KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer

1. Inclusion Criteria: Subjects must meet all the following criteria to participate inthis study.

2. Signed, written informed consent obtained prior to any study procedures.

3. Age > 18 years at the time of informed consent.

4. Metastatic solid tumor with ≥ 10% of tumor cells positive for KK-LC-1 by IHC assay.Due to the low frequency of KK-LC-1 expression in most cancers, screening will focuson gastric, NSCLC, TNBC, and cervix cancers. The IHC test will be performed by theRutgers Cancer Institute, Department of Biorepository Services.

5. HLA-A*01:01 allele by HLA haplotype test.

6. Measurable disease per RECIST Criteria Version 1.1 at time of enrollment.

7. Prior treatment with cancer type-specific standard of care systemic cancer therapyis required. Standard treatment options must be considered and declined.Documentation of rationale is required if a subject is deemed unsuitable forstandard therapy.

8. Subjects with < 3 brain metastases that have been treated with surgery orstereotactic radiosurgery are eligible. Lesions that have been treated withstereotactic radiosurgery must be clinically stable for one month before protocoltreatment. Patients with surgically resected brain metastases are eligible.

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.

10. Negative pregnancy test for women under 55 and all women who have had a menstrualperiod in the last 12 months. A pregnancy tests is not required for women who havehad a bilateral oophorectomy or hysterectomy.

11. Women of child-bearing potential must agree to use adequate contraception (i.e.,intrauterine device, hormonal barrier method of birth control; abstinence; tuballigation or vasectomy) prior to study entry and for 12 months after treatment.Should a women become pregnant or suspect she is pregnant while she is participatingin this study, she should inform her treating physician immediately.

12. Participants must have organ and marrow function as defined below:

13. Leukocytes > 3,000/mcL

14. Absolute neutrophil count > 1,500/mcL

15. Platelets > 100,000/mcL

16. Hemoglobin > 9.0 g/dL

17. Total bilirubin within normal institutional limits except in participants withGilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL.

18. Serum AST (SGOT)/ALT (SGPT) < 2.5 x ULN

19. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2for participants withcreatinine levels above institutional normal (by the Chronic Kidney DiseaseEpidemiology Collaboration (CKD-EPI) equation).

20. INR or a PTT ≤1.5 X ULN unless the subject is receiving anticoagulant therapy.Subjects on anticoagulant therapy must have a PT or PTT within therapeuticrange and no history of severe hemorrhage.

21. Serology:

• HIV antibody negative

• Hepatitis B antigen negative

• Hepatitis C antibody negative or HCV RNC negative (i.e., no current HCVinfection)

13. More than four weeks must have elapsed since any prior systemic therapy at the timethe patient receives the KK-LC-1 TCR T cells. Adverse events from prior therapy musthave resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstratedclinical stability and meet the eligibility criteria for the protocol.

14. Oxygen saturation ≥ 92% on room air.

15. Left ventricular ejection fraction ≥45% by echocardiogram or MUGA for patients 50years of age or older.

Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:

1. Current treatment with another investigational agent.

2. History of severe allergic reactions to compounds of similar chemical or biologiccomposition to agents in used in study.

3. Uncontrolled intercurrent illness such as active infection, symptomatic congestiveheart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatricillness/social situations at the time of treatment that would limit compliance withstudy requirements.

4. Because there is an unknown but potential risk for adverse events in nursing infantssecondary to treatment of the mother with KK-LC-1 TCR T cells, breastfeeding shouldbe discontinued if the mother is treated with KK-LC-1 TCR cells. The potential risksmay also apply to other agents used in this study.

5. Participants with a systemic immunodeficiency including acquired deficiency such asHIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease areineligible. The experimental treatment being evaluated in this protocol depends onan intact immune system. Participants who have decreased immune competence may beless responsive to the treatment.

6. Participants on immunosuppressive drugs including corticosteroids unless meetingcriteria outlined in Section 6.1 (Prohibited Medications).

7. Subjects with HLA-A*01:01 damaging mutation or allele loss or other molecularresistance detected by clinical or research genomic profiling will not be eligible.

8. Participants with potentially severe autoimmune diseases such as Crohn's disease,ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmunepancreatitis, or systemic lupus erythematosus are not eligible. Patients with lesssevere autoimmune diseases such as hypothyroidism, vitiligo, and other minorautoimmune disorders are eligible.

9. Participants with prior or concurrent malignancy whose natural history or treatmentis unlikely to interfere with the safety or efficacy assessments of theinvestigational regimen are eligible for this trial. Examples include, but are notlimited to:

10. Carcinoma in situ

11. Cutaneous skin cancers requiring only local excision

12. Low grade non-muscle invasive bladder cancer

13. Low grade prostate cancer Participants with prior or concurrent malignancy thatdo not meet the above criteria are excluded.

14. Subjects who received a live vaccine within 30 days prior to enrollment are noteligible.

15. Determination by the Principal Investigator that participation is not in the bestinterest of the research subject or may jeopardize the safety of the subject orintegrity of the clinical trial data.