GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Sponsor: Grit Biotechnology
A observational or N/A phase clinical study on Solid Tumors, Adult, this trial is actively recruiting participants. The trial is conducted by Grit Biotechnology and has accumulated 7 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Status Flow
Change History
7 versions recorded-
Apr 16, 2026 — Present [daily]
Recruiting
Phase: PHASE1 → None
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Mar 2025 — Apr 2026 [monthly]
Recruiting PHASE1
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Sep 2024 — Mar 2025 [monthly]
Recruiting PHASE1
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE1
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Nov 2023 — Jul 2024 [monthly]
Recruiting PHASE1
▶ Show 2 earlier versions
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May 2023 — Nov 2023 [monthly]
Recruiting PHASE1
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Jul 2022 — May 2023 [monthly]
Recruiting PHASE1
First recorded
May 2022
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period. The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes： 1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine). 2. GT101 infusion. 3. post-infusion treatment (interleukin-2 intravenous push).
Contact Information
- Grit Biotechnology
For direct contact, visit the study record on ClinicalTrials.gov .