Study ICT-GCC19CART-US-001 (CARAPIA-1) is a Phase 1 study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of GCC19CART in subjects with relapsed or refractory metastatic colorectal cancer.

Start Date01 Aug 2022

Sponsor / Collaborator

Innovative Cellular Therapeutics, Inc.

100 Clinical Results associated with ICTCAR CRC(Innovative Cellular Therapeutics)

100 Translational Medicine associated with ICTCAR CRC(Innovative Cellular Therapeutics)

100 Patents (Medical) associated with ICTCAR CRC(Innovative Cellular Therapeutics)

Literatures (Medical) associated with ICTCAR CRC(Innovative Cellular Therapeutics)

01 Oct 2023·Lung

Targeting CDH17 with Chimeric Antigen Receptor-Redirected T Cells in Small Cell Lung Cancer.

Article

Author: Wang, Wenzhong ; Zhao, Jinhui ; Tian, Wen

BACKGROUND:

Chimeric antigen receptor T cell (CAR-T) therapy stands as a precise and targeted approach in the treatment of malignancies. In this study, we investigated the feasibility of targeting Cadherin 17 (CDH17) with CDH17 CAR-T cells as a therapeutic modality for small cell lung cancer (SCLC).

METHODS:

CDH17 expression levels were assessed in human SCLC tumor tissues and cell lines using qPCR and Western blot. Subsequently, we established CDH17 CAR-T cells and assessed their cytotoxicity by co-culturing them with various SCLC cell lines at different effector-to-target (E:T) ratios, complemented by ELISA assays. To ascertain the specificity of CDH17 CAR-T cells, we conducted experiments on SCLC cells with and without CDH17 expression (shRNAs). Furthermore, we employed an SCLC xenograft model to evaluate the in vivo efficacy of CDH17 CAR-T cells.

RESULTS:

Our results revealed a significant upregulation of CDH17 in both SCLC tissues and cell lines. CDH17 CAR-T cells exhibited robust cytotoxic activity against SCLC cells in vitro, while demonstrating no cytotoxicity towards CDH17-deficient SCLC cells and HEK293 cells that lack CDH17 expression. Importantly, the production of IFN-γ and TNF-α by CDH17 CAR-T cells correlated with their cytotoxic potency. Additionally, treatment with CDH17 CAR-T cells significantly decelerated the growth rate of SCLC-derived xenograft tumors in vivo. Remarkably, no significant difference in body weight was observed between the control group and the group treated with CDH17 CAR-T cells.

CONCLUSIONS:

The preclinical data open further venues for the clinical use of CDH17 CAR-T cells as an immunotherapeutic strategy for SCLC treatment.

01 Sep 2023·EClinicalMedicine

RUNX-3-expressing CAR T cells targeting glypican-3 in patients with heavily pretreated advanced hepatocellular carcinoma: a phase I trial

Article

Author: Gao, Wanwan ; Zhai, You ; Bao, Xuanwen ; Liu, Lulu ; Liu, Zhen ; Zhao, Qingwei ; Zhao, Peng ; Lin, Meihua ; Zhang, Hangyu ; Tong, Zhou ; Fang, Weijia ; Liang, Tingbo ; Yuan, Daijing ; Fu, Qihan ; Dai, Xiaomeng ; Li, Zonghai ; Wang, Huamao ; Wang, Yumeng ; Zheng, Yi ; Zhu, Xudong

Background:

Glypican-3 (GPC3) is a well-characterized hepatocellular carcinoma (HCC)-associated antigen and a promising target for HCC treatment. CT017 CAR T cells were engineered to co-express CAR-GPC3 and runt-related transcription factor 3 (RUNX3), which triggers CD8⁺ T-cell infiltration into the cancer microenvironment.

Methods:

This single-center, single-arm, open-label, phase I clinical study enrolled heavily pretreated patients with GPC3-positive HCC between August 2019 and December 2020 (NCT03980288). Patients were treated with CT017 CAR T cells at a dose of 250 × 10⁶ cells. The primary objective was to assess the safety and tolerability of this first-in-human product.

