Treatment with engineered T cells for advanced solid tumors with a specific mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label, multicenter study evaluates the safety and preliminary antitumor activity of NT-175, an autologous T cell therapy targeting the TP53 R175H mutation in patients with unresectable, advanced, and/or metastatic solid tumors. Eligible participants must be HLA-A*02:01 positive and have specific cancer types, including non-small cell lung cancer and breast cancer, among others. The study will involve dose escalation to determine the maximum tolerated dose (MTD) and further assess the therapy's effectiveness in specific disease cohorts.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Gilbert, Arizona, United States Recruiting
• Research Site
  Duarte, California, United States Recruiting
• Research Site
  Los Angeles, California, United States Recruiting
• Research Site
  Newport Beach, California, United States Recruiting
• Research Site
  Santa Monica, California, United States Recruiting
• Research Site
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.