A Clinical Study of GK02 in Malignant Ascites

ConditionMalignant Ascites Caused by Advanced Solid Tumors

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorBeijing Geekgene Technology Co., LTD

About this trial

A single-arm, single-center, open-label clinical study comprising three cohorts, evaluating the safety, preliminary efficacy, and pharmacokinetic/ pharmacodynamic (PK/PD) characteristics of autologous tumor-reactive T cells (GK02) derived from malignant ascites caused by advanced solid tumors.

The trial initially plans to enroll 9 subjects with malignant ascites caused by advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and sign a written informed consent document；

At the date of signing ICF, 18 ~75 years old, male or female；

Patients with advanced solid tumors confirmed by histology or pathology to have failed at least second-line treatment (treatment failure is defined as progression after treatment or intolerance after treatment), including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, ovarian cancer, etc.；

Pathological diagnosis or clinical diagnosis of malignant ascites, and the researcher determines that treatment for malignant ascites is necessary; During screening, the ascites volume was confirmed to be above the medium level by ultrasound (the maximum depth of ascites in the supine position was ≥3.0cm, and the total volume was ≥500ml);

Disqualifiers

Those with a history of severe allergies or allergic reactions to any components of the drugs to be used in this study, including but not limited to NMA-LD drugs, contrast agents and contrast agents used in imaging examinations, excipients such as dimethyl sulfoxide (DMSO) and antibiotics in cell products;

Central nervous system (CNS) metastasis is present;

Toxicity from previous antitumor therapy did not return to grade 1 or baseline levels (CTCAE version 5.0);

Accompanied or prior to interstitial lung disease or interstitial pneumonia;

Trial design

Design model

Single group

Treatments tested in this trial

GK02
Drug
Autologous tumor-reactive T cells

Treatment groups

9 Participants

are divided into 1 treatment group

Group A: Tumor-reactive T cells-GK02Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of AEs

Incidence and severity of AEs, including but not limited to vital signs, physical examination, laboratory tests. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.

Time frame

12 months

Incidence of DLTs

Number of DLTs (dose limiting toxicities) during the first 28 days after the administrations of GK02 in each cohort.

Time frame

28 days

Secondary outcomes

Changes in the volume of malignant ascites

Change in malignant ascites volume at 28D（day）、2、3、4、5、6、9、12M（month） after GK02 treatment compared to baseline (prior to GK02 infusion).

Time frame

12 months

PuFS

From the first infusion of GK02 to the first paracentesis for ascites drainage or death from any cause.

Time frame

12 months

OS will be assessed from the first GK02 infusion to death from any cause.

Time frame

12 months

Other outcomes

Count of TCR copies

T-cell receptor sequencing (TCR-seq) by obtaining the copy number of the target GK02 T-cell receptors (TCRs) in peripheral blood and malignant ascites： Cmax、Tmax、AUC0-t、AUC0-inf、λz、T1/2.

Time frame

12 months

Concentration of Cytokines

IL-1β、IL-2、IL-4、IL-6、IL-8、IL-10、 IL-12、TGF-b1、IFN-γ and TNF-α

Time frame

12 months

Percentage of Lymphocyte subsets

Total T cells、Th/Ti cells、Ts/Tc cells、NK cells

Time frame

12 months

Proportion of EpCAM + cells

Proportion of EpCAM+ cells among cells

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Geekgene Technology Co., LTD

Lead sponsor

Beijing GoBroad Hospital

Collaborator

Source ClinicalTrials.gov

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