Phase
Condition
Neoplasms
Treatment
NW-301D
NW-301V
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Age between 18-75 years
Diagnosis of pathologically or histologically confirmed unresectable or advancedsolid tumor, and have no standard treatment options available or unable to toleratethe currently available standard treatments
HLA-A11:01positive Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort)mutation * Adequate organ function prior to apheresis and lymphodepletingchemotherapy
ECOG performance status of 0-1
At least one tumor lesion measurable according to RECIST 1.1 (Additionalprotocol-defined Inclusion criteria may apply.)
Exclusion
Key Exclusion Criteria:
Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior toapheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpointinhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurininhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil,rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, oranti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior tolymphodepletion
History of allergic reactions to cyclophosphamide, fludarabine, or any otherchemical or biological components of the drugs used in this study
History of chronic or recurrent severe autoimmune disease, or active immune diseaserequiring treatment with steroids or other immunosuppressive agents within 1 yearprior to enrollment* Have symptomic CNS metastases
Have leptomeningeal disease or carcinomatous meningitis
Have ongoing or active infection
Active infections with HIV, HBV, HCV, or syphilis
Breastfeeding or pregnant (Additional protocol-defined Exclusion criteria mayapply.)
Study Design
Study Description
Connect with a study center
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin
ChinaSite Not Available
Tianjin Medical University Cancer Institute and Hospital
Tianjin 1792947, Tianjin Municipality 1792943
ChinaActive - Recruiting

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