Program Status
Active, not recruitingPhase
Phase 1Prior Immunotherapy Allowed
YesCRC-directed Trial
YesTags
MSI-H/ MMRd, MSS/ MMRpComments
Adoptive cells immunotherapy, targeted to KRAS G12D mutation.
Admits patients with Stage III or IV colon and/or rectal cancer, with KRAS G12D mutation and HLA-C*08:02 positive (both, MSS and MSI-H)
NT-112: Autologous, engineered T Cells targeting KRAS G12D
At least 1 line of prior treatment required, not prior adoptive cell and gene therapy allowed (not mention of prior checkpoint inhibitor being an exclusion criterion).
Patients receive a with fludarabine and cyclophosphamide, and late one unique infusion of T cell receptor (TCR) T cells. After that, other immunotherapy, recombinant interleukin-2 (rIL-2).
| Location | Location Status |
|---|---|
| United States | |
|
Research Site Duarte, California 91010 |
Active, not recruiting |
|
Research Site Los Angeles, California 90095 |
Active, not recruiting |
|
Research Site Newport Beach, California 92663 |
Active, not recruiting |
|
Research Site Westwood, Kansas 66205 |
Active, not recruiting |
|
Research Site Saint Louis, Missouri 63110 |
Active, not recruiting |
|
Research Site New York, New York 10016 |
Active, not recruiting |
|
Research Site Pittsburgh, Pennsylvania 15237 |
Active, not recruiting |
|
Research Site Nashville, Tennessee 37203 |
Active, not recruiting |
|
Research Site Dallas, Texas 75246 |
Active, not recruiting |
|
Research Site Galveston, Texas 77555 |
Active, not recruiting |
|
Research Site Houston, Texas 77030 |
Active, not recruiting |
|
Research Site Aberdeen, Washington 98520 |
Active, not recruiting |
|
Research Site Milwaukee, Wisconsin 53226 |
Active, not recruiting |
Inclusion Criteria
Key Inclusion Criteria:
* Age ≥18 years
* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor
* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C*08:02 positive
* 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.
* Presence of at least 1 measurable lesion per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment
Key
Exclusion Criteria
Exclusion Criteria:
* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer
* 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 stroke or transient ischemic attack within the 12 months prior to enrollment.
* 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.
* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)
* Female of childbearing potential who is lactating or breast feeding at the time of enrollment
