Hematology

Estrella noted that the patient had been diagnosed with follicular lymphoma grade 3A with high-risk 3B symptoms.

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The data, from the CARTITUDE-4 clinical trial, compared outcomes to patients treated with standard of care options.

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Enrollment difficulties were cited as the reason for discontinuing recruitment activities for KarMMa-9.

The approvals are indicated for patients 12 years and older.

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The product is currently being evaluated in a phase 1/1b clinical trial.

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VNX-101 is intended to transduce cells of the liver, causing them to express a transgene coding for a bispecific T-cell engager.

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The company also discontinued its other clinical programs as well, which included small molecule and monoclonal antibody modalities.

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Pending the results of the trial, Cartesian plans to eventually evaluate Descartes-15 for the treatment of autoimmune diseases.

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Among the treated patients, the complete response (CR) rate in adults was 82% and the CR rate in children was 93%.

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The NMPA’s decision was made with reference to results from the phase 2 CARTIFAN-1 clinical trial (NCT03758417), which took place at multiple sites in China.

The approved indication specifically covers adults with r/r MCL who have previously been treated with at least 2 lines of systemic therapy including BTKis.