Donor cells join fight against advanced cancers
NCT ID NCT07551778
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times
Summary
This early study tests whether adding donor natural killer (NK) cells to standard maintenance therapy can safely help control advanced lung and colorectal cancers. About 20 adults will receive NK cell infusions alongside their usual drugs. The main goal is to check for side effects, with a secondary look at whether tumors shrink or stop growing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- donor natural killer (NK) cells
- What this could lead to
- If it works, this could point toward a new way to boost the immune system to better control advanced solid tumors.
- What could go wrong
- This is a very early, small trial (20 people) testing safety first. The NK cells may not shrink tumors or could cause serious side effects like immune overreaction.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Apr 2029
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 to 75 years
- 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 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 18-75 years, either gender 2. Subjects must meet one of the following conditions: Cohort 1, Cohort 3: * Histologically/cytologically confirmed locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (Stage IIIB\~IV), without known drug-targetable driver mutations (including but not limited to: EGFR sensitive mutations, ALK gene rearrangements, ROS1 mutations, BRAF 600E mutations, KRAS mutations); * Previously received 4\~6 cycles of first-line induction therapy with PD-(L)1 combined with pemetrexed and platinum (cycles not combined with chemotherapy are not counted as combined treatment cycles), and imaging assessment shows non-progressive disease (i.e., CR, PR, or SD per RECIST 1.1). 3. Cohort 2: * Histologically/cytologically confirmed locally advanced unresectable or metastatic (unresectable Stage III or Stage IV per AJCC 8th Edition) colorectal adenocarcinoma; * Previously received 6\~9 cycles of first-line induction therapy with cetuximab/bevacizumab combined with FOLFOX/FOLFIRI (cycles not combined with chemotherapy are not counted as combined treatment cycles), and imaging assessment shows non-progressive disease (i.e., CR, PR, or SD per RECIST 1.1). 4. Cohort 4: * Histologically/cytologically or clinically diagnosed (by dynamic enhanced MRI/dynamic enhanced CT scan, etc.) locally advanced unresectable or metastatic hepatocellular carcinoma; * Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B (not suitable for surgery/locoregional therapy, including ablation, intervention, and radiotherapy); * Child-Pugh score ≤ 7 (Child-Pugh A/B), with no history of hepatic encephalopathy; * No prior systemic anti-tumor therapy for HCC; * According to RECIST 1.1, at least one measurable lesion exists: non-lymph node lesion long diameter ≥ 1.0 cm, or lymph node lesion short diameter ≥ 1.5 cm; lesions that have received locoregional therapy (e.g., radiotherapy or interventional therapy) cannot be considered target lesions unless there is imaging evidence confirming definite progression of the lesion. 5. Cohort 5: * Pathologically histologically or cytologically diagnosed locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, with HER2 low or negative expression; * Previously received 6\~9 cycles of first-line induction therapy with PD-(L)1 combined with oxaliplatin and fluoropyrimidine-based chemotherapy (cycles not combined with chemotherapy are not counted as combined treatment cycles), and imaging assessment shows non-progressive disease (i.e., CR, PR, or SD per RECIST 1.1). 6. Prior neoadjuvant/adjuvant chemotherapy is permitted, provided that disease recurrence or metastasis occurs more than 6 months after the last dose of chemotherapy 7. Adequate bone marrow and organ function: 1. ANC ≥1.5×10⁹/L; Platelet \>90×10⁹/L; Hemoglobin \>9 g/dL 2. Liver function: Total bilirubin \<1.5×ULN; ALT and AST \<3×ULN (\<5×ULN if liver metastases present) 3. Renal function: Serum creatinine ≤1.5×ULN 4. Coagulation: PT, APTT, INR \<1.5×ULN 8. ECOG performance status 0-1 9. Life expectancy ≥3 months 10. Non-pregnant, non-lactating; women of childbearing potential must have negative serum pregnancy test within 7 days before cell infusion and agree to use reliable contraception during study and for 6 months after last infusion; men with partners of childbearing potential must agree to use reliable contraception 11. Voluntary informed consent and able to comply with follow-up Exclusion Criteria: 1. Prior treatment with other cellular therapy products (DC, CIK, T cells, NK cells, CAR-T, etc.) except this product 2. Other malignancies within 5 years before screening (completely resolved carcinoma in situ and slowly progressing malignancies as determined by investigator excluded) 3. Symptomatic moderate to severe third-space effusion requiring therapeutic drainage 4. Gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months 5. As assessed by the investigator, intrahepatic tumor mass occupies more than 50% of the entire liver, or tumor thrombus invades major blood vessels (such as the main portal vein, superior mesenteric vein, or inferior vena cava), leading to complications such as portal hypertension or related clinical risks. 6. Significant cardiovascular disease history including 7. Arterial or venous thrombotic events within 6 months before enrollment (CVA, DVT, PE, etc.) 8. Active infection (viral, bacterial, fungal) currently being treated, or any infection requiring IV antibiotics for ≥7 days within past 6 weeks, or oral antibiotics within past 1 week 9. Active autoimmune disease or history of severe autoimmune disease requiring long-term immunosuppression 10. Participation in other interventional clinical trials within 3 months 11. Toxicities from prior interventions not resolved to Grade ≤2 (alopecia excluded) 12. Untreated chronic active hepatitis B, chronic HBV carriers with HBV DNA ≥1000 copies/mL; HCV antibody positive with HCV-RNA positive; HIV antibody positive; syphilis antibody positive 13. Any other condition deemed by investigator to make subject unsuitable for study participation
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced colorectal adenocarcinoma are added.
By submitting, you agree to our Terms of use
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ivosidenib plus mFOLFOXIRI and celecoxib as a treatment for BRAF-targeted therapy-refractory BRAF V600E-mutant colorectal cancer patients: a phase II study
- Can a new drug shrink advanced solid tumors?
- Can a new drug shrink tumors that resist standard care?
- Can a drug duo outsmart a common cancer mutation?
- A single blood draw to detect five cancers before symptoms appear?
- Can a new drug duo shrink Hard-to-Treat tumors?