CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Had accepted gene therapy before;
Tumor size more than 25cm;
Severe virus infection such as HBV,HCV,HIV,et al
Known HIV positivity
Trial design
Design model
Parallel
Treatments tested in this trial
Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells
Biological/VaccineEngineering 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.
Treatment groups
200 Participants
are divided into 5 treatment groupsGroup A: CAR-NK cell therapy groupExperimental treatment 1 intervention
Group B: IL7/CCL19 secreting CAR-NK cell therapy groupExperimental treatment 1 intervention
Group C: PD1/PDL1/CTLA4-scfv secreting CAR-NK cell therapy groupExperimental treatment 1 intervention
Group D: CAR-NK cell plus CBD therapy groupExperimental treatment 1 intervention
Group E: CAR-NK cell plus NAD therapy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
After CAR-NK cells infusion, up to 52 weeks.Secondary outcomes
1
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.
Time frame
After CAR-NK cells infusion, up to 52 weeks.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.
Time frame
up to 52 weeks.3
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.
Time frame
up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov