Our Pipeline
Our pipeline is growing and ambitious. Our lead asset, anitocabtagene autoleucel (anito-cel), is currently in a Phase 2 pivotal trial for patients with relapsed or refractory multiple myeloma.
Our Current Pipeline
Multiple Myeloma
iMMagine-1 (NCT05396885) is a Phase 2, open-label study evaluating the efficacy and safety of anitocabtagene autoleucel (formerly CART-ddBCMA) in patients with relapsed or refractory multiple myeloma who have received at least 3 prior regimens of systemic therapy including a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
iMMagine-3 is a global, Phase 3, randomized, open-label study evaluating the safety and efficacy of anitocabtagene autoleucel (formerly CART-ddBCMA) in patients with relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy and have been previously exposed to both an immunomodulatory drug (IMiD) and an anti-CD38 antibody.
ACLX-001 is in development for the treatment of relapsed or refractory multiple myeloma. ACLX-001 is composed of ARC-T cells and a bivalent SparX protein-targeting BCMA. This SparX-BCMA protein utilizes the same antigen binding domain as anitocabtagene autoleucel.
Acute Myeloid Leukemia
ACLX-002 is an ARC-SparX platform cell therapy using a SparX protein targeting CD123 for the treatment of relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
Arcellx has also identified a second antigen target associated with AML/MDS. This program is in advanced preclinical development.
Arcellx has also identified a third antigen target associated with AML/MDS. This program is in advanced preclinical development.
Non-Oncology
Arcellx has initiated a Phase 1, open-label study evaluating the efficacy and safety of anitocabtagene autoleucel (formerly CART-ddBCMA) in patients with Generalized Myasthenia Gravis.
Solid Tumors
Arcellx intends to develop multiple assets and novel technology to combat a variety of solid tumor indications while leveraging the strengths of each of our existing ddCAR and ARC-SparX therapeutic platforms. We anticipate our initial targets will be in hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC).
Arcellx intends to develop multiple assets and novel technology to combat a variety of solid tumor indications while leveraging the strengths of each of our existing ddCAR and ARC-SparX therapeutic platforms. We anticipate our initial targets will be in hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC).
Certain technologies, agents, and/or uses described above are investigational. Their safety and efficacy have not been established, and they have not been approved by the US Food and Drug Administration or other regulatory authorities. There is no guarantee that Kite will commercialize these technologies, agents, and/or uses.
Therapeutic Focus Areas
Arcellx is focused on the development of cell therapies in cancers with a particularly high need. We are developing cell therapy treatments for multiple myeloma, acute myeloid leukemia, myelodysplastic syndrome, and solid tumors.
Patients and their loved ones can find additional information here.
Multiple myeloma (MM) is a blood cancer that may cause cancerous tumors in bone and soft tissue. Multiple myeloma is the third most common hematological malignancy in the United States and Europe. Despite the development and use of multiple new therapies, the 5-year survival rate is approximately 50% as multiple myeloma remains incurable in most patients.
Acute myeloid leukemia (AML) is a blood and bone cancer that arises from bone marrow stem cells that have accumulated genetic mutations, causing the mutated cells to grow uncontrollably. CAR-T therapies are being deployed with specificity for various targets including CD33, CD123, FLT3, CCL1, CD19, IL1RAP, and NKG2DL. The 5-year survival rate for acute myeloid leukemia patients is approximately 29%.
Myelodysplastic syndrome (MDS) is a disease closely related to AML in which a population of abnormal myeloid stem cells develops in the bone marrow. Like AML, MDS impacts the elderly, with patients often diagnosed in their 70s. An estimated one-third of MDS patients progress to AML. Patients are typically treated with chemotherapy. While stem cell transplant may cure MDS, toxicities associated with the treatment significantly limit patient eligibility.
Generalized Myasthenia Gravis (gMG) is a rare autoimmune disease characterized by severe muscle weakness. In gMG, the body’s immune system mistakenly attacks proteins in the neuromuscular junction, disrupting neuromuscular signaling and preventing muscle contraction. Symptoms include muscle weakness, drooping eyelids, impaired chewing, swallowing, and speaking. gMG affects over 70,000 people in the United States and there is no known cure.
Arcellx intends to develop multiple assets and novel technology to combat a variety of solid tumor indications while leveraging the strengths of each of our existing ddCAR and ARC-SparX therapeutic platforms. We anticipate our initial targets will be in hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC).