Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Preliminary Clinical Data on Relma-Cel Injection in Adults with Active Systemic Lupus Erythematosus in China at the Eular 2024 Congress


News provided by

JW Therapeutics

30 May, 2024, 10:10 GMT

Share this article

Share toX

Share this article

Share toX

SHANGHAI, May 30, 2024 /PRNewswire/ -- JW (Cayman) Therapeutics Co. Ltd (the "Company" or "JW Therapeutics", together with its subsidiaries, the "Group"), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, presented the preliminary clinical data on relmacabtagene autoleucel ("relma-cel") injection in adults with active systemic lupus erythematosus ("SLE") in China at the 2024 European Alliance of Associations for Rheumatology Congress ("EULAR 2024").

Updates on safety and efficacy of relma-cel in adults with SLE in China (abstract number: 3246; Poster number: POS0054)

SLE is a chronic autoimmune disease causing widespread inflammation and tissue damage in the affected organs. There are about one million SLE patients in China, ranking the first worldwide in total numbers and the second in incidence rate. Current conventional therapies include corticosteroids, antimalarial drugs, non-steroidal anti-inflammatory drugs (NSAIDs), cytotoxic drugs and immunosuppressive/modulatory agents. However, conventional treatments are poorly tolerated over time, which affects the clinical efficacy, thus leading to poor disease control with organ damage and further affecting prognosis and long-term survival, especially in patients with moderately to severely active SLE who require high doses of corticosteroids and immunosuppressants.

This is a single-arm, open-label, multi-center dose escalation study (NCT05765006) in China. Participants will receive an intravenous infusion of CAR-T cells at doses of 25×10^6(25M), 50×10^6(50M), 75×10^6(75M), or 100×10^6(100M), to evaluate the safety and efficacy of relma-cel in SLE patients.

As of April 8, 2024, a total of 12 patients enrolled and received the single infusion of relma-cel. Safety, pharmacokinetics and pharmacodynamics ("PK/PD") and efficacy assessments were conducted across low, medium, and high dosage groups, with the longest follow-up duration of more than 9 months. At EULAR 2024, we presented data from patients in the low-dose group with relatively longer follow-up period, up to the data cutoff date of December 18, 2023.

Three patients with active SLE received single intravenous infusion of relma-cel at the dose level of 25M and completed at least 4-months follow-up. All the three patients were female with multiorgan involvement and previously exposed to high-dose steroids and several immunosuppressive treatments. Two had a medical history of more than ten years, and two patients received biological agents. After relma-cel administration, clinical signs and symptoms of SLE patients continued to be improved: SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) ("SRI-4") score dramatically decreased from 8~14 to 0/1, and all the three patients achieved SRI-4 while two patients reached the more stringent lupus low disease activity status (LLDAS). As of the data cut-off, all the three patients no longer used corticosteroids nor immunosuppressants. PK/PD data once again confirmed the proliferation of relma-cel in vivo and complete depletion of peripheral blood B cells. In addition, relma-cel demonstrated manageable safety profile. Cytokine release syndrome ("CRS") occurred in two patients (one had Grade 1 and another had Grade 3). No neurotoxicity (NT) occurred. Cytopenia occurred in two patients. Infection, macrophage activation syndrome (MAS), and effusion were observed in one single patient. The patients completely recovered around Day 60 with appropriate treatments.

The above three patients are still under study follow-up. Over the follow-up time exceeding 6-months, all three patients demonstrated ongoing improvements in both disease activity and clinical symptoms. Our preliminary data showed that relma-cel, even at a dosage significantly lower than that of hematological tumors, can effectively induce profound and lasting remissions in patients with moderate to severe SLE, while maintaining a favorable safety profile. These encouraging results bolster JW Therapeutics' potentials for further clinical development in SLE and other autoimmune diseases.

Up to date, the investigator-initiated trial ("IIT") is actively ongoing to accumulate data from a larger cohort with longer follow-up periods. To summarize the efficacy data for nine patients at different dose levels (three cases in the 25M dosage group, three cases in the 50M dosage group, and three cases in the 75M dosage group), 100% patients achieved an SRI-4 response at 3-month after relma-cel infusion. Notably, for those four patients (three cases from the 25M group and one from the 50M group) followed up for at least six months, still maintained a 100% SRI-4 response rate. Among all patients who received relma-cel infusion (three cases in the 25M group, three cases in the 50M group, and six cases in the 75M group), eleven patients (91.67%) stopped using traditional corticosteroids and immunosuppressants. This has not only alleviated the medication burden on patients but also minimized potential side effects. Additionally, significant improvements in organ damage have been observed in most patients, with remarkable reductions in SLE disease activity and anti-double-stranded DNA (dsDNA) antibody levels, as well as a notable decrease in the 24-hour urinary protein levels post-infusion. And 100% patients achieved rapid complete peripheral B-cell depletion after the infusion, with a median time of four days to onset. Across all dosage groups, CAR-T cells rapidly expanded, reaching peak levels around Day 8, and a clear dose-response relationship was observed. Patients in the higher dosage groups exhibited higher peak pharmacokinetic (PK) values, and longer-lasting duration of B-cell depletion.

Patients in all dosage groups showed good safety and tolerability, with only one case of Grade 3 CRS and no instances of Grade 3 or above neurotoxicity. Additionally, only two patients experienced Grade 3 infections, and all adverse events resolved following appropriate treatment.

The preliminary data from this IIT indicated that relma-cel could achieve deep and durable disease remission in patients with moderate to severe SLE, with a favorable safety profile. Based on the available/published clinical trial data, this study stands out among all clinical studies of CAR-T therapy in SLE due to its largest number of patients enrolled and the longest follow-up period, offering us robust efficacy, PK/PD, and safety data. As the pioneering commercial CAR-T therapy to receive the first Investigational New Drug (IND) approval for SLE treatment, relma-cel shows promising prospects for swift progression to the Biologics License Application (BLA) stage. We anticipate further communications with regulatory authorities to hasten the commercialization of this groundbreaking treatment and offer a transformative therapeutic option to those living with SLE.

Dr. Mark J. Gilbert, Chief Medical Officer of JW therapeutics, said, "Despite the recent emergence of novel biologics and therapies for SLE, many SLE patients still do not respond to available treatments, and there is currently no reliable treatment strategy to achieve drug-free remissions or even to cure the disease. The short-term follow-up data from this study have preliminarily shown that low-dose relma-cel injection has a favorable safety profile in SLE patients, and is able to bring about deep remission, especially enabling patients to achieve low disease activity or even drug-free remission, which makes its application in the treatment of SLE a promising prospect."

About Relmacabtagene Autoleucel Injection

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBLC) after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.

About JW Therapeutics

JW Therapeutics (Stock Code: 2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, and is committed to becoming an innovation leader in cell immunotherapy. Founded in 2016, JW Therapeutics has built a world-class platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and worldwide, and leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.

Forward-Looking Statements

The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.

Modal title

Also from this source

JW Therapeutics Announces NMPA Approval of the Supplemental Biological License Application for Carteyva® in Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma

JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell...

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Pharmaceuticals

Pharmaceuticals

Banking & Financial Services

Banking & Financial Services

News Releases in Similar Topics

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.