Findings:

Six patients received 7 infusions (one patient received 2 infusions) at the 250 × 10⁶ cells dose. Three patients received CT017 monotherapy, and three patients received CT017-tyrosine kinase inhibitor (TKI) combination therapy at the first infusion. One patient received CT017-TKI combination therapy at the second infusion after CT017 monotherapy. All patients experienced cytokine release syndrome (CRS), with 50% (3/6) at Grade 2, 50% (3/6) at Grade 3, and all events resolved after treatment. No immune effector cell-associated neurotoxicity syndrome was observed. Dose escalation was not performed due to the investigator's decision regarding safety. Of six evaluable patients, one achieved partial response and two had stable disease for a 16.7% objective response rate, 50% disease control rate, 3.5-month median progression-free survival, 3.2-month median duration of disease control, and 7.9-month median overall survival (OS) with 7.87-month median follow-up. The longest OS was 18.2 months after CT017 infusion.

Interpretation:

Current preliminary phase I data showed a manageable safety profile and promising antitumor activities of CT017 for patients with advanced HCC. These results need to be confirmed in a robust clinical trial.

Funding:

This study was funded by CARsgen Therapeutics Co., Ltd.

01 Apr 2023·Cancer immunology, immunotherapy : CII

Targeting FLT3-specific chimeric antigen receptor T cells for acute lymphoblastic leukemia with KMT2A rearrangement

Article

Author: Sugita, Kanji ; Yagyu, Shigeki ; Iehara, Tomoko ; Imamura, Toshihiko ; Yoshida, Hideki ; Suematsu, Masaya ; Nakazawa, Yozo ; Osone, Shinya

CD19-specific chimeric antigen receptor T (CAR T) immunotherapy is used to treat B-cell malignancies. However, antigen-escape mediated relapse following CAR T therapy has emerged as a major concern. In some relapsed cases, especially KMT2A rearrangement-positive B-acute lymphoblastic leukemia (KMT2A-r B-ALL), most of the B-cell antigens are lost via lineage conversion to the myeloid phenotype, rendering multi-B-cell-antigen-targeted CAR T cell therapy ineffective. Fms-related tyrosine kinase-3 (FLT3) is highly expressed in KMT2A-r B-ALL; therefore, in this study, we aimed to evaluate the antitumor efficacy of CAR T cells targeting both CD19 and FLT3 in KMT2A-r B-ALL cells. We developed piggyBac transposon-mediated CAR T cells targeting CD19, FLT3, or both (dual) and generated CD19-negative KMT2A-r B-ALL models through CRISPR-induced CD19 gene-knockout (KO). FLT3 CAR T cells showed antitumor efficacy against CD19-KO KMT2A-r B-ALL cells both in vitro and in vivo; dual-targeted CAR T cells showed cytotoxicity against wild-type (WT) and CD19-KO KMT2A-r B-ALL cells, whereas CD19 CAR T cells demonstrated cytotoxicity only against WT KMT2A-r B-ALL cells in vitro. Therefore, targeting FLT3-specific CAR T cells would be a promising strategy for KMT2A-r B-ALL cells even with CD19-negative relapsed cases.

News (Medical) associated with ICTCAR CRC(Innovative Cellular Therapeutics)

31 Oct 2023

·www.globenewswire.com

Innovative Cellular Therapeutics (ICT) Presented Updated Data of the China-IRB Study of GCC19CART in Metastatic Colorectal Cancer at European Society for Medical Oncology (ESMO) Congress 2023

