Your own tumor cells could be the key to fighting cancer
NCT ID NCT05417750
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a personalized immunotherapy for people with advanced solid tumors. Doctors removed a sample of each patient's tumor, grew the immune cells (TILs) in a lab, and then infused them back along with another drug. The goal was to see if this approach is safe and can shrink tumors. The study included 43 patients with cancers like melanoma, cervical cancer, and lung cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tumor-infiltrating lymphocytes (TIL) plus sintilimab
- What this could lead to
- If successful, this could point toward a new immunotherapy option for people with advanced solid tumors like melanoma or cervical cancer.
- What could go wrong
- This is a very early phase 1 trial with only 43 participants, so safety and effectiveness are not yet proven. The treatment involves a complex process and may cause serious 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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
43 people
The number who actually took part.
- Started
-
Oct 2022
- Finished
-
Oct 2025
- 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 to 75 years
- Sex
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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 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. Patients must be ≥18 and ≤75 years of age at the time of consent. 2. Patients with advanced metastatic solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors. 3. At least one measurable target lesion even after resection, as defined by RECIST1.1. Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatments was ≥3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion. 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Patients must have an estimated life expectancy of ≥3 months. 6. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures. 7. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function: * White Blood Cell (WBC)≥2.5×10\^9/L; * Absolute Lymphocyte Count (ANC)≥1.5×10\^9/L; * Absolute Lymphocyte Count(ALC)≥0.7×10\^9/L; * Platelet≥100×10\^9/L; * International Normalized Ratio(INR)≤1.5×ULN; * Activated Partial Thromboplastin Time(APTT)≤1.5×ULN; * Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min * Urinalysis: urine protein less than 2+, or 24-hour urine protein \<1g; * Alanine aminotransferase(AST/SGOT) ≤3×ULN; * Alanine aminotransferase (ALT/SGPT) ≤3×ULN; * Total Bilirubin(TBIL)≤1.5×ULN; 8. Patients must have a washout period ≥ 4 weeks from prior anticancer therapy(ies) to the start of the planned preconditioning regimen, including targeted therapy, chemotherapy, immunotherapy: anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)/anti-PD-1, other monoclonal antibody (mAb), or vaccine Palliative radiation therapy. 9. Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy. 10. Patients must have no contraindications for surgery or biopsy. 11. Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period. Exclusion Criteria: 1. Patients have not recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0), except for alopecia or vitiligo, prior to Enrollment (tumor resection). 2. Patients who have received an organ allograft or prior cell transfer therapy. 3. Patients with symptomatic and/or untreated brain metastases (of any size and any number). 4. Patients who are on chronic systemic steroid therapy for any reason. 5. Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system. 6. Patients with systemic active infection requiring treatment, with positive blood culture or imaging evidence of infection, including active tuberculosis. 7. Patients with hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe cirrhosis, or liver failure. 8. Uncontrolled arterial hypertension(SBP≥160mmHg and/or DBP≥100mmHg)or any unstable cardiovascular or cerebrovascular disease in the recent 6 months of consent. 9. Patients who have a left ventricular ejection fraction (LVEF) \< 50% or New York Heart Association (NYHA) functional classification Class 3 or Class 4. 10. Female patients who are pregnant or breastfeeding. 11. Patients who are HIV positive, positive syphilis serological test, positive COVID-19 nucleic acid test, or clinically active hepatitis A, B, and C including virus carriers.
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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.
Contacts and locations
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039, China
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