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Cell therapy combo aims to boost kidney cancer treatment

NCT ID NCT07087158

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether adding an experimental cell therapy called IBR854 to the standard drug pazopanib works better than pazopanib alone for advanced kidney cancer. About 30 adults with untreated advanced clear cell renal cell carcinoma will take part. The goal is to see if the combination slows cancer growth and improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IBR854 (a cell therapy) combined with pazopanib (a targeted drug)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced kidney cancer that hasn't been treated before.
What could go wrong
This is an early phase 2 trial with only 30 participants, so results may not apply broadly. Cell therapies can cause serious side effects like immune reactions.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, age ≥ 18 years old 2. Advanced clear cell renal cell carcinoma confirmed by histology or cytology and not amenable to curative surgery. 3. Has not received any previous systemic anti-tumor treatment for advanced renal cell carcinoma. 4. Expected survival period is at least 3 months. 5. ECOG performance status of 0 or 1, or KPS score of at least 70. 6. Has measurable disease per RECIST 1.1. 7. Organ function should meet the following criteria: 1. Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; Platelet (PLT) ≥90×10\^9/L; Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion or hematopoietic stimulator treatment within 7 days). 2. Albumin ≥ 30 g/L; Total bilirubin ≤1.5×ULN (for subjects with Gilbert's syndrome, it can be ≤3×ULN); ALT and AST ≤1.5×ULN (If liver metastasis is combined, ALT and AST≤3×ULN). 3. Creatinine (Cr) ≤1.5 × ULN; Creatinine clearance (Ccr) (to be calculated only when Cr \> 1.5× ULN) \> 50 ml/min (Cockcroft-Gault formula). 4. Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN. 8. Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures. Exclusion Criteria: 1. Documented central nervous system metastases. 2. Received prior antineoplastic therapy (including chemotherapy, biologic therapy, immunotherapy, or Chinese traditional medicines with antitumor indications) before the first dose of study treatment. 3. Has received major surgery (grade 3 or 4 as defined in the Measures for the Administration of Clinical Application of Medical Technology) within 28 days before the first dose of study treatment and has not yet recovered from which; or any planned curative surgery for renal cell carcinoma during the study. 4. History of another malignancy within 5 years before the first dose of study treatment, except for Lung carcinoma in situ, low-risk early-stage prostate cancer, or cured basal-cell carcinoma, squamous-cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma. 5. Clinically significant gastrointestinal abnormalities such as malabsorption syndrome, major gastric or small-bowel resection that may affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other conditions increasing the risk of perforation; or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the first dose of study treatment. 6. Systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive agents required within 2 weeks before the first dose or anticipated during study treatment, except for: 1. Topical, intranasal, or inhaled corticosteroids. 2. Corticosteroids as premedication for infusion-related or hypersensitivity reactions (e.g., premedication for CT imaging). 3. Replacement therapy such as levothyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency. 4. Low-dose corticosteroids for orthostatic hypotension. 7. Clinically significant cardiovascular or cerebrovascular disease documented by any of the following: 1. Ischemic stroke (excluding silent lacunar infarction) or severe thromboembolic event within 6 months before the first dose of study treatment. 2. Myocardial infarction, unstable angina, congestive heart failure, or clinically significant arrhythmia within 6 months before the first dose of study treatment. 3. New York Heart Association (NYHA) class ≥ II heart failure before the first dose of study treatment. 4. QTcF interval \>450 ms (men) or \>470 ms (women) before the first dose of study treatment. 5. Left-ventricular ejection fraction (LVEF) ≤50 % before the first dose of study treatment. 8. Prior organ transplant, except corneal transplant; prior allogeneic stem-cell transplant. 9. Hepatitis B surface antigen (HBsAg) positive with HBV DNA \>500 IU/mL or \>2,500 copies/mL, or hepatitis C antibody positive with detectable HCV RNA, or known HIV infection, or active tuberculosis. 10. Interstitial lung disease or non-infectious pneumonitis that is currently symptomatic or has previously required systemic corticosteroids, in the opinion of the investigator likely to interfere with toxicity assessment or management. 11. Any severe, progressive, or uncontrolled medical condition that, in the investigator's judgment, makes the subject unsuitable for the study, including but not limited to: 1. Infection requiring systemic therapy. 2. Symptomatic pleural, pericardial, or ascitic fluid requiring or having undergone drainage within 2 weeks before the first dose (minimal asymptomatic effusion, third-spacing due to hypoalbuminaemia, or cases where benefit outweighs risk may be allowed). 3. History of coagulopathy (e.g., deep-vein thrombosis) or severe bleeding diathesis; clinically significant bleeding event (e.g., gastrointestinal bleeding) within 1 month before the first dose. 4. History of severe psychiatric disorder. 5. Any other condition that, in the investigator's opinion, renders study participation riskier than beneficial. 12. Prior grade 3-4 immune-related adverse events that, in the investigator's judgment, should be excluded. 13. Severe allergic or hypersensitivity disorders, significant drug allergies (including to investigational agents), or known hypersensitivity to any component of the study drug, including severe reactions to monoclonal antibodies. 14. Participation in another clinical trial and receipt of an investigational agent within 28 days before the first dose of study treatment. 15. Clinically significant organ dysfunction or comorbidity likely to interfere with protocol adherence. 16. Live vaccine received within 30 days before the first dose, or planned during the study or within 1 month after the last dose. 17. Pregnant or breast-feeding women (women who agree to discontinue breast-feeding before signing informed consent may be enrolled). 18. Any other condition or circumstance that, in the investigator's opinion, unsuitable for participation.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • The Cancer Hospital of Fudan University

    RECRUITING

    Shanghai, China

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Other studies related to the condition(s) this trial covers.