Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-04-29
30
Participants Needed
1
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Testing an investigational cancer therapy called TGFBR-2 KO CD70 CAR NK cell therapy.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed metastatic or unresectable clear cell renal cell carcinoma with no effective standard treatments
- Tumor must show CD70 expression of 10% or more by immunohistochemistry
- Participants must have measurable disease with lesions at least 20 mm by chest x-ray or 10 mm by CT, MRI, or clinical exam
- Prior treatment with at least one immune checkpoint inhibitor and one tyrosine kinase inhibitor, with disease progression on immune checkpoint inhibitor
- Age 18 years or older
- At least 2 weeks since last cytotoxic chemotherapy, tyrosine kinase inhibitors, or targeted therapies before lymphodepleting chemotherapy
- At least 3 months since any prior cell therapy for cancer
- Localized radiotherapy allowed if additional measurable non-irradiated disease sites exist
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate organ function including kidney, liver, heart, lung, and blood counts as defined in protocol
- Able to provide written informed consent
- Weight 40 kg or more
- Effective birth control use for participants able to have children during and up to 3 months after study therapy
- Negative pregnancy test for females of childbearing potential
- Signed consent for long-term follow-up and laboratory protocols
You will not qualify if you...
- Ongoing grade 2 or higher toxicities from prior anticancer treatments
- Infections needing intravenous antimicrobials or not responding to treatment (except simple urinary tract infection or uncomplicated bacterial pharyngitis responding to treatment)
- Known active hepatitis B or C infection
- Known HIV infection
- Active neurological disorders
- Autoimmune disease within 12 months (except mild psoriasis or controlled autoimmune thyroid disease)
- Amyloidosis or POEMS syndrome
- Symptomatic or uncontrolled central nervous system involvement or spinal cord compression
- Other cancers within 2 years except certain adequately treated or non-life-threatening malignancies
- Serious heart conditions including recent myocardial infarction, unstable angina, severe aortic stenosis, uncontrolled arrhythmias, or long QT syndrome
- Major surgery within 4 weeks prior to lymphodepleting chemotherapy
- Use of other investigational or anticancer agents
- Systemic steroid therapy at enrollment except low-dose or specific forms
- Recent use of antithymocyte globulin or alemtuzumab
- Immunosuppressive therapy
- Pregnant or breastfeeding
- Receipt of live vaccines within 6 weeks prior to CAR NK cell infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Andrew C Johns, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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