ROCKVILLE, Md., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced the Company presented at European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain from October 20th to 24th. ICT presented updated data from its China-IRB study of GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in a poster presentation. Presentation details were as follows: A Phase 1 Dose Escalation Study of GCC19CART a Novel CoupledCAR® Therapy for Subjects with Metastatic Colorectal CancerAbstract: 4936Session Title: Colorectal cancer Date and Time: Sunday, October 22nd, 2023 at 12:00 to 13:00 CESTPresenter: Lucy Lu, MD, Chief Operations Officer of ICT This presentation highlights updated survival data from the 21 subjects who were enrolled in two dose escalation groups in IRB-approved studies in China. Of the 21 subjects who were enrolled on or before Dec 13, 2021, 13 subjects have been enrolled to dose level 1 (1x106 cells/kg) and 8 subjects have been enrolled to dose level 2 (2x106 cells/kg). The combined objective response rate (ORR) per RECIST 1.1 for both dose levels was 28.6% (6/21). For dose level 1, the ORR was 15.4% (2/13). For dose level 2, the ORR was 50% (4/8) and the rest of the 4 subjects had a best overall response of SD for a disease control rate (DCR) of 100% out to three months. The most common adverse events were cytokine release syndrome (CRS) in 20/21 subjects (Grade 1 19/21 (90.4%) or Grade 3 1/21 (4.8%)) and diarrhea in 20/21 subjects (Grade 1 6/21 (28.6%) Grade 2 5/21 (23.8%) Grade 3 9/21 (42.9%)). Neurotoxicity was observed in 2/21 (9.5%) subjects with one Grade 3 and one Grade 4 and resolved with corticosteroids. The median overall survival (OS) is approximately 13 months for patients in dose level 1. The median OS is approximately 24 months in dose level 2 with 4 of the 8 patients still alive. The Company’s Phase 1 study of GCC19CART is enrolling patients with R/R mCRC at multiple sites in the U.S. About Innovative Cellular Therapeutics Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company headquartered in Rockville, MD. ICT is focused on the development of cellular immunotherapies for the treatment of solid tumors. ICT’s unique CoupledCAR® technology platform is designed to overcome the common challenges of treating solid tumors. ICT has achieved promising preclinical and proof-of-concept clinical results in late-stage solid tumors, such as colorectal cancer and prostate cancer. The Company has a broad pipeline of CAR-T candidates targeting additional solid tumors. For more information, please visit www.ictbio.com. Investor Relations Contacts: Innovative Cellular Therapeutics:ir@ictbioinc.com

Phase 1Cell TherapyImmunotherapyClinical ResultASCO

24 May 2023

·www.globenewswire.com

Innovative Cellular Therapeutics (ICT) Presented Data at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting

ROCKVILLE, Md., May 24, 2023 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced the Company presented at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual meeting in Los Angeles, California. May 16-20, 2023. ICT presented GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in an oral presentation. Details for the oral presentation are as follows: A phase 1 dose escalation study of GCC19CART - a novel CoupledCAR therapy for subjects with metastatic colorectal cancerSession Type: Oral AbstractSession Title: Gene and Cell Therapy Trials in ProgressPresenter: Victor Lu, Ph.D, Chief Technology Officer, ICTDate and Time: May 20th, 2023, at 2:45 pm – 3:00 pm ET This presentation highlights data from the 21 patients who were enrolled in two dose escalation groups at 5 hospitals in China. Patients were followed for safety and preliminary evidence of efficacy. Thirteen patients were enrolled in dose level 1 (1x106 cells/kg) and 8 patients were enrolled in dose level 2 (2x106 cells/kg). For dose level 1, the objective response rate (ORR) per RECIST 1.1 was 15% (2/13). For dose level 2, The ORR per RECIST 1.1 was 50% (4/8). Median follow-up has exceeded 20 months. The most common adverse events were cytokine release syndrome (CRS) and diarrhea. Neurotoxicity was observed in 2 patients that was resolved with corticosteroids. Overall, GCC19CART demonstrated meaningful dose dependent clinical activity and an acceptable safety profile in patients with R/R mCRC. GCC19CART is now in clinical development in the U.S. and is on track to complete Phase 1 dose escalation clinical trial this year. About Innovative Cellular Therapeutics Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company headquartered in Rockville, MD. ICT is focused on the development of cellular immunotherapies for the treatment of solid tumors. ICT’s unique CoupledCAR® technology platform is designed to overcome the common challenges of treating solid tumors. ICT has achieved promising preclinical and proof-of-concept clinical results in late-stage solid tumors, such as colorectal cancer and prostate cancer. The Company has a broad pipeline of CAR-T candidates targeting additional solid tumors. For more information, please visit www.ictbio.com. Investor Relations Contacts:Innovative Cellular Therapeutics:ir@ictbioinc.com

Phase 1ImmunotherapyCell TherapyASCOAACR

02 May 2023

·www.biospace.com

Innovative Cellular Therapeutics (ICT) Presented Updated Data at the American Association for Cancer Research (AACR) Annual Meeting

