Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors

Grit Biotechnology

Status and phase: Enrolling; Early Phase 1

Conditions: Adult Gynecological Tumors

Treatments: Biological: Autologous tumor infiltrating lymphocyte injection（GT201）

Study type: Interventional

Funder types: Industry

Identifiers

NCT06834542

GRIT-CD-MED-CHN-002

Details and patient eligibility

About

This study is an early exploration clinical study with one arm. The study consists of two stages, namely the dose escalation stage and the dose extension stage:

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
2. The physical fitness status score of the ECOG is 0 or 1
3. At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion criteria

1. The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone);
2. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
3. Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;
4. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
5. Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

GT307 injection treatment group

Experimental group

Treatment:

Biological: Autologous tumor infiltrating lymphocyte injection（GT201）