Reduced Intensity Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Sirolimus/Mycophenolate Mofetil/RGI-2001 Based GVHD Prevention: a Pilot Study

This research study is studying the RGI-2001 for preventing Graft-vs-Host Disease (GVHD) in people with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disorders (MPN), chronic myelomonocytic leukemic (CMML), chemosensitive hodgkin lymphoma (HL), or Non-Hodgkin lymphoma (NHL).who will have a blood stem cell transplantation.
GVHD is a condition in which cells from the donor's tissue attack the organs.
RGI-2001 is an investigational treatment

Start Date14 Aug 2020

Sponsor / Collaborator

REGiMMUNE Corp.

NCT04014790

/ CompletedPhase 2

An Open Label Phase 2, Study to Evaluate the Safety and Efficacy of RGI-2001 for the Prevention of Acute Graft-vs-Host Disease Compared to Contemporary Controls in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation

This Phase II open label study will evaluate the safety and efficacy of repeat doses of RGI-2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). These subjects will be compared to contemporary controls.

Start Date25 Nov 2019

Sponsor / Collaborator

REGiMMUNE Corp.

JPRN-UMIN000009607

/ CompletedPhase 2IIT

The double-blind, randomised controlled phase II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with head and neck mucosal melanoma followed by standard therapy. - Chiba NKT therapy for HNSCC

Start Date01 Apr 2013

Sponsor / Collaborator-

100 Clinical Results associated with KRN-7000 liposomal

100 Translational Medicine associated with KRN-7000 liposomal

100 Patents (Medical) associated with KRN-7000 liposomal

410

Literatures (Medical) associated with KRN-7000 liposomal

01 Jan 2025·European Journal of Medicinal Chemistry

α-GalCer sp2-iminoglycolipid analogs as CD1d-dependent iNKT modulators: Evaluation of their immunotherapeutic potential in murine models of asthma and autoimmune hepatitis

Article

Author: Ho, Chieh-Hsin ; Rocha, Gabriel ; García Fernández, José M. ; García Fernández, José M ; Chuan-Ying Lai, Alan ; Angulo, Jesús ; Chang, Ya-Jen ; Mellet, Carmen Ortiz ; Chi, Po-Yu ; Muñoz-García, Juan C. ; Muñoz-García, Juan C ; Ortiz Mellet, Carmen ; Lai, Alan Chuan-Ying ; González-Cuesta, Manuel ; Wu, Ko-Chien

Invariant natural killer T (iNKT) cells are a subset of innate T cells displaying powerful immunomodulatory functions. Despite extensive preclinical research on the use of iNKT agonist and antagonist for various diseases, translating these findings into successful clinical applications has proven challenging, leaving no approved treatments to date. Efforts to optimize therapeutic outcomes by developing alternative glycolipids to α-galactosylceramide (α-GalCer or KRN7000), the prototypical iNKT antigen, have shown improved preclinical results. However, significant obstacles remain, including the relatively laborious synthesis of α-glycosides and their vulnerability to degradation by α-glycosidases. To overcome these limitations, we explored the use of sp²-iminosugars, a class of glycomimetics, to replace the carbohydrate moiety in α-GalCer-like glycolipids. This substitution offers enhanced biostability and precise control over α-selectivity in glycosylation reactions. The resulting sp²-iminoglycolipids (sp²-IGLs) were tested for their immunomodulatory effects, demonstrating the ability to bind the α-GalCer binding site on the CD1d protein in antigen-presenting cells (APCs), and functioning as iNKT antagonists in α-GalCer-stimulated splenocytes. Notably, analogs featuring a 4-alkyl-1,2,3-aminotriazol-1-yl segment in place of the C₂₅N-acyl tail in α-GalCer additionally exhibited mild agonistic activity in the absence of α-GalCer stimulation. Computational studies support the formation of stable CD1d- sp²-IGL and CD1d - sp²-IGL - T-cell receptor complexes, with significant differences in the dynamics depending on the glycone nature and lipid tail length. These findings provide a molecular rationale for the observed experimental data. Furthermore, in vivo studies using murine models of asthma and autoimmune hepatitis have identified promising sp²-IGL candidates for further development in immunotherapy.

