Clinical Hold Announced for Arcellx’s IMMagine-1 Phase 2 Clinical Program

The biotechnology company Arcellx has announced that the phase 2 clinical program for their multiple myeloma cell therapy candidate iMMagine-1 has been placed on hold following a notification from the U.S. Food and Drug Administration (FDA). 

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Hold on IMMagine-1 Phase 2 Clinical Program 

On June 19, Arcellx issued a press release stating that a clinical hold had been placed on iMMagine-1, a drug for the treatment of refractory myeloma (rrMM). The FDA’s notification was received on June 16 in the wake of a patient’s death. Despite this, they have been provided with clearance to continue the dosing of patients who have undergone lymphodepletion. Arcellx believes a contributing factor to the event is the limitations of bridging therapy. Bridging therapy is the treatment between the collection of T cells and lymphodepletion. 

The company has affirmed that their priority remains patients’ safety and well-being. Rami Elghandour,  Arcellx’s Chairman and Chief Executive Officer, commented, “In coordination with our investigators, data safety monitoring board (DSMB), and our partners at Kite Pharma, we are working with FDA to address the clinical hold. The expansion of bridging therapy regimens is consistent with what’s currently available in clinical practice and is in the best interest of patients. Additionally, we continue to evaluate other potential improvements to the study. We remain confident that CART-ddBCMA is a potential best-in-class therapy for the treatment of patients with rrMM based on the clinical profile observed in the patients dosed to date across our studies. The drug product release characteristics from iMMagine-1 are consistent with those from our Phase 1 study. The manufacturing success rate remains 100% while ramping Lonza, our cell therapy manufacturer, to full scale. Fourteen clinical sites have been opened and study enrollment is tracking to our expectations. We look forward to resolving this matter expeditiously and to continue to advance our therapy to the benefit of patients suffering from rrMM.” 

CAR-T cell Treatment in Multiple Myeloma

Multiple myeloma is a hematological cancer that generally affects the skull, pelvis, ribs, and spine. This type of bone marrow cancer affects blood cell production and causes damage to the patient’s bones.  It is a relatively uncommon cancer that accounts for about 10% of all  hematological cancers and around 2% of all cancer deaths in the US. Although the cause of multiple myeloma is yet unknown, it can be linked to the non-malignant condition multiple monoclonal gammopathy of undetermined significance (MGUS). MGUS can often develop into multiple myeloma. This happens because in both conditions there is an abnormal production of M proteins by plasma cells.

IMMagine-1 is a CAR T-cell therapy drug candidate for the treatment of multiple myeloma. CAR T-cell therapy is a form of immunotherapy that uses genetically modified T cells to target cancer cells. These therapies fight cancer by using our body’s own immune system and are customized to each individual. Typically, a patient’s T cells are collected and engineered to produce chimeric antigen receptors (CARs). CARs are able to bind to antigens or proteins on cancer cells that normal T cells can’t recognize as atypical. In the case of Arcellx’s iMMagine-1, the T cells have been engineered to kill cells that express an antigen for multiple myeloma.

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GeneOnline Team