BridgeMD
New treatment option for Non-small Cell Lung Cancer
Official title A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
ClinicalTrials.gov ID: NCT05877599
What this study is testing
What is NT-175?
NT-175 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key (Module 1)
- people must be at least 18 years of age
- Subject must be diagnosed with one of the histologies below:
- NSCLC
- Colorectal adenocarcinoma
You likely can't join if
- (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.
See the full eligibility criteria
- Key (Module 1)
- people 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...
- 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
- (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 how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.