10 Oct 2024·Journal of Medicinal Chemistry

Fully Synthetic TF-Based Self-Adjuvanting Vaccine Simultaneously Triggers iNKT Cells and Mincle and Protects Mice against Tumor Development

Article

Author: Liu, Zhongqiu ; Li, Jinmei ; Liao, Guochao ; Ming, Wenbo ; Liao, Pan ; Luo, Xiang ; Yang, Deying ; Li, Xiaohui ; Liu, Zichun ; Li, Tongtong

The Thomsen-Friedenreich (TF) antigen has proven to be a promising target for developing novel therapeutic cancer vaccines. Here, a new strategy that TF antigen covalently coupled with KRN7000 and vizantin was developed. The resulting three-component vaccine KRN7000-TF-vizantin simultaneously triggers invariant natural killer T (iNKT) cells and macrophage-inducible C-type lectin (Mincle) signaling pathways, eliciting much stronger TF-specific immune responses than glycoprotein vaccine TF-KLH/alum and the corresponding two-component conjugate vaccines TF-KRN7000 and TF-vizantin. The analysis of IgG isotypes and the secretion of cytokines revealed that KRN7000-TF-vizantin induced Th1/Th2 mixed immune responses, where Th1 was dominant. In vivo experiments demonstrated that KRN7000-TF-vizantin increased the survival rate and survival time of tumor-challenged mice, and surviving mice rejected further tumor attacks without any additional treatment. This work demonstrates that covalently coupled KRN7000 and vizantin could serve as a promising TF-based vaccine carrier for antitumor immune therapy, and KRN7000-TF-vizantin features great potential to be a vaccine candidate.

01 Oct 2024·Immunologic Research

CCR2+TREM-1+ monocytes promote natural killer T cell dysfunction contributing towards HBV disease progression

Article

Author: Wu, Xiaojuan ; Miao, Qiang ; Wei, Bin ; Shi, Shiya ; Cai, Bei ; Luo, Limei ; Zhao, Wenling

Natural killer T (NKT) cells are amongst the most important innate immune cells against hepatitis B virus (HBV) infection. Moreover, previous studies have shown that HBV infection induced TREM-1+ expression in monocyte and secretion of inflammatory cytokines. Thus, this prompted us to elucidate the role of TREM-1+ monocytes in regulating the function of iNKT cells. Ninety patients and 20 healthy participants were enrolled in the study. The percentage and phenotype of iNKT cells and TREM-1+ monocytes were measured in the peripheral blood of healthy controls (HC), patients with chronic HBV infection (CHB), HBV-related liver cirrhosis (LC), and HBV-related acute-on-chronic liver failure (ACLF) via flow cytometry. Moreover, co-culture experiments with iNKT cells and TREM-1 overexpressing THP-1 cells were performed to determine the role of TREM-1 in the regulation of NKT cell function. We observed that the percentage of iNKT cells and CD4-iNKT cells gradually decreased, whereas the percentage of CCR2+TREM-1+ monocytes increased with the progression of the disease. In addition, activation of the TREM-1 signaling pathway induced the secretion of inflammatory cytokines leading to pyroptosis of iNKT cells and secretion of IL-17 contributing towards disease progression. Therefore, this study suggests that blocking the activation of TREM-1 in monocytes could promote the elimination of HBV by inhibiting pyroptosis of iNKT cells and restoring their function. However, further studies are required to validate these results that would help in developing new treatment strategies for patients with HBV infections.

