A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
AstraZeneca
Study ID
NCT05877599
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Autologous, engineered T Cells targeting TP53 R175H — BIOLOGICAL
    * Pre-conditioning by non-myeloablative chemotherapy with fludarabine and cyclophosphamide * Single infusion TCR T cells * Post-infusion recombinant interleukin-2 (rIL-2)

Study Details

Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors.

Key Dates

Start date
Jul 12, 2023
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation and Expansion
    Dose Escalation of TCR T cell product
  • Experimental: Part 1: Disease Histology Evaluation
    TCR T Cell Product at the MTD
  • Experimental: Part 2: Disease Cohort Expansion
    TCR T Cell Product at the RP2D

Primary Outcome Measure

Part 1: Safety of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: 28 days after infusion ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Research SiteGilbertArizona85234-
Research SiteDuarteCalifornia91010-
Research SiteNewport BeachCalifornia92663-
Research SiteSanta MonicaCalifornia90404-
Research SiteJacksonvilleFlorida32224-
Research SiteMiamiFlorida33136-
Research SiteTampaFlorida33612-
Research SiteBostonMassachusetts02115-
Research SiteNew BrunswickNew Jersey08901-
Research SiteNew YorkNew York10065-
Research SiteCharlotteNorth Carolina28204-
Research SiteWinston-SalemNorth Carolina27103-
Research SitePortlandOregon97213-
Research SitePittsburghPennsylvania15232-
Research SiteNashvilleTennessee37203-
Research SiteHoustonTexas77030-
Research SiteRound RockTexas78665-
Research SiteMilwaukeeWisconsin53226-

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