Can a Patient's own immune cells beat advanced kidney cancer?
NCT ID NCT07770802
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This early-stage trial is testing an experimental therapy called HS-IT101 for people with advanced clear cell renal cell carcinoma, a type of kidney cancer. The treatment involves collecting immune cells from the patient's tumor, multiplying them in the lab, and infusing them back after a short course of chemotherapy to make room for them. The goal is to see if this personalized cell therapy is safe and can shrink or control the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HS-IT101, a personalized cell therapy made from a patient's own tumor-infiltrating lymphocytes (TILs), given after a short course of chemotherapy (cyclophosphamide and fludarabine) and followed by interleukin-2 (IL-2) injections.
- What this could lead to
- If successful, this could lead to a new treatment option that harnesses the immune system to fight advanced kidney cancer, potentially offering long-term remission.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. The treatment involves intensive chemotherapy and IL-2, which can cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 to 75 years; 2. Histologically or cytologically confirmed advanced clear cell renal cell carcinoma; 3. At least one measurable lesion per RECIST 1.1; 4. ECOG performance status of 0 or 1; 5. Life expectancy of at least 3 months; 6. Adequate hematologic, hepatic, and renal function; 7. Washout period of at least 4 weeks since prior anticancer therapy; 8. Recovery from prior treatment-related adverse events to ≤ Grade 1 or baseline; 9. Signed informed consent obtained before any study procedures。 Exclusion Criteria: 1. Use of any immunosuppressive medications, such as corticosteroids, within 4 weeks prior to tumor tissue collection, or presence of a concurrent disease requiring immunosuppressive medication during the study as judged by the investigator. Intranasal or topical corticosteroid use is allowed. 2. Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study, except cytoreductive surgery performed for tumor tissue collection. 3. Received systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to tumor tissue collection. 4. Received a live vaccine within 3 months prior to screening, or plans to receive a live vaccine during the study. 5. History of severe hypersensitivity reaction to any drug used in the study. 6. Prior treatment with similar cell therapy products. 7. Prior organ transplantation or hematopoietic stem cell transplantation. 8. Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation. 9. Any of the following events within 6 months prior to screening: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism. 10. Diagnosis of another primary malignancy within 5 years prior to screening, except curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ. 11. Pleural effusion, pericardial effusion, or ascites that remains uncontrolled despite drainage or requires repeated drainage. 12. Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of study treatment. 13Severe respiratory disease. 14.Known leptomeningeal metastasis; symptomatic central nervous system (CNS) metastases. Participants with previously treated brain metastases who are clinically stable (as confirmed by MRI) for at least 12 weeks may be enrolled. 15.Any uncontrolled clinical condition. 16.Active autoimmune disease requiring systemic treatment during the study. 17.Presence of acute or chronic infection. 18.Pregnant or breastfeeding women. 19.Known psychiatric illness, alcoholism, drug abuse, or substance abuse. 20.Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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