TapImmune Begins Phase 2 Trial of T-cell Therapy for Platinum-sensitive Ovarian Cancer Patients

TapImmune Begins Phase 2 Trial of T-cell Therapy for Platinum-sensitive Ovarian Cancer Patients
TapImmune has initiated a Phase 2 clinical trial to evaluate the T-cell therapy TPIV 200 in platinum-sensitive ovarian cancer patients. Following regulatory and Investigational Review Board (IRB) approval, the first three clinical sites were allowed to begin enrolling patients. The multicenter, randomized Phase 2 clinical trial (NCT02978222) will evaluate the activity of TPIV 200, a T-cell therapy that targets the folate receptor alpha protein, as a consolidation treatment following completion of at least four cycles of a platinum-containing regimen. The study will enroll 80 patients with recurrent platinum-sensitive, non-mucinous ovarian, fallopian tube, or primary peritoneal cancer. The trial's primary endpoints include the assessment of progression-free survival following two years of treatment and time to disease progression or recurrence of ovarian cancer. Secondary endpoints include a two-year post-treatment assessment of overall survival (OS), best overall response, including complete responses and partial responses, disease control rate, response rate, and cancer antigen (CA)-125 response. The clinical trial has Fast Track designation from the U.S. Food and Drug Administration (FDA), which also granted TPIV 200 Orphan Drug s
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