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Trial Title:
GT201 Injection For The Treatment Of Advanced Solid Tumors
NCT ID:
NCT06144671
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GT201
Description:
Autologous tumor infiltrating lymphocyte injection
Arm group label:
GT201 treatment group
Summary:
Expected to complete 7 to 18 evaluable subjects (patients with advanced solid tumors)，3
dose groups.A modified "3+3" dose-escalation design is utilized,This includes both
accelerated dose escalation and traditional "3+3" dose escalation.The first dose group is
accelerated titration,The first dose group is an accelerated titration of 1 to 6
evaluable subjects;The second and third dose groups are based on the traditional "3+3"
dose-escalation principle,The second and third dose groups are based on the traditional
"3+3" dose-escalation principle, with 3 to 6 evaluable subjects enrolled respectively.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. The Patients (or legally authorized representative) 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.Must have a confirmed diagnosis of malignancy of their receptive histologies or
cytologies;
- 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 ≥1.0cm^3 (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 3 months prior to enrollment, such as:
cerebrovascular accident, deep vein thrombosis and pulmonary embolism
occurring;
-
3. Patients who have refractory or intractable epilepsy, poorly controlled
hydrothorax, hydrops abdominis, pericardial effusion or IL-2 contraindications;
-
4. Participate in other clinical trials within 4 weeks prior to the first dose of
this study, or planning to participate in this study and other clinical trials
at the same;
-
5. Patients who have received allogeneic bone marrow transplantation or an organ
allograft;
- 6.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).
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The fifth medical center of the General Hospital of the Chinese people's Liberation Army
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Haifeng Qing
Phone:
+86 13601365243
Email:
hifo@263.net
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University Of Science And Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaorong Dong, PHD
Phone:
+86 13986252286
Email:
xhzzdxr@126.com
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuping Sun, PHD
Phone:
+86 13370582181
Email:
13370582181@163.com
Facility:
Name:
West China Hospital Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongsheng Wang, PHD
Phone:
+86 18980602258
Email:
wangys@wchscu.cn
Start date:
September 13, 2023
Completion date:
September 13, 2026
Lead sponsor:
Agency:
Grit Biotechnology
Agency class:
Industry
Source:
Grit Biotechnology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06144671
