Can immune cells shrink Hard-to-Treat tumors?
NCT ID NCT07784777
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether infusions of natural killer (NK) cells—a type of immune cell from a healthy donor—can safely help people with advanced solid tumors that have not responded to standard treatments. The study enrolls about nine adults aged 18 to 75 and uses a step-by-step dose escalation to find the safest and most promising dose. Participants receive the NK cells after a short course of chemotherapy to prepare the body, and researchers monitor side effects, how the cells behave, and any signs of tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Allogeneic natural killer (NK) cell therapy (non-genetically modified)
- What this could lead to
- If this works, it could point toward a new treatment option for advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is an early, small phase 1 trial focused on safety and dosing, so it may not show clear benefit. There are risks of side effects from the cells and the chemotherapy given beforehand.
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 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
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 (inclusive), regardless of sex; 2. Histologically or cytologically confirmed advanced solid tumor; 3. Failed standard treatment, or no standard treatment available, or standard treatment not currently applicable; 4. At least one measurable lesion per RECIST 1.1 (non-lymph node lesion \>= 1.0 cm in long diameter, or lymph node lesion \>= 1.5 cm in short diameter); lesions previously treated with local therapy (e.g., radiotherapy or interventional therapy) cannot be considered target lesions unless there is imaging evidence of definitive progression; 5. Adequate bone marrow and organ function: * ANC \>= 1.5 x 10\^9/L; * Platelet count \> 100 x 10\^9/L; * Hemoglobin \>= 9 g/dL; * Total bilirubin \< 1.5 x ULN; ALT and AST \< 3 x ULN (for liver metastases or primary hepatocellular carcinoma: total bilirubin \< 2.5 x ULN, ALT and AST \< 5 x ULN); * Serum creatinine \<= 1.5 x ULN; * PT, APTT, INR \< 1.5 x ULN; 6. ECOG performance status 0-1; 7. Expected survival \>= 3 months; 8. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to cell infusion, and must agree to use reliable contraception during the study and for 6 months after cell infusion; male participants with partners of childbearing potential must agree to use reliable contraception during the study and for 6 months after cell infusion; 9. Willing to participate voluntarily and sign the informed consent form (ICF), and able to comply with follow-up requirements. Exclusion Criteria: 1. Other malignancies within 5 years prior to screening (except completely resolved carcinoma in situ and malignancies judged by the investigator to be slow-progressing); 2. History of leptomeningeal metastasis or CNS metastasis, or definite CNS underlying disease with significant residual symptoms within 6 months prior to cell infusion (asymptomatic brain metastasis or stable symptoms after treatment without corticosteroid use may be allowed); 3. Clinically symptomatic moderate to severe third-space effusion requiring therapeutic drainage (except for minimal effusion on imaging without clinical symptoms); 4. Severe cardiovascular disease history, including but not limited to: severe arrhythmia or conduction abnormalities requiring clinical intervention; QTcF \> 450 ms (male) or \> 470 ms (female); acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other \>= Grade 3 cardiovascular events within 6 months prior to screening; NYHA functional classification \>= II or LVEF \< 50%; uncontrolled hypertension (SBP \>= 160 mmHg and/or DBP \>= 100 mmHg); 5. Any active infection (viral, bacterial, fungal) currently under treatment, or any infection requiring \>= 7 days of IV antibiotics within the past 6 weeks, or any active infection requiring oral antibiotics within the past 1 week; 6. Active autoimmune disease or history of severe autoimmune disease requiring long-term immunosuppressive therapy; 7. Allergy to lymphodepleting chemotherapy (cyclophosphamide, fludarabine) and/or any component of the study product; 8. Prior treatment with other cell therapy products (e.g., DC, CIK, T cells, NK cells, CAR-T, etc.) other than the study product; 9. Received other anti-tumor treatment (chemotherapy, targeted therapy, immunotherapy, interventional therapy, or Chinese patent medicine with anti-tumor indications) within 4 weeks prior to infusion; 10. Participated in other clinical trials within 3 months prior to infusion; 11. Toxicity or complications from prior intervention or treatment not resolved to Grade 2 or below (except alopecia and \<= Grade 2 peripheral sensory neuropathy); 12. Untreated chronic active hepatitis B, or chronic HBV carrier with HBV DNA \>= 1000 copies/mL; HCV antibody positive and HCV-RNA positive; HIV antibody positive; Treponema pallidum antibody positive; 13. Other severe organic diseases or psychiatric disorders; 14. Pregnant or lactating women; 15. Any other condition that, in the investigator's judgment, makes the participant unsuitable for this 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 study's own enquiry address
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The official record
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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