TCR1188-ABC Cells in KRAS-mutated Cancers

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07594067
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TCR1188-ABC cells — BIOLOGICAL
    TCR1188 modified, base-edited autologous CD4+ and CD8+ T cells expressing TCR1188 and a scFv fragment specific to ILT4 (LILRB2) as a Single infusion on Day 0
  • Fludarabine + Cyclophosphamide combination — DRUG
    Fludarabine: 30 mg/m2/day x 4 days (Day -7 to -4) Cyclophosphamide: 600mg/m2/day x 3 days (Day -7 to -5)
  • Tocilizumab — DRUG
    Single administration of 8mg/kg on Day 2 (+3d)

Study Details

This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1188-ABC cells in patients with KRAS-mutated cancers. Initially, patients with KRAS G12V mutation positive metastatic pancreatic adenocarcinoma, cholangiocarcinoma, colorectal cancer, or non-small cell lung cancer (NSCLC) will be targeted for participation. Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jul 31, 2042
Completion
Jul 31, 2042

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level -1
    1.11 x 10\^8 TCR1188-ABC cells
  • Experimental: Dose level 1
    3.33 x 10\^8 TCR1188-ABC cells
  • Experimental: Dose level 2
    1 x 10\^9 TCR1188-ABC cells
  • Experimental: Dose level 3
    3 x 10\^9 TCR1188-ABC cells

Primary Outcome Measure

Number of Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V6.0 [ Time Frame: Up to 15 years following TCR1188-ABC cell administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Abramson Cancer Center Clinical Trials Service
[email protected]
215-349-8245

Find similar trials in Philadelphia, PA

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By specialty
OncologyGI oncologyLung oncologyLung disease
By research site
University of Pennsylvania· Philadelphia, PA

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