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Phase I Study of TGFBR-2 KO CD70 CAR NK Cells for Clear Cell Renal Cell Carcinoma

This study is testing an investigational cancer treatment called TGFBR-2 KO CD70 CAR NK cell therapy for people with clear cell renal cell carcinoma (ccRCC) that has spread or cannot be removed, and for which standard treatments are no longer working. Before receiving the main treatment, you would get chemotherapy (lymphodepleting chemotherapy, fludarabine, and cyclophosphamide) and dexamethasone. The main goal is to see how safe TGFBR-2 KO CD70 CAR NK cells are, what side effects they cause, and to find the best dose. Researchers will also look at whether the treatment helps shrink tumors or relieve symptoms. To join, your tumor must show a certain level of CD70 protein (10% or more) when tested.

Study design
This is an interventional study planning to enroll 30 participants. It is a Phase I study, which means it's an early-stage study focused on safety and dosing.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and any side effects will be monitored through study completion, which is an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07072234

Phase I Study of Allogeneic Transforming Growth Factor-beta Receptor Type 2 Knockout CD70 CAR NK Cells in Treatment Refractory Clear Cell Renal Cell Carcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~30 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:Lymphodepleting chemotherapyDexamethasoneFludarabineCyclophosphamateTGFBR-2 KO CD70 CAR NK

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Clear Cell Carcinoma
Phase 1
Growth Factor

Explore related trials

Clear Cell Renal Cell CarcinomaCD70 Antigen

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Andrew C Johns, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Andrew C Johns, MD
[email protected]
713-745-0138
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Exclusion

Presence of clinically significant ongoing Grade ≥ 2 toxicity unequivocally associated withthe previous anticancer treatment, as determined by the PI. Toxicities related to priorsurgery, radiation, prior systemic immune checkpoint inhibitors and chemotherapy should be resolved to Grade 1 or below prior to lymphodepletion.
Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management or not responding to appropriate therapy. Note: Participants with simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
Known active hepatitis B or C.
Known human immunodeficiency virus (HIV).
Presence of active neurological disorder(s).
Active autoimmune disease within 12 months of enrollment (excluding low-grade psoriasis or well-controlled autoimmune thyroid disease).
Amyloidosis or POEMS syndrome.
Symptomatic or uncontrolled central nervous system involvement or signs of cord compression. In the case radiation therapy is indicated, the washout must be at least 14 days.
Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, adequately treated (without recurrence post resection or post radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, or active non-life-threatening second malignancy that would not, in the investigator's opinion, potentially interfere with the Participant's ability to participate and/or complete this trial. Examples include but are not limited to urothelial cancer Grade Ta or T1 and adenocarcinoma of the prostate treated by active surveillance.
Presence of any other serious medical condition that may endanger the Participant at investigator's discretion, including but not limited to:
New York Heart Association Class III or IV heart failure
Myocardial infarction or stroke ≤ 26 weeks prior to CAR NK cell infusion
Unstable angina within ≤ 13 weeks prior to CAR NK cell infusion unless the underlying disease has been corrected by procedural intervention (e.g., stent, bypass)
Severe aortic stenosis
Uncontrolled arrhythmia. PI approval is required for Participants with arrhythmia who may be included as an exception.
Congenital long QT syndrome. PI approval is required.
Major surgery \< 4 weeks prior to first dose of lymphodepleting chemotherapy.
Concomitant use of other investigational agents.
Concomitant use of other anticancer agents.
Participants receiving systemic steroid therapy at time of enrollment, with an exception for topical, ocular, intranasal, and inhaled corticosteroids, or systemic corticosteroids at an equivalent dose ≤ 10 mg of prednisone daily (physiological substitutive doses are allowed).
Received antithymocyte globulin within 14 days or alemtuzumab within 28 days of enrollment.
Participants receiving immunosuppressive therapy.
Pregnant or breastfeeding.
Has received a live vaccine within 6 weeks prior to CAR NK cell infusion. Examples of live vaccines include but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza and COVID-19 vaccines for injection are generally killed virusvaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year

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