CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors
NCT ID: NCT05410717
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2022-06-01
2036-05-31
Brief Summary
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Detailed Description
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2. Perform PBMCs apheresis from the patient and isolate NK cells, transfect the NK cells with Claudin6, GPC3, Mesothelin, or AXL targeting CAR, amplify the number of transfected NK cells as needed, test the quality and killing activity of the Claudin6, GPC3, Mesothelin, or AXL-CAR-NK cells and then transplant back the patients via systemic or local infusions (via artery or intra-tumor), and follow up closely to collect related results as needed;
3. To enhance the killing capability, some CAR-NK cells are genetically engineered to express and secret IL7/CCL19 and/or SCFVs against PD1/CTLA4/Lag3; some CAR-NK cells are combined with Cannabidiol(CBD) or Nicotinamide adenine dinucleotide (NAD);
4. Evaluate the clinical results as needed.
5. Will also perform the similar clinical trial on different cancer types with Claudin6, GPC3, Mesothelin, or AXL expression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CAR-NK cell therapy group
Appropriate patients who could benefit from the Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cell therapy against solid cancers are chosen to be the CAR-NK cell therapy group.
Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells
Engineering Claudin6, GPC3, Mesothelin, or AXL targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Lag3 secreting vector into NK cells, which are isolated from patients with advanced ovarian cancer or other cancers with expression of Claudin6, GPC3, Mesothelin, or AXL, and then transfusing them back the patients.
In some cases, the CAR-NK cells will be combined with CBD or NAD to enhance the therapeutic efficacy.
IL7/CCL19 secreting CAR-NK cell therapy group
Appropriate patients who could benefit from the Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cell therapy against solid cancers are chosen to be the IL7/CCL19 secreting CAR-NK cell therapy group.
Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells
Engineering Claudin6, GPC3, Mesothelin, or AXL targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Lag3 secreting vector into NK cells, which are isolated from patients with advanced ovarian cancer or other cancers with expression of Claudin6, GPC3, Mesothelin, or AXL, and then transfusing them back the patients.
In some cases, the CAR-NK cells will be combined with CBD or NAD to enhance the therapeutic efficacy.
PD1/PDL1/CTLA4-scfv secreting CAR-NK cell therapy group
Appropriate patients who could benefit from the Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cell therapy against solid cancers are chosen to be the PD1/PDL1/CTLA4-scfv secreting CAR-NK cell therapy group.
Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells
Engineering Claudin6, GPC3, Mesothelin, or AXL targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Lag3 secreting vector into NK cells, which are isolated from patients with advanced ovarian cancer or other cancers with expression of Claudin6, GPC3, Mesothelin, or AXL, and then transfusing them back the patients.
In some cases, the CAR-NK cells will be combined with CBD or NAD to enhance the therapeutic efficacy.
CAR-NK cell plus CBD therapy group
Appropriate patients who could benefit from the Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cell therapy against solid cancers are chosen to be the CAR-NK cell plus CBD therapy group.
Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells
Engineering Claudin6, GPC3, Mesothelin, or AXL targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Lag3 secreting vector into NK cells, which are isolated from patients with advanced ovarian cancer or other cancers with expression of Claudin6, GPC3, Mesothelin, or AXL, and then transfusing them back the patients.
In some cases, the CAR-NK cells will be combined with CBD or NAD to enhance the therapeutic efficacy.
CAR-NK cell plus NAD therapy group
Appropriate patients who could benefit from the Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cell therapy against solid cancers are chosen to be the CAR-NK cell plus NAD therapy group.
Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells
Engineering Claudin6, GPC3, Mesothelin, or AXL targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Lag3 secreting vector into NK cells, which are isolated from patients with advanced ovarian cancer or other cancers with expression of Claudin6, GPC3, Mesothelin, or AXL, and then transfusing them back the patients.
In some cases, the CAR-NK cells will be combined with CBD or NAD to enhance the therapeutic efficacy.
Interventions
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Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells
Engineering Claudin6, GPC3, Mesothelin, or AXL targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Lag3 secreting vector into NK cells, which are isolated from patients with advanced ovarian cancer or other cancers with expression of Claudin6, GPC3, Mesothelin, or AXL, and then transfusing them back the patients.
In some cases, the CAR-NK cells will be combined with CBD or NAD to enhance the therapeutic efficacy.
Eligibility Criteria
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Inclusion Criteria
2. Life expectancy \>12 weeks
3. Adequate heart,lung,liver,kidney function
4. Available autologous transduced NK cells with greater than or equal to 20% expression of Claudin6, GPC3, Mesothelin, or AXL-CAR determined by flow-cytometry and killing of claudin6-positive targets greater than or equal to 20% in cytotoxicity assay
5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. -
Exclusion Criteria
2. Tumor size more than 25cm;
3. Severe virus infection such as HBV,HCV,HIV,et al
4. Known HIV positivity
5. History of liver/renal transplantation
6. Active infectious disease related to bacteria, virus,fungi,et al
7. Other severe diseases that the investigators consider not appropriate;
8. Pregnant or lactating women
9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
10. Other conditions that the investigators consider not appropriate. -
18 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Zhenfeng Zhang, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital of Guangzhou Medical University
Locations
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The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Zhenfeng Zhang, MD, PHD
Role: primary
Other Identifiers
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ZZCARNK-017
Identifier Type: -
Identifier Source: org_study_id
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