Phase I Trial to Evaluate Safety and Preliminary Efficacy of CLDN6/GPC3/Mesothelin/AXL-CAR-NK in Patients With CLDN6/GPC3/Mesothelin/AXL-positive Advanced Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is an open, exploratory clinical study to evaluate the safety and preliminary efficacy of Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells in patients with Claudin6, GPC3, Mesothelin, or AXL-positive advanced solid tumors (ovarian cancer and others)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• patients with advanced ovarian cancer or other cancers with expression of claudin6.

• Life expectancy \>12 weeks

• Adequate heart,lung,liver,kidney function

• 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

• Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. -

Locations
Other Locations
China
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Zhenfeng Zhang, MD, PHD
zhangzhf@gzhmu.edu.cn
+862039195966
Backup
Bingjia He, MD
464677938@qq.com
+862039195965
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2036-05-31
Participants
Target number of participants: 200
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Endometrial Cancer
Testicular Cancer
Ovarian Cancer
Sponsors
Leads: Second Affiliated Hospital of Guangzhou Medical University

This content was sourced from clinicaltrials.gov

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