UnknownPhase 1

Single Arm Phase I Trail of Autologous Tumor Infiltrating Lymphocyte Injection (GT202) in the Treatment of Metastatic or Recurrent Gynecological Tumors

China36 participantsStarted 2022-03

Plain-language summary

A prospective, open-label, non-randomized, Phase 1 study evaluating autologous tumor infiltrating lymphocyte injection (GT202) in the treatment of metastatic or recurrent Gynecological tumors.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

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Inclusion criteria

✓. hematologic parameters: Absolute neutrophil count (ANC) ≥ 1.5×109/L Lymphocyte counts（LC）\>0.5×109/L Platelet ≥100×109/L Hemoglobin (Hb) ≥ 90g/L
✓. AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN), TBIL (total bilirubin)≤1.5×ULN, except following:

What they're measuring

Types and incidence of Dose-limiting toxicity (DLT)

Timeframe: up to 28 days after GT202 infusion

Types and incidence of adverse events (AEs) ，serious adverse events (SAEs) and adverse events of special interest (AESI)

Timeframe: Up to 2 years after GT202 infusion

Maximum tolerated dose

Timeframe: up to 28 days after GT202 infusion

Trial details

NCT IDNCT05238818

SponsorXinWu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01

Contact for this trial

xin wu, PHD

(021)33189900-6529 wuxin_fc@fudan.edu.cn

View on ClinicalTrials.gov More Metastatic or Recurrent Gynecological Tumors trials