News (Medical) associated with KRN-7000 liposomal

18 Oct 2024

·regimmune.com

REGiMMUNE and Kiji Therapeutics Announce Intention to merge

The intended merger will create a pan-global Treg specialist to use multiple modalities to target Tregs for a number of indications. Taipei, TAIWAN, and Paris, FRANCE, October 18, 2024 – REGiMMUNE, the regulatory T cell targeting drugs for immunotherapy and Kiji Therapeutics, the specialist in Induced Pluripotent Stem Cells-Mesenchymal Stem Cells (IPSC-MSC) engineered cell therapies for [...] TAIPEI, June 4, 2024 – REGiMMUNE Limited is pleased to announce that our company has recently been featured in a report by “China Times”. The article highlights our development progress of RGI-2001 and our future IPO plans. We are grateful for the attention and support from “China Times”. You can read the full article here: [...] TAIPEI, May 6, 2024 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, is pleased to announce the appointment of Dr. Steve Yang as its Chief Operating Officer (COO), effective on May 6th 2024. In this role, Dr. Yang will lead the company’s operational strategies, driving product [...] TAIPEI, April 11, 2024 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, today announces the poster presentation at the American Association of Cancer Research (AACR) Annual Meeting. The poster presentation is to highlight RGI-2001 phase 2b result, including the latest correlative analyses of changes in regulatory [...] TAIPEI, February 22, 2024 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, today announced the positive results of their phase 2b clinical trial for the prevention of acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic cell transplantation (alloHCT) at the 2024 Tandem Meeting of ASTCT and CIBMTR. [...] TAIPEI, December 28, 2023 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, today announced that the Phase 2b clinical data from 48 patients receiving RGI-2001 for the prevention of acute graft-versus-host disease (aGVHD) will be presented at the 2024 Tandem Meeting in San Antonio, Texas on [...] Taipei, July 6, 2023 – REGiMMUNE Limited (REGiMMUNE), a biotech company focused on creating innovative immunotherapies for immune disorders and cancer, today appointed Hua Nan Securities as the lead underwriter for its upcoming initial public offering (IPO) in Taiwan. The IPO is anticipated to take place in 2025, signifying an important milestone in REGiMMUNE's expansion [...] Taipei, March 29, 2023 – REGiMMUNE Limited (REGiMMUNE), a biotech company focused on creating innovative immunotherapies for immune disorders and cancer, and San Fu Biotech (SFB), a subsidiary of San Fu Chemical Co., Ltd. (4755.TW) have entered a licensing agreement to develop and commercialize RGI-2001 for the prophylaxis of acute Graft-versus-host disease (aGvHD) in major [...] RGI-2001 was well tolerated and associated with a meaningful reduction in the incidence of severe acute GVHD TAIPEI, December 12, 2022 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company developing innovative immunotherapies for immune disorders and cancer, today announced the positive results of their Phase 2b clinical trial for the prevention of acute graft-versus-host disease (aGvHD) [...] TAIPEI, November 3, 2022 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, today announced that the Phase 2b clinical data from 49 patients receiving RGI-2001 for the prevention of acute graft-versus-host disease (aGVHD) will be presented at the 2022 American Society of Hematology (ASH) Annual Meeting [...] Taipei, 16 May 2022 – REGiMMUNE Limited, a biopharmaceutical company focused on creating innovative immunotherapies for rare diseases and cancer, today announced Charlie Hsu, a seasoned financial executive, join the company's management team as Chief Financial Officer (CFO). Charlie brings more than 25 years of business experience in finance management and equity investment in both [...] REGiMMUNE Corporation has presented clinical data on RGI-2001 Intravenous Infusion for the prevention of acute GVHD in the annual meeting of the American Society of Hematology on December 5 2020. Repeat weekly doses of RGI-2001 100 μg/kg IV infusion (30min) in allogeneic bone marrow transplant is safe when given with standard GvHD prophylaxis [...] Tokyo, Japan – April 7, 2017 – REGiMMUNE Corporation announced the closing of a Series E financing on April 7th. The company raised 6 million US in this new round, which was led by SMBC Venture Capital Co., Ltd., the VC arm of Sumitomo Mitsui Banking Corporation(SMBC) and Japan Asia Investment Corporation (JAIC). Additional investors [...] We are proud to announce that we have moved our business to a new location. Our new address is as follows. 35-3 Nihonbashi Hakozaki-cho BRICK GATE 5F Chuou-ku Tokyo 103-0015 Japan.Our Telephone numbers remain the same. Tokyo Japan — July 1, 2016 — REGiMMMUNE today announced that its Board of Directors has appointed Kenzo Kosuda as Chief Executive Officer effective July 1, 2016. Yasuyuki Ishii will assume the role of Executive Chairman on July 1, 2016, and will continue to serve as the Chairman of REGiMMUNE’s Board. "This is an appropriate [...]

Phase 2Executive ChangeImmunotherapyLicense out/in

04 Jun 2024

·regimmune.com

REGiMMUNE Featured in “China Times”

TAIPEI, June 4, 2024 – REGiMMUNE Limited is pleased to announce that our company has recently been featured in a report by “China Times”. The article highlights our development progress of RGI-2001 and our future IPO plans. We are grateful for the attention and support from “China Times”. You can read the full article here: 櫃買赴日招商聚焦生技業 We will continue our commitment to developing RGI-2001 and other innovative drugs in the fields of immunology and oncology. Ends About REGiMMUNE Limited REGiMMUNE is a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies by harnessing the power of regulatory T cells (Tregs). REGiMMUNE is creating a pipeline of novel product candidates that either enhance Treg activities for immune diseases or suppress Treg activities for cancer. Corporate Contact Miranda Yu Investor Relations Manager REGiMMUNE Corporation Ltd. +886 2 2555 3377 #511 miranday@regimmune.com 2024年6月4日，台北 – 瑞格國際生技很高興宣布，近日獲得「中時新聞網」的報導，該報導介紹了本公司RGI-2001的開發進度及未來掛牌規劃，感謝「中時新聞網」的關注與支持。完整報導請見以下連結：櫃買赴日招商聚焦生技業我們將致力於推展RGI-2001的研發，並在免疫及癌症領域開發更多創新藥物。本文結束關於瑞格國際生技瑞格係為專注於自體免疫疾病與癌症，運用調控調節性T細胞(Tregs)，開發創新免疫療法之臨床生技公司。瑞格構建之全新候選藥物組合係藉由調控調節性T細胞活性，用於治療免疫疾病及癌症。媒體聯絡人余明穎 (Miranda Yu) 投資人關係經理瑞格國際生技股份有限公司 +886 2 2555 3377 #511 miranday@regimmune.com

Immunotherapy

15 Apr 2024

·regimmune.com

REGiMMUNE Announces the Poster Presentation at the AACR 2024 Annual Meeting for RGI-2001 Phase 2b latest analyses.

