Relapsed/Refractory Solid TumorsPhase 1NCT05528341
NKG2D-CAR-NK92 Cells Immunotherapy for Solid Tumors
A Phase 1 study testing NKG2D-CAR-NK92 cells in people with Relapsed/Refractory Solid Tumors, run by Henan Medical University at 1 site in China.
Trial summary
The purpose of this clinical investigation is to evaluate the safety and effects of NKG2D-CAR-NK92 infusions in the treatment of relapsed/refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Solid Tumors
- What is being tested?
- NKG2D-CAR-NK92 cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2023to Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 18 years old and ≤ 75 years old, male or female.
- Histopathology confirmed the diagnosis of malignant tumors (including breast cancer, lung cancer, gastric cancer, ovarian cancer, cervical cancer, renal carcinoma, malignant melanoma, osteosarcoma and lymphoma).
- Expected survival time ≥3 months.
- Disease must be measurable according to the corresponding guidelines.
- Fail or unwilling to receive third-line treatment.
- ECOG: 0-2.
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- The last cytotoxic drug, radiotherapy or surgery≧4 weeks.
- HB≧90g/L, ANC≧1.5×10^9/L, PLT≧80×10^9/L, TBIL≦1.5×upper limit of normal, ALT/AST≦2.5×upper limit of normal, ALT/AST≦5×upper limit of normal if have liver metastasis, Cr≦1.5×upper limit of normal or CCr≧60ml/min.
- Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test;
- Written informed consent form must be signed before enrollment.
- Patient with MICA/B+ cell tumors confirmed by pathology and histology.
Who cannot join
- The patient has other malignancies or has been diagnosed with other malignancies within the last 5 years (except clinically cured carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, and thyroid papillary carcinoma).
- Patients with brain metastases with symptoms or with symptom control for less than 3 months.
- Active autoimmune disease.
- Severe autoimmune diseases or congenital immunodeficiency.
- Concomitant serious infection or other serious underlying medical condition.
- Active hepatitis patients (including hepatitis B and C).
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- History of severe immediate hypersensitivity to any of the biological products including penicillin.
- Drug abuse, medical, psychological or social conditions that may interfere with a subject's participation in the study or evaluation of the results of the study.
- Simultaneous participation in another clinical trial within 4 weeks.
- Cell therapy or gene therapy in the previous 1 month.
- A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation.
- Investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453000
Professor Lu, 13598722864
About this study
Official title: Clinical Investigation of NKG2D-CAR-NK92 Chimeric Antigen Receptor Modified NK92 Cells in the Treatment of Relapsed/Refractory Solid Tumors
The purpose of this clinical investigation is to evaluate the safety and effects of NKG2D-CAR-NK92 infusions in the treatment of relapsed/refractory solid tumors.
- Conditions
- Relapsed/Refractory Solid Tumors
- Being tested
- NKG2D-CAR-NK92 cells
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKG2D-CAR-NK92 cellsBiological
NKG2D-CAR-NK92 cells will be administered intravenously over 1h. The starting dose of NKG2D-CAR-NK92 cells will be 0.5×10^6-2×10^6/kg, twice a week. The first evaluation of the efficacy after 3 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| NKG2D-CAR-NK92 cells immunotherapy | Experimental | Preparation of NKG2D-CAR-NK92 cells suspended in saline solution. Receives: Biological: NKG2D-CAR-NK92 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events evaluated with CTCAE, version 4.0
Safety evaluation
Measured: 3 months
Objective Response Rate
Solid tumors to NKG2D-CAR-NK92 cells infusions
Measured: up to one year
Secondary outcomes (4)
Disease Control Rate
Measured: up to one year
Progression-free Survival
Measured: up to one year
Overall Survival
Measured: up to one year
Quality of Life Score
We use the 26 items self-rating questionnaire WHOQOL-BREF to assess the Quality of Life Score, which measures physical health, psychological health, social relationships, and environment during the last two weeks.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start26 Jan 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528341
- Sponsor's protocol ID
- CNK-102
- Status last verified
- Apr 2025
- First submitted
- 31 Aug 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of NKG2D-CAR-NK92 Chimeric Antigen Receptor Modified NK92 Cells in the Treatment of Relapsed/Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT05528341
- Acronym / sponsor ID
- CNK-102
- Conditions
- Relapsed/Refractory Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henan Medical UniversityUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical investigation is to evaluate the safety and effects of NKG2D-CAR-NK92 infusions in the treatment of relapsed/refractory solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NKG2D-CAR-NK92 cells immunotherapy | Experimental | Biological: NKG2D-CAR-NK92 cellsPreparation of NKG2D-CAR-NK92 cells suspended in saline solution. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: ≥ 18 years old and ≤ 75 years old, male or female.
- Histopathology confirmed the diagnosis of malignant tumors (including breast cancer, lung cancer, gastric cancer, ovarian cancer, cervical cancer, renal carcinoma, malignant melanoma, osteosarcoma and lymphoma).
- Expected survival time ≥3 months.
- Disease must be measurable according to the corresponding guidelines.
- Fail or unwilling to receive third-line treatment.
Key exclusion criteria (12 listed)
- The patient has other malignancies or has been diagnosed with other malignancies within the last 5 years (except clinically cured carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, and thyroid papillary carcinoma).
- Patients with brain metastases with symptoms or with symptom control for less than 3 months.
- Active autoimmune disease.
- Severe autoimmune diseases or congenital immunodeficiency.
- Concomitant serious infection or other serious underlying medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NKG2D-CAR-NK92 cellsNKG2D-CAR-NK92 cells will be administered intravenously over 1h. The starting dose of NKG2D-CAR-NK92 cells will be 0.5×10^6-2×10^6/kg, twice a week. The first evaluation of the efficacy after 3 weeks of treatment. | Biological | NKG2D-CAR-NK92 cells immunotherapy |
Primary outcome
Number of participants with adverse events evaluated with CTCAE, version 4.0
Time frame: 3 months
Safety evaluation
Objective Response Rate
Time frame: up to one year
Solid tumors to NKG2D-CAR-NK92 cells infusions
4 secondary outcomes
Disease Control Rate
Time frame: up to one year
Progression-free Survival
Time frame: up to one year
Overall Survival
Time frame: up to one year
Quality of Life Score
Time frame: up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NKG2D-CAR-NK92 cells in people with Relapsed/Refractory Solid Tumors, run by Henan Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wuling Zhu (008603733029089, wulingzhu@xxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events evaluated with CTCAE, version 4.0 (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.