Non-Small Cell Lung Cancer NSCLCPhase 1/2NCT06454890
Clinical Study of Trop2 CAR-NK in the Treatment of Relapsed/Refractory Non-Small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing Anti-Trop2 CAR-NK cell in people with Non-Small Cell Lung Cancer NSCLC, run by Henan Cancer Hospital.
Trial summary
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-Trop2 U-CAR-NK Cells Therapy combined with Chemotherapy for Relapsed/Refractory Non-Small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Non-Small Cell Lung Cancer NSCLC
- What is being tested?
- Anti-Trop2 CAR-NK cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Jul 2029
- Phase
- Phase 1/2
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-79, male and female;
- Predicted survival ≥12 weeks;
- ECOG score 0-1;
- Diagnosed with Stage IIIB-IV non-small cell lung cancer (NSCLC) through imaging, histological, and/or cytological examinations
- For patients with negative driver genes (EGFR/ALK/ROS-1/BRAF V600E/MET exon 14 mutation/NTRK), failed first-line PD-1/PD-L1 immunotherapy combined with platinum-based doublet chemotherapy; For patients with EGFR-sensitive mutations (19del, 21L858R, 18exonG719X, 20exonS768I, 21exonL861Q), they must meet one of the following requirements: a) Failed treatment with 1st or 2nd generation EGFR-TKI, and histologically confirmed T790M mutation negative after treatment failure; b) Failed treatment with 3rd generation EGFR-TKI regardless of T790M mutation status; For patients with other driver genes positive besides EGFR mutation and have approved first-line targeted therapies, failed first-line targeted therapy;
- Have at least one measurable tumor lesion according to RECIST 1.1;
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- The tumor tissue sample (previous or fresh) shows at least 50% weak positive expression of Trop2 protein;
- Have adequate organ and bone marrow function, defined as follows:
- Blood routine: Absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet (PLT) ≥ 100×109/L, hemoglobin (Hb) ≥ 90g/L; Liver function: Bilirubin \< 1.5 times the upper limit of normal (ULN), alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \< 2.5 times ULN (in case of liver metastasis, ALP, AST, and ALT \< 5 times ULN are allowed); Renal function: Creatinine clearance rate (CCR) ≥ 60 mL/min (using the standard Cockcroft-Gault formula);
- For women: surgically sterilized, postmenopausal patients, or those who agree to use a medically accepted contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during and for 6 months after the study treatment period; serum or urine pregnancy test must be negative within 7 days before study enrollment, and must be non-lactating; For men: surgically sterilized or those who agree to use a medically accepted contraceptive method during and for 6 months after the study treatment period.
Who cannot join
- Severe infection;
- Clinically active brain or meningeal metastasis, defined as untreated and symptomatic, or requiring steroids or anticonvulsant therapy to control related symptoms. For asymptomatic brain metastasis subjects, if they have been stable for at least 4 weeks in imaging and neurologically after receiving targeted therapy for brain metastasis, and are on a stable or reduced dose of steroids equivalent to ≤10 mg/day of prednisone, they may be included in the study;
- Organic heart disease, cardiac insufficiency, heart block above grade II, myocardial infarction within 6 months;
- Active autoimmune disease;
- Interstitial lung disease;
- Active hepatitis B (Hepatitis B surface antigen (HBsAg) positive, HBV-DNA testing required; HBV-DNA ≥500 IU/mL or higher than the lower limit of detection, whichever is higher) or hepatitis C (Hepatitis C antibody positive and HCV-RNA higher than the lower limit of detection);
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- Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
- Pregnancy or lactation;
- Patients with a tendency to bleed, including acute gastrointestinal bleeding, nasal bleeding, hemoptysis, as well as persistent bleeding disorders or coagulation disorders;
- Patients who have used anti-tumor drugs other than immunotherapy within 3 weeks;
- 12. Multiple primary malignancies within 3 years prior to enrollment, except for fully resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer), radically treated carcinoma in situ (e.g., cervical or breast carcinoma in situ), other radically treated solid tumors (e.g., superficial bladder cancer), or contralateral breast cancer; 13. History of allergy to any component of the study drug; 14. Other situations that the investigator deems unsuitable for participation in the study, or other situations that may affect the analysis of the clinical study results.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-Trop2 Universal CAR-NK(U-CAR-NK) Cells Therapy Combined With Chemotherapy for Relapsed/Refractory Non-Small Cell Lung Cancer (NSCLC)
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-Trop2 U-CAR-NK Cells Therapy combined with Chemotherapy for Relapsed/Refractory Non-Small Cell Lung Cancer (NSCLC).
Read the detailed description
Who can participate? Patients who were diagnosed with Non-Small Cell Lung Cancer and tumor cells expressing Trop2.
How to conduct this study? This study is an interventional clinical study. The intervention in the trial is anti-Trop2 U-CAR-NK cells. The administration time is 5 days after chemotherapy. Patients were then evaluated efficacy and safety until 3 years after U-CAR-NK cells infusion.
What are the possible benefits and risks of participating? Benefits: The effect of anti-tumor of NK cells may be used to disease control.
Risks: Subjects may have adverse reactions to the treatment. These adverse reactions may include abnormal liver injury, fever, and possibly other unknown adverse reactions.
Where is the study run? Henan Cancer Hospital.
