Donor cells join fight against advanced cancers

NCT ID NCT07551778

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

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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

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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 ↗

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Contacts and locations

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