The RETIRE Trial: A Randomized Phase 2 Trial of Adoptive Therapy With Treg Adoptive Cell Transfer (TRACT) To Prevent Rejection in Living Donor Kidney Transplant Recipients

The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients.
Enrolled subjects will be randomized to one of 2 study arms:
Arm 1 subjects will receive standard of care immunosuppression
Arm 2 subjects will receive initial standard of care (SOC) immunosuppression and a single infusion of TRK-001. Three months after the transplant, Arm 2 subjects may be able to begin reducing their immunosuppression medication to a 1-drug regimen.
The primary outcome measures of trial are to evaluate several components indicating immunologic problems with the transplanted organ at 1-year post-transplant and to evaluate the ability for the study subjects given TRK-001 to wean to a 1-drug immunosuppression regimen.
All enrolled subjects will be followed for 5 years post-transplant.

Start Date13 Jun 2025

Sponsor / Collaborator

Taiwan Bio Therapeutics Co., Ltd.

100 Clinical Results associated with TRK-001

100 Translational Medicine associated with TRK-001

100 Patents (Medical) associated with TRK-001

News (Medical) associated with TRK-001

28 Oct 2024

·www.prnewswire.com

Treg Cell-based Therapies Clinical Trial Pipeline Appears Robust With 51+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Treg Cell-based Therapies refer to therapeutic approaches that utilize regulatory T cells (Tregs) to modulate the immune system. Innovations in cell expansion and engineering techniques have greatly enhanced the ability to isolate, expand, and deliver functional Tregs. Ex vivo expansion technologies and genetic engineering (such as CAR-Tregs) have opened up new possibilities for enhancing the stability, specificity, and effectiveness of Treg therapies. LAS VEGAS, Oct. 28, 2024 /PRNewswire/ -- DelveInsight's ' Treg Cell-based Therapies Pipeline Insight 2024 ' report provides comprehensive global coverage of available, marketed, and pipeline Treg cell-based therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Treg cell-based therapies pipeline domain. Key Takeaways from the Treg Cell-based Therapies Pipeline Report DelveInsight's Treg cell-based therapies pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for various indications. Key Treg cell-based therapies companies such as Orca Bio, Nektar Therapeutics, Quell Therapeutics, Cugene, Sangamo Therapeutics, Abata Therapeutics, HCW Biologics, GentiBio, Tr1X, PolTREG, Cellenkos, VT BIO, Miltenyi Biotec GmbH, KSQ Therapeutics, TeraImmune, Tract Therapeutics, and others are evaluating new Treg cell-based therapies to improve the treatment landscape. Promising Treg cell-based therapies in the pipeline in various stages of development include Orca-T, NKTR-358, QEL-001, CUG-252, TX200, ABA-101, HCW9302, GNTI-122, TRX-103, PTG-020, CK-0804, VT-301, TR-004, KSQ 001, TI-620, TRK 001, and others. In October 2024, Quell Therapeutics hired eXmoor Pharma to make supplies of its pipeline of novel immunosuppressive cell therapies—called CAR-Tregs—at its new cell and gene therapy facility. Quell recently teamed with fellow U.K.-based eXmoor in a strategic partnership that will see the contractor make its candidate autoimmune disease cell therapies for early-phase clinical studies. In September 2024, Abata Therapeutics announced that ABA-101, an autologous regulatory T-cell (Treg) therapy for the treatment of patients with progressive multiple sclerosis (MS), has received fast-track designation from the US FDA. In September 2024, PolTREG S.A. announced that China's National Intellectual Property Administration, PRC (CNIPA) had issued a notification to grant a patent for the intrathecal administration of the company's cellular therapies in patients with multiple sclerosis (MS). The intrathecal administration is an established method used to deliver therapy across the blood-brain barrier via injection into the subarachnoid space. In June 2024, Orca Bio announced that it had completed enrollment in the pivotal Precision-T Phase III clinical study. The primary endpoint of the Precision-T study is the rate of survival free from moderate-to-severe chronic graft versus host disease (GvHD). In March 2024, PolTREG announced that the company is planning to launch Phase II trials testing its Tregs therapy — the T-cell-based treatment PTG-007 in people with multiple