Delving into the Latest Updates on Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics) with Synapse

Overview

Basic Info

Drug Type

TIL therapy

Synonyms

TILS Shanghai Gencells Therapeutics, Tumor infiltrating lymphocytes Shanghai Gencells Therapeutics

Target-

Action-

Mechanism

Immunologic cytotoxicity, T lymphocyte replacements

Therapeutic Areas

NeoplasmsUrogenital DiseasesNervous System Diseases+ [2]

Active Indication

Female Genital NeoplasmsAdvanced breast cancerLiver Cancer+ [3]

Inactive Indication

Gastrointestinal Stromal TumorsGlioma

Originator Organization

Shanghai Gencells Therapeutics Co., Ltd.

Active Organization

Shanghai Gencells Therapeutics Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Start Date10 Dec 2021

Sponsor / Collaborator

Shanghai Gencells Therapeutics Co., Ltd.

[+1]

NCT05142475

/ RecruitingEarly Phase 1

A Clinical Study on TIL for the Treatment of Advanced Breast Cancer

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy (GC 101 TIL) in patients with advanced breast cancer. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Start Date19 Nov 2021

Sponsor / Collaborator

Shanghai Gencells Therapeutics Co., Ltd.

[+1]

NCT05098184

/ RecruitingEarly Phase 1

A Clinical Study on TIL for the Treatment of Advanced Melanoma

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Start Date26 Sep 2021

Sponsor / Collaborator

Shanghai Gencells Therapeutics Co., Ltd.

[+1]

100 Clinical Results associated with Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics)

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100 Translational Medicine associated with Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics)

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100 Patents (Medical) associated with Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics)

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1

Literatures (Medical) associated with Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics)

BMC Medicine

IL-2-free tumor-infiltrating lymphocyte therapy with PD-1 blockade demonstrates potent efficacy in advanced gynecologic cancer

Article

Author: Liu, Chunhong ; Li, Caixia ; Yang, Weihong ; Lu, Zhen ; Wang, Rui ; Zhu, Jihui ; Guo, Jing ; Wang, Chunyan ; Ge, Yao ; Cheng, Zhongping ; Bast, Robert C ; Ding, Jinye ; Jin, Huajun ; Chen, Rong ; Zhao, Binghui ; Luo, Ning ; Ai, Guihai ; Huang, Wei ; Liu, Shupeng ; Wu, Yuliang ; Shi, Weihui

AbstractBackgroundTumor-infiltrating lymphocyte (TIL) therapy has been restricted by intensive lymphodepletion and high-dose intravenous interleukin-2 (IL-2) administration. To address these limitations, we conducted preclinical and clinical studies to evaluate the safety, antitumor activity, and pharmacokinetics of an innovative modified regimen in patients with advanced gynecologic cancer.MethodsPatient-derived xenografts (PDX) were established from a local recurrent cervical cancer patient. TILs were expanded ex vivo from minced tumors without feeder cells in the modified TIL therapy regimen. Patients underwent low-dose cyclophosphamide lymphodepletion followed by TIL infusion without intravenous IL-2. The primary endpoint was safety; the secondary endpoints included objective response rate, duration of response, and T cell persistence.ResultsIn matched patient-derived xenografts (PDX) models, homologous TILs efficiently reduced tumor size (p < 0.0001) and underwent IL-2 absence in vivo. In the clinical section, all enrolled patients received TIL infusion using a modified TIL therapy regimen successfully with a manageable safety profile. Five (36%, 95% CI 16.3–61.2) out of 14 evaluable patients experienced objective responses, and three complete responses were ongoing at 19.5, 15.4, and 5.2 months, respectively. Responders had longer overall survival (OS) than non-responders (p = 0.036). Infused TILs showed continuous proliferation and long-term persistence in all patients and showed greater proliferation in responders which was indicated by the Morisita overlap index (MOI) of TCR clonotypes between infused TILs and peripheral T cells on day 14 (p = 0.004) and day 30 (p = 0.004). Higher alteration of the CD8+/CD4+ ratio on day 14 indicated a longer OS (p = 0.010).ConclusionsOur modified TIL therapy regimen demonstrated manageable safety, and TILs could survive and proliferate without IL-2 intravenous administration, showing potent efficacy in patients with advanced gynecologic cancer.Trial registrationNCT04766320, Jan 04, 2021.

100 Deals associated with Autologous tumour infiltrating lymphocytes (Shanghai Gencells Therapeutics)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 1	China	Shanghai Gencells Therapeutics Co., Ltd.	19 Nov 2021
Liver Cancer	Phase 1	China	Shanghai Gencells Therapeutics Co., Ltd.	26 Sep 2021
Melanoma	Phase 1	China	Shanghai Gencells Therapeutics Co., Ltd.	26 Sep 2021
Gastrointestinal Stromal Tumors	Phase 1	China	Shanghai Gencells Therapeutics Co., Ltd.	27 Jun 2021
Malignant glioma of brain	Phase 1	China	Shanghai Gencells Therapeutics Co., Ltd.	06 May 2021
Advanced Malignant Solid Neoplasm	Phase 1	China	Shanghai Gencells Therapeutics Co., Ltd.	22 Apr 2021
Glioma	Phase 1	China	Shanghai Gencells Therapeutics Co., Ltd.	14 Apr 2021
Female Genital Neoplasms	Phase 1	China	Shanghai Gencells Therapeutics Co., Ltd.	04 Jan 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04766320 (Pubmed) Manual	Phase 1	Female Genital Neoplasms	14	TIL infusion with modified regimen	(psvimibuff) = In the clinical section, all enrolled patients received TIL infusion using a modified TIL therapy regimen successfully with a manageable safety profile. ibsuufrxgi (eizriwzmmr ) View more	Positive	20 May 2024
SITC2017	Not Applicable	Melanoma	-	Tumor Infiltrating Lymphocytes (TIL) (Polystyrene 24-well culture plates)	vfmmzqlfjq(xdqqttlkyy) = wemnvmaezr xpfsyiviqf (uijjynitvp, 14) View more	Positive	07 Nov 2017
SITC2017	Not Applicable	Melanoma	-	Tumor Infiltrating Lymphocytes (TIL) (Gas-permeable (G-REX) 24-well culture plates)	vfmmzqlfjq(xdqqttlkyy) = mchybjllce xpfsyiviqf (uijjynitvp, 8) View more	Positive	07 Nov 2017