ROCKVILLE, Md., May 02, 2023 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics, Inc. (ICT), a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies for solid tumors, today announced the Company presented at the Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida April 14-19, 2023. ICT presented GCC19CART, its lead product candidate from the Company’s CoupledCAR® technology, being developed to treat patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) in an oral presentation. Details for the oral presentation are as follows: A phase 1 dose escalation study of GCC19CART - a novel CoupledCAR therapy for subjects with metastatic colorectal cancer Session Type: Minisymposium Session Title: Immunotherapy Presenter: Victor Lu, Ph.D, Chief Technology Officer, ICT Date and Time: April 16th, 2023 at 3:00 pm – 5:00 pm ET This presentation highlights data from the 21 patients who were enrolled in two dose escalation groups at 5 hospitals in China. Patients were followed for safety and preliminary evidence of efficacy. Thirteen patients were enrolled in dose level 1 (1x106 cells/kg) and 8 patients were enrolled in dose level 2 (2x106 cells/kg). For dose level 1, the objective response rate (ORR) per RECIST 1.1 was 15% (2/13). For dose level 2, The ORR per RECIST 1.1 was 50% (4/8). Median follow-up has exceeded 20 months. The most common adverse events were cytokine release syndrome (CRS) and diarrhea. Neurotoxicity was observed in 2 patients that was resolved with corticosteroids. Overall, GCC19CART demonstrated meaningful dose dependent clinical activity and an acceptable safety pro patients with R/R mCRC. GCC19CART is now in clinical development in the U.S. and is on track to complete Phase 1 dose escalation clinical trial this year. About Innovative Cellular Therapeutics Innovative Cellular Therapeutics (ICT) is a private clinical stage biotechnology company headquartered in Rockville, MD. ICT is focused on the development of cellular immunotherapies for the treatment of solid tumors. ICT’s unique CoupledCAR® technology platform is designed to overcome the common challenges of treating solid tumors. ICT has achieved promising preclinical and proof-of-concept clinical results in late-stage solid tumors, such as colorectal cancer and thyroid cancer. The Company has a broad pipeline of CAR-T candidates targeting additional solid tumors. For more information, please visit Investor Relations Contacts: Innovative Cellular Therapeutics: ir@ictbioinc.com

Phase 1ImmunotherapyAACRCell TherapyClinical Result

100 Deals associated with ICTCAR CRC(Innovative Cellular Therapeutics)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Cancer	Phase 1	US	Innovative Cellular Therapeutics Co., Ltd.	01 Aug 2022
Metastatic Colorectal Carcinoma	Phase 1	US	Innovative Cellular Therapeutics, Inc.	01 Aug 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05319314 (CARAPIA-1, ASGCT2024) Manual	Phase 1	Metastatic Colorectal Carcinoma	4	GCC19CART	hyuykdwtak(uwjeeomyxa) = frtkvonwyi glpummzzll (slhmmjygoj ) View more	Positive	08 Apr 2024
ESMO2023 Manual	Phase 1	Colorectal Cancer	21	GCC19CART	lyztlquyqm(sferzccsxl) = The most common adverse events were cytokine release syndrome (CRS) in 21/21 subjects (Grade 1 19/21 (90.48%) or Grade 2 2/21 (9.52%)) and diarrhea in 21/21 subjects (Grade 1 6/21 (28.57%) Grade 2 5/21 (23.81%) Grade 3 9/21 (42.86%) or Grade 4 1/21 (4.76%)). uwaaxomuay (lhzwtsvuge )	Positive	22 Oct 2023
				GCC19CART
ChiCTR2000040645 (ASCO2023) Manual	Phase 1	Metastatic Colorectal Carcinoma	21	GCC19CART	jabpuztzok(eidzgluoaw) = wnkrqlaxkl eqmwouvaxo (oqitibehmi ) View more	Positive	31 May 2023
				dose level 1 (1x106 cells/kg)	qxhlkolpny(dbfxcgrdws) = whjmjdjift vpnfhqyiit (lezesclwoo ) View more
AACR2023	Phase 1	Metastatic Colorectal Carcinoma	21	GCC19CART 1 × 10^6 cells/kg	zetfbaxdfc(wenmszcebt) = Grade 1 19/21 (90.48%) or Grade 2 2/21 (9.52%) lijhcylyzf (btmevdntpj ) View more	-	04 Apr 2023
				GCC19CART 2 × 10^6 cells/kg

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