Inclusion
Hemoglobin ≥ 8 g/dl
Absolute neutrophil count ≥1,500/mcL
Platelets ≥100,000/mcL
Total bilirubin ≤ 1.5 mg/dL; for patients with liver metastases or confirmed/suspected Gilbert syndrome, TBIL ≤3 × ULN
AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN
Creatinine (CrCl) ≥ 30 mL/min using either the Cockcroft-Gault formula or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 7. INR and PT ≤ 1.5 x ULN and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). Therapeutic anticoagulation with low molecular weight heparin (LMWH) or direct oral anticoagulant (DOAC) is permitted if the participant is on a stable therapeutic dose for at least 2 weeks at the time of enrollment. 8. Left ventricular ejection fraction ≥ 45% by echocardiogram or MUGA scan. 9. For patients with a history of chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections, the HBV and HCV viral loads must be undetectable. 10. Patients with a history of major psychiatric illness must be judged (by the treating physician) able to fully understand the investigational nature of the study and the risks associated with the therapy. 11. The effects of LNK001 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
History of bilateral tubal ligation or another surgical sterilization procedure.
Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) before study entry. Pregnancy test must be repeated on the day of first infusion, if test performed \> 14 days before starting study drug.
Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the LNK001. Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of LNK001. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of LNK001.
Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring)
Intrauterine device (IUD)
Tubal Ligation or hysterectomy
Subject/Partner post vasectomy
Implantable or injectable contraceptives, and condoms plus spermicide
Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control 12. Ability to understand and the willingness to sign a written informed consent document for the clinical trial. 13. Willingness to enroll in a 15-year long term follow-up surveillance protocol post LNK001 dosing.
Exclusion
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.
Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections. 6. Ongoing treatment with systemic corticosteroid therapy at doses of prednisone \> 10 mg/day or equivalent. 7. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 8. Prior ex vivo, in vivo, autologous or allogeneic CAR T therapy. 9. Prior treatment with investigational therapeutics that target CAIX or ENPP3. 10. Severe infection within 4 weeks prior to enrollment (e.g. patients requiring hospitalization, severe sepsis, or severe pneumonia with respiratory failure).