TC BioPharm Begins Dosing Phase 2B Clinical Study Evaluating Its Lead Compound, OmnImmune, In Patients With Acute Myeloid Leukemia
TC BioPharm Begins Dosing Phase 2B Clinical Study Evaluating Its Lead Compound, OmnImmune, In Patients With Acute Myeloid Leukemia
- 3 Patients Dosed in 5 Patient Safety Cohort
- 在 5 個患者安全隊列中，有 3 名患者接受了劑量
EDINBURGH, Scotland, Nov. 22, 2022 /PRNewswire/ -- TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ:TCBP) (NASDAQ:TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer today announced the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia (AML).
蘇格蘭愛丁堡，2022年11月22日 /PRNewswire/ — TC Biopharm（Holdings）PLC（“TC Biopharm” 或 “公司”）（納斯達克股票代碼：TCBP）（納斯達克股票代碼：TCBPW）今天宣佈，其在同種異體單體 OmnImmune 的 2b 期臨床試驗中的前三名患者的劑量改良細胞療法側重於治療急性髓系白血病（AML）。
The initial 5 patients in the trial are deemed a "safety cohort", spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP's step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient.
試驗中最初的5名患者被視爲 “安全隊列”，間隔兩週，由監督委員會進行安全審查，以確認沒有與藥物相關的毒性問題，在給5名患者服藥後，該研究將進入開放招生階段。該安全隊列與TCBP的分步臨床試驗進展一致，從1b階段的捐贈者匹配轉變爲不在捐贈者與患者之間進行HLA匹配的通用捐贈者模型。
"The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune, for patients with AML and for TC BioPharm's emerging pipeline of 'off-the-shelf' gamma-delta T cell therapies," said Bryan Kobel, CEO of TC BioPharm. "This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7x10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023."
“TC BioPharm首席執行官布萊恩·科貝爾說，我們的2B期試驗的啓動是我們開發針對急性髓細胞白血病患者的主要療法OmnImmune，也是TC BioPharm新興的'現成'gamma-delta T細胞療法產品線的關鍵里程碑。“這項研究設計包括在公開招生之前的5名患者安全隊列，我們預計將在2022年底之前完成安全隊列。該研究的下一步是進行19名患者的中期審查，這將使TCBP能夠審查劑量並將劑量增加到更高的水平，如果我們的團隊認爲有必要提高療效，或者我們可以選擇維持目前的劑量水平，即每劑7x10^7或7億個細胞。我們期待着推進我們的2b期試驗，目標是在2023年1月開放招生，並努力在2023年上半年擴大我們在美國的臨床工作。”
TC BioPharm's Phase 2B trial, dubbed ACHIEVE, will enroll adults diagnosed with AML who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes (MDS), conditions that can occur when the blood-forming cells in the bone marrow become abnormal. The trial is expected to enroll approximately 37 patients.
TC BioPharm的2B期試驗名爲ACHIVE，將招收被診斷患有急性髓細胞白血病但已復發或對先前治療有難治性的成年人，以及骨髓增生異常綜合徵（MDS）患者的隊列，這種疾病可能發生在骨髓中的造血細胞異常時。該試驗預計將招收約37名患者。
譯文內容由第三人軟體翻譯。