Could your own tumor cells fight your cancer? early trial begins
NCT ID NCT04967833
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This early-phase trial tests a personalized therapy for people with advanced solid tumors that have not responded to standard treatments. Doctors take immune cells from a sample of the patient's tumor, grow them into large numbers in a lab, and infuse them back into the patient. The goal is to see if this approach is safe and can shrink tumors. Only 20 participants will be enrolled.
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 (TILs) – immune cells taken from the patient's tumor, multiplied in a lab, and infused back
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is a very early, small trial (20 people) focused on safety. The treatment involves strong chemotherapy beforehand, which can cause serious side effects. Success is not guaranteed.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- Expected to finish
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Apr 2029
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 years to 75 years; 2. Histologically diagnosed as primary/relapsed/metastasized malignant tumors; 3. Expected life-span more than 3 months; 4. Karnofsky≥60% or ECOG score 0-2; 5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available. 6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated; 7. At least 1 evaluable tumor lesion; 8. Hematology and Chemistry(within 7 days prior to enrollment): * Absolute count of white blood cells≥2.5×10\^9/L; * Absolute count of neutropils≥1.5×10\^9/L; * Absolute count of lymphocytes ≥0.7×109/L; * Platelet count≥100×10\^9; * hemoglobin≥90 g/L; * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); * Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min; * Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN); * Totol bilirubin≤1.5×ULN; 9. No absolute or relative contraindications to operation or biopsy; 10. Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion; 11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs; 12. Be able to understand and sign the informed consent document; 13. Be able to stick to follow-up visit plan and other requirements in the agreement. Exclusion Criteria: 1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment; 2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%; 3. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc. 4. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive; 5. Severe physical or mental diseases; 6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection); 7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy; 8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy; 9. Having received immunotherapy and developed irAE level greater than Level 3; 10. Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded); 11. Females in pregnancy or lactation; 12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy; 13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical 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 places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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Tongren Hospital Shanghai Jiao Tong University School Of Medicine.
RECRUITINGShanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug shrink advanced solid tumors?
- Can a drug duo outsmart a common cancer mutation?
- Can a drug duo shrink Hard-to-Treat tumors?
- Can a cocktail of immune boosters shrink Hard-to-Treat tumors?