Novartis Pauses Autoimmune Cell Therapy Studies After Deaths
Novartis suspended eight clinical trials of its rap-cel CAR-T therapy after three patients died from immune effector cell-associated hemophagocytic syndrome (IEC-HS). This rare complication occurs during the treatment of neurological and autoimmune diseases such as rheumatoid arthritis and lupus. Bristol Myers Squibb also paused its Zola-cel trials for autoimmune disorders as a precaution. Both companies have notified regulators and researchers of these safety reviews to address severe immune reactions and inflammatory events.
What changed
The deaths at Novartis are now specifically identified as immune effector cell-associated hemophagocytic syndrome (IEC-HS).
Live updates
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Novartis and Bristol Myers Squibb Pause Autoimmune CAR-T Trials After Fatalities
Novartis suspended eight clinical trials of its rap-cel CAR-T therapy after three patients died from immune effector cell-associated hemophagocytic syndrome (IEC-HS). This rare complication occurs during the treatment of neurological and autoimmune diseases such as rheumatoid arthritis and lupus. Bristol Myers Squibb also paused its Zola-cel trials for autoimmune disorders as a precaution. Both companies have notified regulators and researchers of these safety reviews to address severe immune reactions and inflammatory events.
Why it matters
CAR-T therapies engineer a patient's own immune cells to attack specific targets. While used in cancer, expanding these treatments to autoimmune conditions introduces new safety risks regarding systemic inflammation.
What is confirmed
- Novartis paused eight clinical trials of rap-cel following three patient deaths.
- The fatalities resulted from immune effector cell-associated hemophagocytic syndrome (IEC-HS).
- Bristol Myers Squibb paused its Zola-cel autoimmune trials as a precaution.
- Rap-cel was being tested for neurological and autoimmune diseases including lupus and rheumatoid arthritis.
What to watch next
- FDA or regulatory decisions on the resumption of rap-cel and Zola-cel trials
- Updated safety protocols for CAR-T enrollment in autoimmune studies
confidence 100%Sources used for this update (4)
- finance.yahoo.com — Novartis (NVS)’s Cell Therapy Promise Meets a Safety Challenge
- www.yahoo.com — Novartis, Bristol Myers halt autoimmune CAR-T trials after deaths
- www.marketscreener.com — Bristol Myers Squibb Paused Zola-Cel Trials Over Safety Concerns
- www.biopharmadive.com — Trailing rivals, AbbVie scores win with dual-acting myeloma drug
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Novartis and Bristol Myers Squibb Pause Autoimmune CAR-T Trials
Novartis has suspended eight clinical trials of its CD19-directed CAR-T therapy, rapcabtagene autoleucel (rap-cel), following three patient deaths caused by severe immune reactions. Bristol Myers Squibb also voluntarily paused enrollment in its Zola-cel autoimmune studies due to transient inflammatory events. Both companies informed Endpoints News of these safety reviews. Wall Street analysts suggest that stricter manufacturing, enrollment protocols, and side effect management are necessary to prevent future safety hazards in the development of cell therapies for autoimmune conditions.
Why it matters
CAR-T therapies involve modifying a patient's T cells to attack specific targets in the body. While used in oncology, applying this technology to autoimmune diseases carries risks of systemic overreaction. These pauses highlight the volatility of experimental immunotherapies when treating non-cancerous conditions.
What is confirmed
- Novartis paused eight clinical trials of its CAR-T therapy rap-cel after three patients died.
- The Novartis therapy is a CD19-directed CAR-T treatment known as rapcabtagene autoleucel.
- Bristol Myers Squibb paused enrollment in its Zola-cel autoimmune studies due to transient inflammatory events.
- Both Novartis and Bristol Myers Squibb reported these pauses to Endpoints News.
Still unconfirmed
- Wall Street analysts believe cautious manufacturing and enrollment could help developers avoid future safety hazards.
What to watch next
- Regulatory decisions on whether the paused trials can resume with modified protocols.
confidence 95%Sources used for this update (7)
- www.biopharmadive.com — Autoimmune CAR-T faces tough questions after Novartis, Bristol Myers study halts
- www.medicalbrief.co.za — Novartis CAR T trials halted after three deaths
- www.thejakartapost.com — Health News & Mental Health Trends and Updates
- www.insidermonkey.com — Novartis (NVS)’s Cell Therapy Promise Meets a Safety Challenge
- finance.yahoo.com — Panmure Liberum says OxfordBiomedica share fall overdone after Novartis and BMS pause trials
- www.bioprocessintl.com — Novartis halts CAR-T therapy trials due to three patient fatalities, BMS follows
- www.pharmexec.com — Novartis, Bristol Myers Pause Autoimmune CAR-T Trials Over Safety Concerns: Report
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Novartis and Bristol Myers Pauses Autoimmune CAR-T Trials After Deaths
Novartis suspended eight cell therapy trials, including immunology and neurology studies, after three patients died from immune effector cell-associated hemophagocytic syndrome. This condition occurs when the immune system overreacts and attacks its own organs. Bristol Myers Squibb also paused some CAR-T trials, citing separate observations of transient and reversible inflammatory events. Both companies halted their respective programs due to these safety concerns regarding experimental cell therapies designed to treat autoimmune conditions.
Why it matters
CAR-T therapy traditionally treats cancers by engineering T-cells to attack tumors. Applying this technology to autoimmune diseases aims to reprogram the immune system to stop attacking healthy tissue. These pauses indicate significant safety hurdles in transitioning the therapy from oncology to immunology.
What is confirmed
- Novartis paused eight cell therapy trials including immunology and neuro studies.
- Three patients died during Novartis CAR-T trials.
- Bristol Myers Squibb paused some CAR-T trials after observing transient and reversible inflammatory events.
- Novartis deaths were caused by immune effector cell-associated hemophagocytic syndrome.
What to watch next
- Regulatory findings on the cause of the inflammatory events at Bristol Myers Squibb
- Novartis decision on whether to resume trials with modified safety protocols
confidence 95%Sources used for this update (9)
- Endpoints News — Three deaths in CAR-T trials prompt halt by Novartis; Bristol Myers programs also paused
- Fierce Biotech — UPDATED: Novartis halts autoimmune CAR-T trials after 3 deaths, as BMS also pauses studies
- BioPharma Dive — Novartis, Bristol Myers pause autoimmune CAR-T trials due to safety concerns
- WSJ — Novartis Pauses Autoimmune Cell Therapy Studies After Deaths
- FirstWord Pharma — Novartis pauses immunology, neuro CAR-T studies after three patient deaths
- Bloomberg.com — Novartis Pauses Autoimmune Drug Trials After Three Patients Die
- Reuters — Novartis pauses trials of experimental cell therapy after three deaths
- www.biospace.com — Novartis pauses CAR T studies due to 3 deaths; BMS follows suit after safety events
- www.theweek.in — Novartis pauses 8 cell therapy trials after three die due to severe immune reaction