European Medicines Agency Validates Kite’s Marketing Application for Chimeric Antigen Receptor (CAR) T Cell Therapy for Mantle Cell Lymphoma

Investigational KTE-X19 To Be First Chimeric Antigen Receptor (CAR) T Cell Therapy for Mantle Cell Lymphoma in Europe if Approved Kite, a Gilead Company, today announced that the company’s Marketing Authorization Application (MAA) for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL),

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Exploding cancer cells can cause serious side effects in CAR-T cell therapies

Blocking a protein makes cells shrink instead, causing fewer problems Techniques to genetically modify patient immune cells have revolutionized the fight against hard-to-treat cancers. But they can come with dangerous side effects. Now, researchers have found one reason why. A particularly messy form of cell death sparks severe inflammation in patients receiving CAR-T cell immunotherapy for blood

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Stanford researchers program cancer-fighting cells to resist exhaustion, attack solid tumors in mice

CAR-T cells are remarkably effective against blood cancers, but their effect can be transient as the cells become exhausted. Stanford researchers found a way to keep the cells effective in mice with human tumors. A new approach to programming cancer-fighting immune cells called CAR-T cells can prolong their activity and increase their effectiveness against human

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Novartis’ new cell therapy facility could ease manufacturing squeeze for CAR-T med Kymriah

Novartis’ big push into cell and gene therapy hasn’t been the smoothest of rides, with a data manipulation scandal hamstringing Zolgensma and manufacturing concerns hurting CAR-T cancer therapy Kymriah. Could a new European facility help turn around the latter’s production bottleneck?  Novartis last week opened its newest cell and gene therapy facility in Stein, Switzerland, giving the

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University of Miami Initiates CAR-T Clinical Trial in Myasthenia Gravis

Neuromuscular experts with the University of Miami Health System and the Miller School of Medicine will launch a Phase 1/2 clinical trial (NCT04146051) using the CAR-T drug, Descartes-08, to treat patients with generalized myasthenia gravis. Generalized myasthenia gravis (GMG) is a rare disease and a chronic autoimmune condition in which auto-antibodies attack specific proteins at the

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AffyImmune Therapeutics Announces IND Approval for a First-in-Man Trial of Affinity-Tuned CAR-T cells for Patients with Advanced, Refractory Thyroid Cancer

AffyImmune Therapeutics, an emerging leader in CAR-T therapies, today announced FDA approval of the company’s investigational new drug (IND) application for AIC100, an affinity-tuned CAR-T cell that received Orphan designation for advanced thyroid cancer. The trial: Phase I study of AIC100 in relapsed and or refractory advanced thyroid cancer and anaplastic thyroid cancer, is sponsored by Weill

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CARsgen Announces Investigational CAR-T Therapy CT053, after PRIME eligibility by EMA, Granted RMAT Designation by the U.S. FDA for R/R Multiple Myeloma

CARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of

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CAR-T cells therapy in Italy. Interview with Prof. Locatelli, Chairman of the Italian Project Group

“The Italian government has decided to invest 60 million euros on CAR-T therapies, 10 million for each of the 6 pharmaceutical workshops”. This was stated by Health Minister Roberto Speranza, explaining to the joint committees of the Senate and the House the program lines of his department. CAR-T cell therapy consists of genetic manipulation of

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The Italian way to CAR-T cells.

The announcement by the Health Minister Speranza: “60 million to 6 workshops to produce Car-T against cancer” The Car-t therapies are “a strategic segment on which the government has decided to invest 60 million euros, foreseeing 10 million for each pharmaceutical workshop”, or high-tech laboratories in which the patient’s immune cells against tumors are modified.

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Potency of CAR T-Cell Therapy for Myeloma May Vary by Disease Stage

Source CancerNetwork CAR T cells are a more effective therapy if manufactured for patients with multiple myeloma prior to the onset of relapsed or refractory disease, according to study results1 published in Blood Advances. “CAR T cells directed against the B-cell maturation antigen (BCMA) have demonstrated impressive initial results, but available data suggest that most patients with initial responses

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