Delving into the Latest Updates on HS-IT101 with Synapse

Overview

Basic Info

Drug Type

TIL therapy

Synonyms

HS IT101, HSIT101

Target-

Action-

Mechanism

Immunologic cytotoxicity, T lymphocyte replacements

Therapeutic Areas

NeoplasmsRespiratory DiseasesSkin and Musculoskeletal Diseases+ [1]

Active Indication

Locally Advanced MelanomaAdvanced Malignant Solid NeoplasmHead and Neck Neoplasms+ [4]

Inactive Indication-

Originator Organization

Qingdao Sino-cell Biomedicine Co., Ltd.

Active Organization

Qingdao Sino-cell Biomedicine Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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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 melanoma.

Start Date10 Jun 2025

Sponsor / Collaborator

Qingdao Sino-cell Biomedicine Co., Ltd.

NCT06342336

/ RecruitingPhase 1

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

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.

Start Date18 Jan 2024

Sponsor / Collaborator

Qingdao Sino-cell Biomedicine Co., Ltd.

[+3]

NCT05539768

/ Not yet recruitingEarly Phase 1IIT

Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes (HS-IT101) for the Treatment of Advanced Solid Tumor

Prospective, single-center, 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.

Start Date08 Oct 2022

Sponsor / Collaborator

The Affiliated Hospital of Qingdao University

[+1]

100 Clinical Results associated with HS-IT101

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100 Translational Medicine associated with HS-IT101

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100 Patents (Medical) associated with HS-IT101

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100 Deals associated with HS-IT101

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Melanoma	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	10 Jun 2025
Advanced Malignant Solid Neoplasm	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	13 Dec 2023
Advanced breast cancer	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	08 Oct 2022
Head and Neck Neoplasms	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	-
Non-Small Cell Lung Cancer	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	-
Uterine Cervical Cancer	IND Approval	China	Qingdao Sino-cell Biomedicine Co., Ltd.	30 Nov 2023
Soft Tissue Neoplasms	Preclinical	China	Qingdao Sino-cell Biomedicine Co., Ltd.	01 Dec 2024