The US Food and Drug Administration (FDA) has lifted the partial hold from Arcellx’s Phase II trial investigating CART-ddBCMA in patients with relapsed or refractory multiple myeloma (rrMM).

The iMMagine-1 trial was put on partial hold by the agency on 19 June following the death of a patient. The patient was treated with the CAR-T cell therapy even though they became ineligible for the treatment under the trial protocol before the infusion.

As a result, the US-based biotech came to an agreement with the FDA regarding modifications to the trial protocol that would prevent and manage the risk of adverse events in the trial. Arcellx has retrained the trial sites to enhance protocol adherence.

The FDA also permitted an expansion of treatment options that patients are permitted to receive between bridging therapies, allowing the protocol to better align with the current clinical practice.

Arcellx CEO Rami Elghandour said: “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, minimising treatment disruption for patients and clinicians.”

Arcellx expects to present the topline data from the Phase II trial in the second half of 2024. The company also anticipates the commercial launch of CART-ddBCMA in 2026.

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In January, Arcellx announced a collaboration with Kite, a Gilead Company. Under the global strategic agreement, both companies are co-developing and co-commercialising CART-ddBCMA, with Arcellx commercialising in the US and Kite focusing on other global markets.

Pivotal Phase II trial

The iMMagine-1 trial (NCT05396885) is an open-label trial recruiting rrMM patients who were treated with at least three prior regimens. According to the registry, Arcellx plans to enrol 110 patients.

The primary endpoint of the trial is measuring the overall response rate with a time frame of 24 months. Long-term safety data will also be collected under a separate follow-up trial for up to 15 years as per the guidelines of health authorities.

CART-ddBCMA in earlier lines

Arcellx has previously shared with Clinical Trials Arena its plans to initiate a randomised Phase III study with CART-ddBCMA in second-line and third-line rrMM patients.

Arcellx CMO Christopher Heery noted that the iMMagine-2 trial design would be similar to other Phase III trials by Bristol Myers Squibb and Johnson & Johnson that are investigating their CAR-T therapies.

According to July’s corporate presentation, Arcellx plans to initiate the iMMagine-2 trial with CART-ddBCMA in the second half of 2023.

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