News
December 05, 2025
AvenCell Therapeutics Announces IND Clearance and EMA Approval of Clinical Trial Application (CTA) for the QUADvance Study, a Phase I/II trial evaluating AVC-203, a Novel Allogeneic CD19/CD20 CAR-T Investigational Therapy for the Treatment of Relapsed/Ref
CAMBRIDGE, Mass., Dec. 4, 2025 /PRNewswire/ -- AvenCell Therapeutics, Inc., a leading clinical-stage cell therapy company focused on advancing both switchable and allogeneic CAR-T cell therapies, today announced that the FDA and the European Medicines Agency (EMA) have cleared the...
AvenCell Therapeutics, a company specializing in cell therapy, has received the green light from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to proceed with a clinical trial for its innovative cancer treatment, AVC-203. This marks a significant milestone for the company and offers hope for patients battling relapsed or refractory B-cell malignancies.
The upcoming study, dubbed QUADvance, is a Phase I/II clinical trial designed to evaluate the safety and effectiveness of AVC-203. This novel therapy is an allogeneic CAR-T, or Chimeric Antigen Receptor T-cell, therapy. CAR-T therapy involves modifying a patient's own immune cells to recognize and attack cancer cells. However, AVC-203 takes a different approach by utilizing allogeneic cells, meaning the T-cells are sourced from a healthy donor rather than the patient themselves. This "off-the-shelf" approach offers several potential advantages, including faster treatment availability and reduced manufacturing complexities.
AVC-203 is designed to target both CD19 and CD20, two proteins commonly found on the surface of B-cells. By targeting both proteins, AvenCell hopes to improve the therapy's ability to eliminate cancerous B-cells, even if some cells only express one of the two targets. This dual-targeting strategy aims to overcome potential resistance mechanisms and improve long-term outcomes for patients.
Relapsed or refractory B-cell malignancies are cancers that have either returned after initial treatment or have stopped responding to treatment. These cancers can be particularly challenging to treat, and new therapeutic options are urgently needed. The QUADvance study will enroll patients with these difficult-to-treat cancers to assess the safety and efficacy of AVC-203.
AvenCell Therapeutics is focused on developing both switchable and allogeneic CAR-T cell therapies. This IND clearance and CTA approval for the QUADvance study are major steps forward in the company's mission to advance the field of cell therapy and provide innovative treatment options for patients with cancer. The initiation of the QUADvance trial represents a promising development in the fight against B-cell malignancies and a testament to AvenCell's commitment to pioneering cutting-edge cell therapies.
The upcoming study, dubbed QUADvance, is a Phase I/II clinical trial designed to evaluate the safety and effectiveness of AVC-203. This novel therapy is an allogeneic CAR-T, or Chimeric Antigen Receptor T-cell, therapy. CAR-T therapy involves modifying a patient's own immune cells to recognize and attack cancer cells. However, AVC-203 takes a different approach by utilizing allogeneic cells, meaning the T-cells are sourced from a healthy donor rather than the patient themselves. This "off-the-shelf" approach offers several potential advantages, including faster treatment availability and reduced manufacturing complexities.
AVC-203 is designed to target both CD19 and CD20, two proteins commonly found on the surface of B-cells. By targeting both proteins, AvenCell hopes to improve the therapy's ability to eliminate cancerous B-cells, even if some cells only express one of the two targets. This dual-targeting strategy aims to overcome potential resistance mechanisms and improve long-term outcomes for patients.
Relapsed or refractory B-cell malignancies are cancers that have either returned after initial treatment or have stopped responding to treatment. These cancers can be particularly challenging to treat, and new therapeutic options are urgently needed. The QUADvance study will enroll patients with these difficult-to-treat cancers to assess the safety and efficacy of AVC-203.
AvenCell Therapeutics is focused on developing both switchable and allogeneic CAR-T cell therapies. This IND clearance and CTA approval for the QUADvance study are major steps forward in the company's mission to advance the field of cell therapy and provide innovative treatment options for patients with cancer. The initiation of the QUADvance trial represents a promising development in the fight against B-cell malignancies and a testament to AvenCell's commitment to pioneering cutting-edge cell therapies.
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