CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors

NCTNCT05410717Other idZZCARNK-017

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 1
Enrollment: 200 participants (estimated)
Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 1 Jun 2022
Primary completion: 1 Jun 2030 (estimated)
Completion: 31 May 2036 (estimated)
First posted: 8 Jun 2022
Last update posted: 25 Jun 2024
Conditions: Stage IV Ovarian Cancer · Testis Cancer, Refractory · Endometrial Cancer Recurrent · CAR NK

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520302035

Ph 1
CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors
NCT05410717
1 Jun 2022 to est. 31 May 2036

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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)

Interventions

Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cellsBiological

Arms5

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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Time frame · After CAR-NK cells infusion, up to 52 weeks.
Registry description
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.

Secondary outcomes(3)

Objective Response Rate (ORR)
Time frame · After CAR-NK cells infusion, up to 52 weeks.
Registry description
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.
Disease control rate (DCR)
Time frame · up to 52 weeks.
Registry description
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.
Duration of response (DOR)
Time frame · up to 36 months
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedLi J, Hu H, Lian H, Yang S, Liu M, He J, Cao B, Chen D, Hu Y, Zhi C, Shen Y, Ye X, He B, Zhao M, Fan W, Xu L, Leidner R, Wu Q, Yang L, Zhang Z. NK-92MI Cells Engineered with Anti-claudin-6 Chimeric Antigen Receptors in Immunotherapy for Ovarian Cancer. Int J Biol Sci. 2024 Feb 11;20(5):1578-1601. doi: 10.7150/ijbs.88539. eCollection 2024. PMID 38481806

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. patients with advanced ovarian cancer or other cancers with expression of claudin6. 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: 1. Had accepted gene therapy before; 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. -

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