TAIPEI, April 11, 2024 – REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, today announces the poster presentation at the American Association of Cancer Research (AACR) Annual Meeting. The poster presentation is to highlight RGI-2001 phase 2b result, including the latest correlative analyses of changes in regulatory T (Treg) and natural killer T (NKT) cell populations to assess the cellular kinetics of RGI-2001 in the prevention of acute Graft versus host disease. Based on literature, higher numbers of NKT cells are associated with a reduced risk of acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic cell transplantation (alloHCT) (Rubio et al. 2017; Rubio et al. 2012). Patients with rapid NKT cell expansion exhibit a lower risk of GVHD and improved survival (Chaidos et al. 2012; Malard et al. 2016). Flow cytometry studies indicate peripheral NKT expansion at Day 28 in patients receiving clinical benefit from RGI- 2001.The mean levels of absolute Tregs at Day 42, 1 week following the last dose of RGI-2001, were higher in subjects who were alive and had not developed Grade II-IV aGVHD by Day 180 compared with those who had died and/or did develop aGVHD. A large percentage of activated Tregs were proliferating, with activated Tregs proliferating to a greater extent compared with nonactivated Tregs. The proliferation was greater in after- treatment compared to baseline samples. This effect was also observed in the single-dose study (Phase 1/2a RGI-2001-002). The results from exploratory correlative analyses are consistent with the proposed mechanism of action of RGI-2001. RGI-2001 may induce activation and proliferation of NKT cells, leading to a reduction in aGVHD through increasing the proliferation of activated Tregs. “Our data suggest that RGI-2001 prevents acute GVHD through NKT and Treg cells without compromising general immune function and has the potential to become a best-in-class drug for preventing acute GVHD,” said Kenzo Kosuda, CEO of REGiMMUNE. Based on these results, a phase 3 randomized controlled study is being planned to confirm the efficacy and safety of RGI-2001 in alloHCT. Dr Jack Bui,MD,Ph.D. from University of California, San Diego, is the presenter for this important poster for RGI-2001. Details of presentation, please see RGI-2001 AACR Poster Presentation. Title: Phase 2b study of alloHSCT patients receiving RGI-2001, an NKT cell activator, demonstrates safety and protection from acute GVHD, correlating with increased NKT cell number in patient blood. Authors: J. D. Bui1, C. Lee1, C. Caron1, D. Lee2, Z. DeFilipp3, Y.-B. Chen3; Session Title: PO.CT02.02 – Phase II Clinical Trials 2 Session Date and Time: April 8th 2024, 1:30 PM – 5:00 PM 1 UC San Diego, La Jolla, CA 2 REGIMMUNE, CA 3 Massachusetts General Hospital, Boston, MA Ends About RGI-2001 RGI-2001 is a liposomal injection formulation of an alpha-galactosylceramide (alpha-GalCer) analog. Alpha-GalCer binds to the CD1d receptor of antigen-presenting cells resulting in activation of invariant natural killer (iNKT) cells, resulting in the activation and expansion of regulatory T cells (Tregs), thus establishing immune tolerance. RGI-2001 is REGiMMUNE’s lead drug candidate, currently in Phase 3 planning for the prophylaxis of acute graft-versus-host disease (aGVHD). About REGiMMUNE Limited REGiMMUNE is a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies by harnessing the power of regulatory T cells (Tregs). REGiMMUNE is creating a pipeline of novel product candidates that either enhance Treg activities for immune diseases or suppress Treg activities for cancer. Corporate Contact Miranda Yu Investor Relations Manager REGiMMUNE Corporation Ltd. +886 2 2555 3377 #511 miranday@regimmune.com 2024年4月11日，台北 – 瑞格國際生技，一家致力於開發免疫性疾病和癌症新型療法的臨床階段生技公司，今天宣布在美國癌症研究協會 (American Association for Cancer Research, AACR) 年度會議上進行了海報發表。這次發表旨在進一步分析RGI-2001第2b期試驗的結果，包括最新的相關分析，評估RGI-2001在預防急性移植物抗宿主病 (acute graft-versus-host disease, aGVHD) 中的細胞動力學，包括調節性T (regulatory T, Treg) 細胞和自然殺手T (natural killer T, NKT) 細胞數量的變化。根據文獻，NKT細胞數量較高的患者在異體造血幹細胞移植 (allogeneic hematopoietic cell transplantation, alloHCT) 後急性移植物抗宿主病的風險降低 (Rubio et al. 2017; Rubio et al. 2012) ，NKT細胞擴增速度較快的患者發生GVHD的風險較低並且有較佳的生存率 (Chaidos et al. 2012; Malard et al. 2016)。 RGI-2001臨床2b期試驗的流式細胞儀分析數據表明，接受RGI-2001治療且後續無發生aGVHD的受試者中，第28天出現外周NKT細胞擴增，第42天，也就是完成RGI-2001最後一劑給藥後一週，Treg細胞數的平均水平較已死亡和/或發展aGVHD的受試者之Treg細胞數高。RGI-2001用藥後，大部分活化Treg細胞在進行增殖，與未活化Treg細胞相比的增殖幅度更大。與基線樣本相比，RGI-2001治療後Treg細胞的增殖程度更大，這一效果也在臨床1/2a期的單劑量研究中觀察到。相關分析的結果與RGI-2001的作用機制一致，RGI-2001可能通過誘導NKT細胞的活化和增殖，進而增加活化Tregs的增殖來降低aGVHD風險，。 REGiMMUNE的執行長小須田建三先生表示：「我們的數據表明，RGI-2001通過NKT和Treg細胞預防急性GVHD，並且不會降低一般免疫功能，有望成為預防急性GVHD的同類最佳 (best-in-class) 藥物。」根據這些結果，REGiMMUNE規劃進行臨床3期隨機對照研究，以確認RGI-2001在alloHCT中的有效性和安全性。加州大學聖地牙哥分校的Jack Bui博士是此次關於RGI-2001臨床試驗結果海報的主講人，海報詳情請參閱RGI-2001 AACR Poster Presentation。標題: Phase 2b study of alloHSCT patients receiving RGI-2001, an NKT cell activator, demonstrates safety and protection from acute GVHD, correlating with increased NKT cell number in patient blood. 作者: J. D. Bui1, C. Lee1, C. Caron1, D. Lee2, Z. DeFilipp3, Y.-B. Chen3; 會議標題: PO.CT02.02 – Phase II Clinical Trials 2 發表日期及時間: April 8th 2024, 1:30 PM – 5:00 PM 1 UC San Diego, La Jolla, CA 2 REGIMMUNE, CA 3 Massachusetts General Hospital, Boston, MA 本文結束關於RGI-2001 RGI-2001係為α-半乳糖神經醯胺(α-Galactosylceramide, α-GalCer)之微脂體注射製劑，α-GalCer與抗原呈遞細胞(Antigen Presenting Cells)上之CD1d配體結合，透過活化恆定自然殺手T細胞(iNKT)，近一步活化並擴增調節性T細胞，建立免疫耐受性。RGI-2001為瑞格國際生技主要之候選藥物，聚焦急性移植物抗宿主疾病(aGvHD)之預防，將於2024年開展美國之臨床3期試驗。關於瑞格國際生技瑞格係為專注於自體免疫疾病與癌症，運用調控調節性T細胞(Tregs)，開發創新免疫療法之臨床生技公司。瑞格構建之全新候選藥物組合係藉由調控調節性T細胞活性，用於治療免疫疾病及癌症。媒體聯絡人余明穎 (Miranda Yu) 投資人關係經理瑞格國際生技股份有限公司 +886 2 2555 3377 #511 miranday@regimmune.com