sclerosis (MS). In February 2024, Cellenkos announced encouraging safety data from its innovative CK0803 neurotrophic T regulatory (Treg) cell therapy, being developed to help treat individuals with Amyotrophic Lateral Sclerosis (ALS). The company was given the green light to move ahead following a review of safety data by the Data Safety Monitoring Board (DSMB). In August 2023, BlueRock Therapeutics LP, a wholly owned, independently operated subsidiary of Bayer AG, and bit.bio, the company coding human cells for novel cures announced a collaboration and option agreement for the discovery and manufacture of iPSC-derived regulatory T cells (Tregs) for use in creating therapeutics. Request a sample and discover the recent advances in Treg cell-based therapies @ Treg Cell-based Therapies Pipeline Outlook The Treg cell-based therapies pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Treg cell-based therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Treg cell-based therapies pipeline landscape. Treg Cell-based Therapies Overview Treg cell-based therapies represent a promising frontier in immunotherapy, focusing on harnessing regulatory T cells (Tregs) to modulate the immune response in various clinical settings. Tregs play a crucial role in maintaining immune homeostasis and preventing autoimmune reactions by suppressing excessive immune responses. In the context of autoimmune diseases, these therapies aim to restore balance by expanding or enhancing Tregs to dampen inappropriate immune activity. For instance, in diseases like type 1 diabetes or multiple sclerosis, Treg cell-based treatments seek to prevent or slow disease progression by reestablishing immune tolerance. Beyond autoimmune disorders, Treg cell-based therapies are also being explored in cancer treatment. Tumors often exploit Tregs to evade immune detection, and by manipulating these cells, it's possible to enhance the anti-tumor immune response. Strategies include expanding Tregs ex vivo and reinfusing them to boost their numbers or modifying them to more effectively target tumor-associated antigens. These approaches hold the potential to improve the efficacy of existing immunotherapies and offer new avenues for treating cancers that are currently resistant to conventional treatments. Find out more about Treg cell-based therapies @ Treg Cell-based Therapies in Development A snapshot of the Treg Cell-based Therapies Pipeline Drugs mentioned in the report: Learn more about the emerging Treg cell-based therapies @ Treg Cell-based Therapies Clinical Trials Treg Cell-based Therapies Therapeutics Assessment The Treg cell-based therapies pipeline report proffers an integral view of the emerging Treg cell-based therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Treg Cell-based Therapies Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intravenous, Subcutaneous, Oral, Intramuscular Therapeutics Assessment By Molecule Type: Monoclonal antibody, Small molecule, Peptide Therapeutics Assessment By Mechanism of Action: Immunologic cytotoxicity, T lymphocyte replacements, Interleukin 2 replacements, Cell replacements Key Treg Cell-based Therapies Companies: Orca Bio, Nektar Therapeutics, Quell Therapeutics, Cugene, Sangamo Therapeutics, Abata Therapeutics, HCW Biologics, GentiBio, Tr1X, PolTREG, Cellenkos, VT BIO, Miltenyi Biotec GmbH, KSQ Therapeutics, TeraImmune, Tract Therapeutics, and others. Key Treg Cell-based Therapies in Pipeline: Orca-T, NKTR-358, QEL-001, CUG-252, TX200, ABA-101, HCW9302, GNTI-122, TRX-103, PTG-020, CK-0804, VT-301, TR-004, KSQ 001, TI-620, TRK 001, and others. Dive deep into rich insights for Treg cell-based therapies assessment, visit @ Treg Cell-based Therapies Therapeutics Assessment Table of Contents For further information on the Treg cell-based therapies pipeline therapeutics, reach out @ Treg Cell-based Therapies Pipeline Landscape Related Reports Type 1 Diabetes Market Type 1 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 1 diabetes companies, including Histogen , Novo Nordisk, Prevention Bio, among others. 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LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyCell TherapyFast TrackPhase 3

06 Dec 2023

·www.biospace.com

Taiwan Bio and TRACT Therapeutics, Inc. Announce Strategic Partnership to Advance a Novel Therapeutic Approach for Preventing Rejection in Solid Organ Transplant

