator OTHER - lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2029-02-01
- Completion
- 2044-02-01
- FDA Drug
- Yes
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