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A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation

NCT05877599

RecruitingPhase 1

Sponsor: AstraZeneca

Conditions: Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma, Breast Cancer

Interventions: NT-175

Countries: United States

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 malignancies

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria (Module 1)

* Subjects must be at least 18 years of age
* Subject must be diagnosed with one of the histologies below:

  * NSCLC
  * Colorectal adenocarcinoma
  * HNSCC
  * Pancreatic adenocarcinoma
  * Breast cancer
  * Ovarian cancer
  * Any other solid tumor
* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\*02:01 positive (at least 1 allele)
* Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.
* Subject has at least 1 measurable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Adequate hematological, renal, hepatic, pulmonary, and cardiac function

Key Exclusion Criteria (Module 1)

* Any another primary malignancy within the 3 years prior to enrollment
* Known, active primary central nervous system (CNS) malignancy
* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.
* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.
* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.
* Any form of primary immunodeficiency.
* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.

Key Inclusion Criteria (Module 2 - hematological malignancies)

* At least 18 years of age
* Diagnosis of AML or MDS that allows for efficacy assessments
* Confirmation of TP53 R175H variant mutation in cancer cells
* Subject must be HLA-A\*02:01 positive (at least 1 allele)
* ECOG performance status of 0 to 1

Key Exclusion Criteria (Module 2 - hematological malignancy)

* Acute promyelocytic leukaemia or isolated extramedullary disease
* Another primary malignancy within 2 years (with exceptions)
* HSCT within 100 days or immunosuppression for GvHD within 4 weeks
* History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells
* Prior stroke, ischemic attack, significant cardiac disease, heart failure
* Prior adoptive modified cell therapy
* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.

Locations (18)

Gilbert, Arizona, United States
Duarte, California, United States
Newport Beach, California, United States
Santa Monica, California, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Boston, Massachusetts, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Round Rock, Texas, United States
Milwaukee, Wisconsin, United States