- Conditions
- Non-Small Cell Lung Cancer NSCLC
- Being tested
- Anti-Trop2 CAR-NK cell
- Keywords
- CAR-NK, TROP2, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Trop2 CAR-NK cellBiological
chemotherapy followed by Trop2 CAR-NK infusion
| Study group | Role | What they receive |
|---|---|---|
| Anti-Trop2 CAR-NK cell therapy group | Experimental | chemotherapy followed by Trop2 CAR-NK infusion Receives: Biological: Anti-Trop2 CAR-NK cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
The type, frequency, severity, and duration of adverse events as a result of Trop2 CAR-NK cells infusion will be summarized.
Measured: Up to 1 year
Objective Response Rate (ORR)
Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1) assessed by MRI or CT. ORR defined as the proportion of patients in whom a complete response (CR) or partial response (PR) is observed as best overall response, prior to progression or further anti-cancer therapy.
Measured: up to 1 year.
Secondary outcomes (2)
Disease control rate (DCR)
Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, SD assessed at least 6 weeks after the first dose) is observed as best overall response.
Measured: up to 1 year.
Overall survival (OS)
To determine the anti-tumor effectivity
Measured: up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer NSCLCStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qiming Wang, Henan Cancer Hospital
- Investigators
- Qiming Wang PhD, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454890
- Sponsor's protocol ID
- CHH-101-NSCLC
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-Trop2 Universal CAR-NK(U-CAR-NK) Cells Therapy Combined With Chemotherapy for Relapsed/Refractory Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT06454890
- Acronym / sponsor ID
- CHH-101-NSCLC
- Conditions
- Non-Small Cell Lung Cancer NSCLC
- Keywords
- CAR-NK, TROP2, NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 12 Jun 2024 (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.
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-Trop2 U-CAR-NK Cells Therapy combined with Chemotherapy for Relapsed/Refractory Non-Small Cell Lung Cancer (NSCLC).
Detailed description
Who can participate? Patients who were diagnosed with Non-Small Cell Lung Cancer and tumor cells expressing Trop2.
How to conduct this study? This study is an interventional clinical study. The intervention in the trial is anti-Trop2 U-CAR-NK cells. The administration time is 5 days after chemotherapy. Patients were then evaluated efficacy and safety until 3 years after U-CAR-NK cells infusion.
What are the possible benefits and risks of participating? Benefits: The effect of anti-tumor of NK cells may be used to disease control.
Risks: Subjects may have adverse reactions to the treatment. These adverse reactions may include abnormal liver injury, fever, and possibly other unknown adverse reactions.
Where is the study run? Henan Cancer Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-Trop2 CAR-NK cell therapy group | Experimental | Biological: Anti-Trop2 CAR-NK cellchemotherapy followed by Trop2 CAR-NK infusion |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-79, male and female;
- Predicted survival ≥12 weeks;
- ECOG score 0-1;
- Diagnosed with Stage IIIB-IV non-small cell lung cancer (NSCLC) through imaging, histological, and/or cytological examinations
- For patients with negative driver genes (EGFR/ALK/ROS-1/BRAF V600E/MET exon 14 mutation/NTRK), failed first-line PD-1/PD-L1 immunotherapy combined with platinum-based doublet chemotherapy; For patients with EGFR-sensitive mutations (19del, 21L858R, 18exonG719X, 20exonS768I, 21exonL861Q), they must meet one of the following requirements: a) Failed treatment with 1st or 2nd generation EGFR-TKI, and histologically confirmed T790M mutation negative after treatment failure; b) Failed treatment with 3rd generation EGFR-TKI regardless of T790M mutation status; For patients with other driver genes positive besides EGFR mutation and have approved first-line targeted therapies, failed first-line targeted therapy;
Key exclusion criteria (11 listed)
- Severe infection;
- Clinically active brain or meningeal metastasis, defined as untreated and symptomatic, or requiring steroids or anticonvulsant therapy to control related symptoms. For asymptomatic brain metastasis subjects, if they have been stable for at least 4 weeks in imaging and neurologically after receiving targeted therapy for brain metastasis, and are on a stable or reduced dose of steroids equivalent to ≤10 mg/day of prednisone, they may be included in the study;
- Organic heart disease, cardiac insufficiency, heart block above grade II, myocardial infarction within 6 months;
- Active autoimmune disease;
- Interstitial lung disease;
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 |
|---|---|---|
| Anti-Trop2 CAR-NK cellchemotherapy followed by Trop2 CAR-NK infusion | Biological | Anti-Trop2 CAR-NK cell therapy group |
Primary outcome
Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Time frame: Up to 1 year
The type, frequency, severity, and duration of adverse events as a result of Trop2 CAR-NK cells infusion will be summarized.
Objective Response Rate (ORR)
Time frame: up to 1 year.
Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1) assessed by MRI or CT. ORR defined as the proportion of patients in whom a complete response (CR) or partial response (PR) is observed as best overall response, prior to progression or further anti-cancer therapy.
2 secondary outcomes
Disease control rate (DCR)
Time frame: up to 1 year.
Overall survival (OS)
Time frame: up to 3 years.
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 12 Jun 2024.
- 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.
Qiming Wang PhD principal investigator
Henan Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anti-Trop2 CAR-NK cell in people with Non-Small Cell Lung Cancer NSCLC, run by Henan Cancer Hospital.
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 10 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Qiming Wang PhD (+8613783590691, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0 (time frame: Up to 1 year). 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 12 Jun 2024.