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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-NK cell therapy group | Experimental | 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. |
|
| IL7/CCL19 secreting CAR-NK cell therapy group | Experimental | 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. |
|
| PD1/PDL1/CTLA4-scfv secreting CAR-NK cell therapy group | Experimental | 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. |
|
| CAR-NK cell plus CBD therapy group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0 | The type, frequency, severity, and duration of adverse events as a result of Claudin6, GPC3, Mesothelin, or AXL- CAR-NK cells infusion will be summarized. | After CAR-NK cells infusion, up to 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After CAR-NK cells infusion, up to 52 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenfeng Zhang, MD, PHD | Contact | +862039195966 | zhangzhf@gzhmu.edu.cn | |
| Bingjia He, MD | Contact | +862039195965 | 464677938@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenfeng Zhang, MD, PHD | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C122101 | claudin 6 |
| D000090204 | Mesothelin |
| ID | Term |
|---|---|
| D058851 | GPI-Linked Proteins |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| CAR-NK cell plus NAD therapy group |
| Experimental |
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. |
|
|
| 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. | up to 52 weeks. |
| Duration of response (DOR) | Duration of response (DOR) defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (Progressive disease (PD) per RECIST 1.1/recurrence) or death from any cause, whichever occurs first. | up to 36 months |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D013733 | Testicular Diseases |
| D002241 |
| Carbohydrates |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D058635 | Lipid-Linked Proteins |
| D008565 | Membrane Proteins |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |