On May 9, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported the publication of clinical data from its dose escalation cohorts in its ongoing Phase 1 study of CART-ddBCMA for the treatment of patients with relapsed or refractory multiple myeloma (r/r MM) (Press release, Arcellx, MAY 9, 2022, View Source [SID1234613971]). The data were published in Blood Advances, the open-access journal of the American Society of Hematology (ASH) (Free ASH Whitepaper).

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The publication entitled, "Phase 1 Study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma," reported the following:

Twelve patients in the dose escalation cohorts received a single dose of either 100×106 CART-ddBCMA (DL1, n=6) or 300×106 CART-ddBCMA (DL2, n=6) following a standard lymphodepletion regimen.
No cases of Grade 3 or higher CRS or ICANS occurred at DL1, the recommended Phase 2 dose.
No Parkinsonian-like movement disorders or atypical neurological toxicities were observed.
The maximally tolerated dose was not reached.
All patients dosed responded to CART-ddBCMA (ORR 100%) and 9/12 (75%) patients achieved CR/sCR.
Responses deepened over time and at the data cut (November 4, 2021; median follow-up 56 weeks), 7/9 (78%) of evaluable patients achieved minimal residual disease negativity at 10-5 or greater.
These findings demonstrate the potential safety of CART-ddBCMA cells and durable responses to CART-ddBCMA in r/r MM patients.
The full online publication can be accessed here.

"We are honored to have the clinical results of the first 12 patients treated in the dose escalation cohorts with CART-ddBCMA published in a prominent hematologic journal," said Rami Elghandour, Arcellx’s chairman and chief executive officer. "Given these initial results, we expanded our Phase 1 study at our intended Phase 2 pivotal study dose of 100 million cells, and believe these data are indicative of the potential for CART-ddBCMA to be a best-in-class treatment option for patients with multiple myeloma. We look forward to presenting new clinical data at ASCO (Free ASCO Whitepaper) on June 5 and initiating our Phase 2 pivotal study for CART-ddBCMA in the second half of this year."

About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About CART-ddBCMA
CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain for the treatment of patients with relapsed or refractory multiple myeloma. CART-ddBCMA is currently in a Phase 1 study. Arcellx’s proprietary binding domains are novel synthetic proteins designed to bind specific therapeutic targets. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.