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Phase classification, Trial completion date, Trial primary completion date: RAPA-201 Therapy of Solid Tumors (clinicaltrials.gov) - Mar 30, 2023
P1/2, N=22, Recruiting,
2 RAPA-201 is also resistant to chemotherapy, including carboplatin (CBCCA), paclitaxel (PTX), and topotecan (Park JH et al, separate abstract submitted to SITC 2023)...Autologous RAPA-201 were manufactured using one-week culture in temsirolimus- and IFN-?-containing media (cryopreserved, 80 Phase classification: P2 --> P1/2 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
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Metabolically Reprogrammed Polyclonal Autologous Rapa-201 Cell Therapy Yields a Promising Safety and Efficacy Profile in Relapsed and Refractory Multiple Myeloma (RRMM) (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4483;
P2
Now, we are evaluating temsirolimus for manufacture of second-generation RAPA-201 cells...Bridging chemotherapy during manufacturing (Cycle 1) and host conditioning prior to RAPA-201 infusion consisted of the 14-day PC regimen [pentostatin (4 mg/m 2 IV; days 1, 4, 8, 12; dose adjusted/omitted with renal insufficiency); cyclophosphamide (100-200 mg PO, days 1-5 and days 8-12)]...RAPA-201 therapy represents a new paradigm that utilizes stringent mTOR inhibition to reprogram Th1/Tc1 cells for enhanced metabolic fitness and induction of in vivo T cell clonal expansion, thus providing an alternative to gene-modified targeted T cell therapy. With these promising safety and efficacy results, current RAPA-201 developmental efforts are directed towards completing protocol accrual in parallel with the design and implementation of next-generation clinical trials.
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Enrollment open: RAPA-201 T Cell Therapy for Relapsed, Refractory Multiple Myeloma (clinicaltrials.gov) - Oct 21, 2020
P2, N=27, Recruiting,
With these promising safety and efficacy results, current RAPA-201 developmental efforts are directed towards completing protocol accrual in parallel with the design and implementation of next-generation clinical trials. Not yet recruiting --> Recruiting
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