A Clinical Study of GK02 in Malignant Ascites

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

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

Treatments tested in this trial

  • GK02

Treatment groups

9 Participants
are divided into 1 treatment group

Sponsors and collaborators

Beijing Geekgene Technology Co., LTD

Lead sponsor

Beijing GoBroad Hospital

Collaborator