CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 44 target
Drug / intervention
HS-IT101 Injectiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06342336
NCT06342336Phase 1RecruitingMonitorUpdated 26mo ago · Completion was 3mo ago
Slow Enrollment
Monitor
CompareCT.gov

Single Arm, Phase I Clinical Study of HS-IT101 Injection in the Treatment of Advanced Solid Tumors

Qingdao Sino-Cell Biomedicine Co., Ltd.·interventional·Posted Apr 2, 2024·Updated Apr 2, 2024

In Brief

A Phase 1 clinical trial evaluating HS-IT101 Injection for Solid Tumor. Currently recruiting, targeting 44 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed Summary

Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesChina
CollaboratorsCancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Hospital of Jilin University, West China Hospital

Timeline

Phase 1Recruiting
20242025202620272028
First PostedApr 2, 2024
Enrollment StartJan 18, 2024
Primary CompletionMar 31, 2026
Study CompletionMar 31, 2028
TodayJul 1, 2026
Enrollment to primary: 2.2 yearsPosted 2.2 years ago

Interventions

HS-IT101 Injectiondrug

Adoptive transfer of 5x10\^9-6x10\^10 autologous TIL to patients i.v. in 30-60 minutes.