Phase 1 Study Of LNK001 In Advanced Or Metastatic Clear Cell Renal Cell Carcinoma

NCT07564232 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2026-0179NCI-2026-03335
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There are 2 parts to this clinical research study: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The goal of Part 1 is to find the recommended dose of LNK001 in patients with advanced or metastatic ccRCC. The goal of Part 2 is to learn if the recommended dose of LNK001 found in Part 1 can help to control the disease.

Conditions

Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Part 1/2: ESC/EXP treatment with CAR-T LNK001

EXPERIMENTAL

Drug: Cyclophosphamide; Drug: Fludarabine; Drug: LNK001

Interventions

Cyclophosphamide DRUG

Given by IV

Also known as: Cytoxan

Part 1/2: ESC/EXP treatment with CAR-T LNK001

Fludarabine DRUG

Given by IV

Also known as: Fludara

Part 1/2: ESC/EXP treatment with CAR-T LNK001

LNK001 DRUG

Given by infusion

Part 1/2: ESC/EXP treatment with CAR-T LNK001

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed metastatic/advanced RCC with a clear cell component who have received at least one prior line of systemic treatment in the advanced or metastatic setting, including at least one PD-1/PD-L1 immune checkpoint inhibitor (ICI) and one tyrosine kinase inhibitor (TKI). Patients with locally advanced disease who are eligible for curative resection are excluded.
• For patients who received one prior line of therapy, they must have had evidence of disease progression. For patients who received 2 or more prior lines of therapy, evidence of progression is not required if they stopped treatment for intolerance.
• Confirmation of CAIX expression ≥ 50% at any intensity (greater than 0) by immunohistochemistry staining of the patient's primary renal tumor or a metastatic lesion biopsy specimen will be required for enrollment in the study. Both overall extent of expression and staining intensity will be scored. Archival tissues that exist prior to the time of enrollment will be used for this purpose.
• Patients must have at least one measurable site of disease per RECIST version 1.1.4.
• ECOG performance status ≤ 1.
• Age ≥ 18 years.
• Patients must have adequate organ and marrow function as defined below:
• 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
• 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.
• Left ventricular ejection fraction ≥ 45% by echocardiogram or MUGA scan.

You may not qualify if:

• Participants must not have any other malignancies requiring active treatment within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early-stage prostate adenocarcinoma with negligible risk of metastasis or death.
• Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after cell infusion (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.
• History of major cardiovascular diseases prior to enrollment: unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 6 months prior to consenting, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia, clinically significant pericardial effusions).
• Symptomatic CNS metastases, leptomeningeal disease, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrollment, or potential need for CNS radiation within the first 28 days from LNK001 therapy.
• Patients with treated/stable brain metastases are allowed on protocol if they had brain metastases that received CNS-directed therapy, such as surgery or treatment with radiosurgery or Gamma knife, without recurrence or edema for at least 1 month (4 weeks). Patients actively requiring glucocorticoids for uncontrolled brain or leptomeningeal metastases are not eligible. Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).
• Active autoimmune diseases requiring systemic therapy (e.g., with disease-modifying drugs, prednisone \>10 mg daily or equivalent, immunosuppressant therapy). However, the following will be allowed:
• 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.
• Ongoing treatment with systemic corticosteroid therapy at doses of prednisone \> 10 mg/day or equivalent.
• Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Prior ex vivo, in vivo, autologous or allogeneic CAR T therapy.
• Prior treatment with investigational therapeutics that target CAIX or ENPP3.
• Severe infection within 4 weeks prior to enrollment (e.g. patients requiring hospitalization, severe sepsis, or severe pneumonia with respiratory failure).
• Active ongoing infection requiring oral or IV antimicrobials prior to consenting.
• Preventive antimicrobials are permitted

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Cyclophosphamide; fludarabine; fludarabine phosphate

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Samer A Srour, MBBCH

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samer A Srour, MBBCH

CONTACT

(713) 794-4354; ssrour@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 6, 2031
• Study Completion (Estimated): June 6, 2033
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)