CHICAGO & TAIPEI, Taiwan--(BUSINESS WIRE)-- Taiwan Bio and TRACT Therapeutics are pleased to announce a new strategic partnership to advance a cellular therapy to revolutionize the prevention of allograft rejection in solid organ transplant. The partners will launch a multi-center Phase 2 clinical trial investigating the reduction of immunosuppressant drugs in living donor kidney transplant recipients in both the United States and Taiwan. This press release features multimedia. View the full release here: This partnership leverages Taiwan Bio’s world-class expertise in cellular therapy manufacturing and TRACT Therapeutics’ innovative immune modulating regulatory T cell therapy platform. By combining their strengths, the companies are set to explore new frontiers in enabling allogeneic tissue transplant with a focus on enhanced patient outcomes and improved quality of life. The upcoming Phase 2 trial builds upon the promising results from a Phase 1 study which demonstrated an excellent safety pro encouraging efficacy signals with TRACT’s autologous Treg product, TregCelTM. "We believe that this collaboration holds tremendous promise for patients seeking better therapeutic options," said Cyrus Yang, COO of Taiwan Bio. "Together with TRACT Therapeutics, we can bring a synergy of technology and experience to accelerate the development of transformational Treg therapies." John Flavin, CEO of Portal Innovations member company, TRACT Therapeutics, added, “Our collaboration with Taiwan Bio is a strategic milestone that paves the way for mutual success. TRACT recognizes the importance of a state-of-the art GMP cell manufacturing facility to advance the development of our Treg therapy and found the best-in-class capabilities of the Taiwan Bio manufacturing team aligns perfectly with our needs. By working with Taiwan Bio, we are bringing the best of both worlds together—manufacturing excellence and a cutting-edge, personalized cellular therapy for patients. Our Phase 2 trial represents a significant step forward in our mission to provide solid organ transplant patients with better treatment options." Joseph R Leventhal, MD, PhD, Fowler McCormick Professor of Surgery at Northwestern University and Scientific Founder of TRACT Therapeutics, stated, “There is a critical need to develop better treatments for patients undergoing a solid organ transplant. TRACT’s regulatory T cell therapy platform holds the promise to revolutionize our approach to organ transplantation by not only preventing organ rejection but also enabling us to reduce the reliance on toxic immunosuppressive drugs. By harnessing the power of regulatory T cells, we can provide our patients with the potential for long-term, rejection-free transplant success while minimizing the adverse effects associated with traditional immunosuppression.” Matthew Cooper, MD, Chief of Transplantation at the Medical College of Wisconsin added, “This therapy represents a potential pivotal shift in the field of transplantation, offering new hope for improved outcomes and enhanced quality of life for all patients receiving solid organ transplants." The Phase 2 clinical trial represents the first collaborative effort between the two companies, and further updates on the trial's progress will be shared in the coming months. About Taiwan Bio Taiwan Bio Therapeutics Co., Ltd. is a one-stop, total solution cell therapy CDMO focusing on accelerating the translation of early-stage cell therapies to clinical products. Its cell engineering and cGMP manufacturing technology platforms streamline “vein-to-vein” process design and allow thorough product characterization. Taiwan Bio is where cutting-edge science meets world-class manufacturing, helping innovators to convert their bench side discoveries into bed side therapies in record time. Discover more at: About TRACT Therapeutics TRACT Therapeutics, Inc. is a clinical stage biotechnology company developing a novel therapeutic approach to restoring immune balance in organ transplantation and autoimmune disease. Its proprietary platform technology, using autologous polyclonal expanded regulatory T cells, was developed at Northwestern University by pioneer, Joseph R Leventhal, MD, PhD, Fowler McCormick Professor of Surgery at Northwestern University, and his research colleagues. For additional information, visit our website at . This press release contains forward-looking statements that express the belief, potential anticipation, or expectation, as well as other statements which are not historical fact, and statements related to clinical trials and their results, design, FDA product approvals or other marketing approvals, features, functionality and performance. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements.

Cell TherapyPhase 2Phase 1ImmunotherapyClinical Result

100 Deals associated with TRK-001

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Renal transplant rejection	Phase 2	United States	-	13 Jun 2025
Renal transplant rejection	Phase 2	Taiwan Province	-	13 Jun 2025
Hepatitis, Autoimmune	Phase 1	United States	TRACT Therapeutics, Inc.	23 May 2020
Crohn Disease	Phase 1	United States	TRACT Therapeutics, Inc.	24 Apr 2020
Liver transplant rejection	Preclinical	United States	TRACT Therapeutics, Inc.	-

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