A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Cancers of the Stomach, Breast, Lung and Cervix.

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

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

3. Metastatic solid tumor with ≥ 25% 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 focus

on gastric, NSCLC, TNBC, and cervix cancers. The IHC test will be performed by the

Rutgers Cancer Institute of New Jersey, Department of Biorepository Services.

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

5. Measureable disease per RECIST Criteria Version 1.1 at time of enrollment.

6. Prior treatment with cancer type-specific stand of care systemic cancer therapy is

required. Standard treatment options must be considered and declined. Documentation of

rationale is required if a subject is deemed unsuitable for standard therapy.

7. Subjects with < 3 brain metastases that have been treated with surgery or stereotactic

radiosurgery are eligible. Lesions that have been treated with stereotactic

radiosurgery must be clinically stable for one month before protocol treatment.

Patients with surgically resected brain metastases are eligible.

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

9. Negative pregnancy test for women under 55 and all women who have had a menstrual

period in the last 12 months. A pregnancy tests is not required for women who have had

a bilateral oophorectomy or hysterectomy.

10. Women of child-bearing potential must agree to use adequate contraception (i.e.,

intrauterine device, hormonal barrier method of birth control; abstinence; tubal

ligation or vasectomy) prior to study entry and for four months after treatment.

Should a women become pregnant or suspect she is pregnant while she is participating

in this study, she should inform her treating physician immediately.

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

1. Leukocytes > 3,000/mcL

2. Absolute neutrophil count > 1,500/mcL

3. Platelets > 100,000/mcL

4. Hemoglobin > 9.0 g/dL

5. Total bilirubin within normal institutional limits except in participants with

Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL.

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

7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2for participants with

creatinine levels above institutional normal (by the Chronic Kidney Disease

Epidemiology Collaboration (CKD-EPI) equation).

8. 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 therapeutic range

and no history of severe hemorrhage.

12. Serology:

- HIV antibody negative

- Hepatitis B antigen negative

- Hepatitis C antibody negative or HCV RNC negative (i.e., no current HCV

infection)

13. More than four weeks must have elapsed since any prior systemic therapy or

radiotherapy at the time the patient receives the KK-LC-1 TCR T cells. Adverse events

from prior therapy must have resolved to≤ grade 1 according to CTCAE Version 5 or have

demonstrated clinical 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 50

years of age or older.