Phase 2ImmunotherapyAACRPhase 3Clinical Result

100 Deals associated with KRN-7000 liposomal

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Indication	Highest Phase	Country/Location	Organization	Date
Graft vs Host Disease	Phase 2	Japan	REGiMMUNE Corp.	30 Jan 2022
Hematologic Neoplasms	Phase 2	Japan	REGiMMUNE Corp.	30 Jan 2022
Acute Graft Versus Host Disease	Phase 2	United States	REGiMMUNE Corp.	25 Nov 2019
Acute Lymphoblastic Leukemia	Phase 1	United States	REGiMMUNE Corp.	14 Aug 2020
Chronic Myelomonocytic Leukemia	Phase 1	United States	REGiMMUNE Corp.	14 Aug 2020
Hodgkin's Lymphoma	Phase 1	United States	REGiMMUNE Corp.	14 Aug 2020
Myelodysplastic Syndromes	Phase 1	United States	REGiMMUNE Corp.	14 Aug 2020
Myeloproliferative Disorders	Phase 1	United States	REGiMMUNE Corp.	14 Aug 2020
Non-Hodgkin Lymphoma	Phase 1	United States	REGiMMUNE Corp.	14 Aug 2020
Hepatitis C, Chronic	Discovery	Netherlands	Kyowa Kirin Co., Ltd.	01 Aug 2003

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04014790 (RGI-2001-003, CTgov)	Phase 2	Acute Graft Versus Host Disease	49	Standard of Care+RGI-2001	hoeypqqkmz(uazzjwnxmb) = zhzrdefwbj qkszmgwowu (medlcgjtyo, iijprsufsg - homwabayox) View more	-	17 Apr 2024
NCT04014790 (Company_Website) Manual	Phase 2	Acute Graft Versus Host Disease	-	RGI-2001 + standard immunosuppression	erbyuwffiv(ahpjnymoca) = zceztzvlkl cghqcbuwvv (rmcsblkyzi ) View more	Positive	22 Feb 2024
NCT04014790 (Company_Website) Manual	Phase 2	Acute Graft Versus Host Disease	-	CIBMTR cohort	erbyuwffiv(ahpjnymoca) = fctaykusks cghqcbuwvv (rmcsblkyzi ) View more	Positive	22 Feb 2024
NCT04014790 (RGI-2001-003, EBMT2023)	Phase 2	Acute Graft Versus Host Disease	49	RGI-2001 IV infusion	gvvngkrqgn(sznbfvkdrn) = fwgxtkeovk waieoznpee (fwyurzqqyl, 10.2 - 34.3)	-	23 Apr 2023
NCT04014790 (RGI-2001-003, Tandem Meetings ASTCT and CIBMTR2023)	Phase 2	Acute Graft Versus Host Disease	49	RGI-2001	hhqgmnqhsv(aixwxsqtwt) = 6% bjqwzyhfzv (erbpcallxo ) View more	Positive	01 Feb 2023
NCT04014790 (RGI-2001-003, ASH 12022 \| ASH 22022) Manual	Phase 2	Acute Graft Versus Host Disease	53	RGI-2001 100 ug/kg	xylinehfar(yonplpkucg) = gdfsgzmowd tycokadjgy (tspwjuenfr, 10.2 - 34.3) View more	Positive	15 Nov 2022

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