Three deaths in CAR-T trials prompt halt by Novartis; Bristol Myers programs also paused
Novartis paused eight clinical trials of its rapcabtagene autoleucel (rap-cel) therapy after three patients died from immune effector cell-associated hemophagocytic syndrome (IEC-HS). This rare, life-threatening immune response occurred during tests for neurological and autoimmune diseases, including rheumatoid arthritis and lupus. Bristol Myers Squibb also halted its similar CAR-T programs following separate safety signals. Both companies informed Endpoints News of the pauses to review safety issues. Wall Street analysts suggest that stricter manufacturing and enrollment protocols may be necessary to prevent future hazards.
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- ✓ Novartis paused eight clinical trials of its experimental CAR-T therapy rap-cel.
- ✓ Three patients died in Novartis trials following severe immune reactions.
- ✓ The deaths involved immune effector cell-associated hemophagocytic syndrome (IEC-HS).
- ✓ Bristol Myers Squibb paused its CAR-T trials after separate safety signals.
What changed
The update identifies the specific drug as rap-cel, names the cause of death as IEC-HS, and confirms eight trials were paused.
Live updates
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Novartis and Bristol Myers Squibb Pause CAR-T Trials After Patient Deaths
Novartis paused eight clinical trials of its rapcabtagene autoleucel (rap-cel) therapy after three patients died from immune effector cell-associated hemophagocytic syndrome (IEC-HS). This rare, life-threatening immune response occurred during tests for neurological and autoimmune diseases, including rheumatoid arthritis and lupus. Bristol Myers Squibb also halted its similar CAR-T programs following separate safety signals. Both companies informed Endpoints News of the pauses to review safety issues. Wall Street analysts suggest that stricter manufacturing and enrollment protocols may be necessary to prevent future hazards.
Why it matters
CAR-T therapy modifies a patient's own T cells to target specific cells before reinfusion. While established in oncology, applying this technology to autoimmune diseases introduces new risks of severe immune reactions. These pauses signal a broader safety challenge for the sector.
What is confirmed
- Novartis paused eight clinical trials of its experimental CAR-T therapy rap-cel.
- Three patients died in Novartis trials following severe immune reactions.
- The deaths involved immune effector cell-associated hemophagocytic syndrome (IEC-HS).
- Bristol Myers Squibb paused its CAR-T trials after separate safety signals.
- Rap-cel was being tested for autoimmune and neurological diseases such as lupus and rheumatoid arthritis.
Still unconfirmed
- Wall Street analysts believe cautious manufacturing and study enrollment could avoid future safety hazards.
What to watch next
- Results of the safety reviews from Novartis and Bristol Myers Squibb regarding trial resumption.
- FDA guidance or regulatory action concerning IEC-HS in autoimmune CAR-T applications.
confidence 95%Sources used for this update (4)
- 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.biospace.com — Novartis’ and BMS’ paused CAR T trials, RevMed’s pancreatic cancer approval, more MFN deals
- finance.yahoo.com — Novartis (NVS)’s Cell Therapy Promise Meets a Safety Challenge
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Novartis halts CAR-T trials after 3 patient deaths
Novartis has paused its autoimmune CAR-T cell therapy trials due to three patient deaths. The trials were halted as a precautionary measure after severe immune reactions linked to the therapy were reported. Bristol Myers Squibb also paused its CAR-T trials. The CAR-T cell therapy is an experimental treatment that involves removing T cells from a patient's blood, modifying them to recognize cancer cells, and reinfusing them back into the patient.
Why it matters
The halted trials are part of a larger investigation into the safety of CAR-T cell therapies. CAR-T cell therapies have shown promise in treating certain types of blood cancers, but they can also cause severe side effects. The therapy is being explored for use in autoimmune diseases.
What is confirmed
- Novartis halted its autoimmune CAR-T cell therapy trials due to three patient deaths.
- Bristol Myers Squibb also paused its CAR-T trials.
- The patient deaths were caused by severe immune reactions linked to the CAR-T therapy.
- Novartis halted eight CAR-T cell clinical trials.
What to watch next
- Further investigation into the cause of the patient deaths
- Novartis' plan to resume the halted trials
- Regulatory response to the halted trials
confidence 100%Sources used for this update (10)
- 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
- GuruFocus — NVS Looks 16.5% Overvalued on GF Value™ Amid Dividend Safety Foc
- Bloomberg.com — Novartis Pauses Autoimmune Drug Trials After Three Patients Die
- Reuters — Novartis pauses trials of experimental cell therapy after three deaths
- Barron's — Why Novartis Stock Is Heading for Its Best Day Since 2023 After 3 Patient Deaths
- www.emjreviews.com — Novartis halts eight CAR-T cell therapy trials after deaths
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