NEW YORK – The US Food and Drug Administration has lifted a partial hold on a Phase II trial testing Arcellx's CART-ddBCMA in patients with relapsed or refractory multiple myeloma, the company said Monday while reporting its second quarter financial performance.
The FDA placed a partial hold on the CART-ddBCMA program in June after a patient died in the IMMagine-1 trial. The Redwood City, California-based company attributed the death to limitations on bridging therapies that patients were allowed to receive between apheresis and CAR T-cell infusion. The FDA gave clearance at the time to continue dosing patients who had undergone lymphodepletion.
After reviewing what went wrong in the trial, Arcellx has now updated the IMMagine-1 protocol and, with the FDA's permission, expanded the bridging therapies patients can receive.
"As a key step to enhancing protocol adherence related to the prevention and management of the risk of adverse events, we retrained clinical sites," Arcellx Chairman and CEO Rami Elghandour noted in a statement. "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."
CART-ddBCMA is a BCMA-specific CAR-modified T-cell therapy, which Arcellx is developing in partnership with Gilead Sciences subsidiary Kite Pharma. In IMMagine-1, Arcellx is evaluating patients' overall response rate, depth of disease response, duration of response, and overall survival on the treatment, as well as the cell therapy's safety.
Arcellx doesn't have any marketed therapies. In the second quarter of 2023, the company reported collaboration revenue of $14.3 million from its arrangement with Kite Pharma for CART-ddBCMA; Arcellx had no revenues in the year-ago quarter. The firm reported a net loss of $23.9 million in Q2 2023, or $.50 per share, compared to a net loss of $30.8 million in Q2 2022, or $.84 per share. As of June 30, the company had $506.5 million in cash, cash equivalents, and marketable securities, which Arcellx estimates will fund its operations into 2026.
In afternoon trading on the Nasdaq, Arcellx's stock price was up more than 6 percent at $35.74.