Partial Clinical Hold Lifted on iMMagine-1 Phase 2 Clinical Program

“We have worked closely with FDA to expeditiously resolve the clinical hold and we thank them for their collaboration and dialogue throughout this process,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “During the review process, we updated our trial protocol, and were pleased that FDA allowed for expanded bridging therapies, which better aligns our protocol with current clinical practice. As a key step to enhancing protocol adherence related to the prevention and management of the risk of adverse events, we retrained clinical sites. Importantly, during the partial clinical hold, FDA approved dosing of all 17 patients who had been enrolled but not yet dosed prior to the hold, minimizing treatment disruption for patients and clinicians. We and our partners at Kite remain confident in CART-ddBCMA’s potential as a best-in-class therapy for the treatment of patients with rrMM given the totality of data to date across our studies. We have a strong balance sheet funding operations through BLA filing and into 2026. We look forward to presenting data from our Phase 1 study later this year as well as preliminary data from the iMMagine-1 study in the second half of 2024. Additionally, we continue to expect commercial launch of CART-ddBCMA to be in 2026.”
Share:
More News
Thomas Guérinier, CEO and Co-founder of Inside Therapeutics: “The collaboration with OSE and MiNT provides us with a fantastic opportunity to demonstrate the uniqueness of our technology for the development of mRNA therapies from early development through to clinical trials and GMP production. The HexARN project fits perfectly with our
Thomas Mehrling, MD, PhD, CEO and Director of Helix, said “As co-founder of the Laevoroc companies, I’ve had the privilege of seeing LEUMUNA and GEMCEDA evolve from early scientific concepts into differentiated, first-in-class therapeutic candidates with real potential to transform cancer care. Their integration into Helix marks a strategic consolidation
“At Boundless, we’re committed to delivering innovative therapies for patients with oncogene-amplified cancers through disciplined execution,” said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. “By prioritizing the novel combination of BBI-355 and BBI-825, along with our exciting Kinesin program, BBI-940, we’re concentrating our resources where we see
“Most of the PMB-102 trial participants relapsed after CD19 CAR T therapy and/or presented with CD19 negative tumors. PMB-CT01 could present a viable alternative option for patients facing this challenging scenario,” said Hazel Cheng PhD., COO of PMB. “We are deeply committed to the development of this first-in-class BAFFR CAR