A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor
NCT ID: NCT06954558
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2025-03-18
2028-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GK01 injection
Autologous tumor-reactive T cells injection
GK01 Injection
Autologous tumor-reactive T cells injection
Interventions
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GK01 Injection
Autologous tumor-reactive T cells injection
Eligibility Criteria
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Inclusion Criteria
2. At the date of signing ICF, 18 \~70 years old, male or female；
3. Histopathological confirmed advanced solid tumor patients who have failed to standard treatment or intolerance with standard treatment；
4. There is at least one resectable tumor lesion that has not received radiation therapy or other local therapies;
5. At least one measurable lesion at baseline per RECIST version 1.1；
6. The expected survival time is more than 12 weeks;
7. ECOG 0-1 points;
8. Adequate organ functions
18 Years
70 Years
ALL
No
Sponsors
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Beijing Geek Gene Technology Co., LTD
UNKNOWN
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Locations
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GK01IIT-TZ01
Identifier Type: -
Identifier Source: org_study_id
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