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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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 (NCT07072234) is a Phase 1 interventional studying Clear Cell Carcinoma and Phase 1, sponsored by M.d. Anderson Cancer Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Testing an investigational cancer therapy called TGFBR-2 KO CD70 CAR NK cell therapy.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Clear Cell Carcinoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Eligibility Criteria - Participants must have diagnosed by tissue sample (biopsy-confirmed) ccRCC that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. - Confirmation of CD70 expression ≥ 10% by immunohistochemistry staining of the participants primary renal tumor or a metastatic lesion biopsy specimen will be required for enrollment in the study. - Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. - Participants must have previously received treatment with at least one ICI and one TKI. Participants must have had unequivocal disease progression on ICI treatment. - Age ≥18 years. Because no dosing or adverse event data are currently available on the use of CD70 TGFβR-2 knockout CAR NK cells in Participants \<18 years of age, children are excluded from this study. - Participants must be at least 2 weeks from last cytotoxic chemotherapy, tyrosine kinas inhibitors or other targeted therapies at the time of administration of lymphodepleting chemotherapy. - Participants must be at least 3 months from any cell therapy for malignancy. - Localized radiotherapy to 1 or more disease sites is allowed prior to the lymphodepleting chemotherapy, provided that there are additional measurable non-irradiated disease sites. - Eastern Cooperative Oncology Group performance status 0 or 1 (Performance level as measured by Karnofsky for Participants \> 16 years of age. - your organs (liver, kidneys, etc.) are working well enough based on blood tests at screening, as defined by the following: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Eligibility Criteria * Participants must have histologically confirmed ccRCC that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * Confirmation of CD70 expression ≥ 10% by immunohistochemistry staining of the participants primary renal tumor or a metastatic lesion biopsy specimen will be required for enrollment in the study. * Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. * Participants must have previously received treatment with at least one ICI and one TKI. Participants must have had unequivocal disease progression on ICI treatment. * Age ≥18 years. Because no dosing or adverse event data are currently available on the use of CD70 TGFβR-2 knockout CAR NK cells in Participants \<18 years of age, children are excluded from this study. * Participants must be at least 2 weeks from last cytotoxic chemotherapy, tyrosine kinas inhibitors or other targeted therapies at the time of administration of lymphodepleting chemotherapy. * Participants must be at least 3 months from any cell therapy for malignancy. * Localized radiotherapy to 1 or more disease sites is allowed prior to the lymphodepleting chemotherapy, provided that there are additional measurable non-irradiated disease sites. * Eastern Cooperative Oncology Group performance status 0 or 1 (Performance level as measured by Karnofsky for Participants \> 16 years of age. * Adequate organ function at screening, as defined by the following: * Renal: Serum creatinine ≤ 1.5 mg/dL or estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration equation) ≥30 ml/min/1.73 m2o Hepatic: alanine transaminase (ALT)/aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if documented liver metastases, total bilirubin ≤ 1.5 mg/dL or ≤ 3.0 mg/dL for Participants with Gilbert's Syndrome. No history of liver cirrhosis. * Cardiac: Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion as determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no symptomatic cardiac disease or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication) * Pulmonary: No clinically significant pleural effusion (per principal investigator \[PI\] judgement), and baseline oxygen saturation ≥ 92% on room air. Subjects with active interstitial lung disease (ILD)/pneumonitis requiring treatment with systemic steroids will be excluded. * Hematological: absolute neutrophil count (ANC) ≥ 1000/mm3, platelet count ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL. o Coagulation: International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN. Participants on therapeutic doses of anticoagulation medication must have INR and/or aPTT ≤ the upper limit of the therapeutic range for intended use. * Able to provide written informed consent. * Aged ≥18 years. * Weight ≥40 kg. * All male and female Participants who are able to have children must practice effective birth control while on study therapy and for up to 3 months post completion of study therapy. Acceptable forms of birth control for female Participants include: hormonal contraception (implant, injectable contraceptive, transdermal patch, vaginal ring), intrauterine device, tubal ligation or hysterectomy, subject/partner post vasectomy, diaphragm with spermicide, condom with spermicide, or abstinence. Female Participants who become pregnant or suspect pregnancy must immediately notify their doctor. Female Participants who become pregnant will be taken off study. Men who are able to have children must use effective birth control while on the study therapy. Acceptable forms of birth control for male Participants include: vasectomy, condom with spermicide or abstinence. If the male Participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor. * Negative serum or urine beta human chorionic gonadotropin pregnancy test for females of childbearing potential (defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females) at screening. * Signed consent to long-term follow-up on protocol PA17-0483 and lab protocols PA17-0577 and LAB02-152. Exclusion Criteria * 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. * Documentation, during the screening process, of a QTc \> 470 milliseconds by Fredericia criteria (QTcF) based on the average of 3 electrocardiograms (ECGs) taken approximately 1 minute apart and all within 10 minutes of each other. The patient should be reclining for 5 minutes prior to ECGs. Local readings may be used for this exclusion criterion. * 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.

Treatments Being Tested

DRUG

Lymphodepleting chemotherapy

Given by IV

DRUG

Dexamethasone

Given PO

DRUG

Fludarabine

Given by IV

DRUG

Cyclophosphamate

Given by IV

DRUG

TGFBR-2 KO CD70 CAR NK

Given by IV

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

MD Anderson Cancer Center
Houston, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07072234), the sponsor (M.d. Anderson Cancer Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07072234 clinical trial studying?

Testing an investigational cancer therapy called TGFBR-2 KO CD70 CAR NK cell therapy. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07072234?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07072234?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07072234. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07072234. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.