AbelZeta Secures IND Clearance for C-CAR039 in Relapsed or Refractory Large B-Cell Lymphoma

AbelZeta Pharma has received U.S. Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application for C-CAR039, also known as prizloncabtagene autoleucel (Prizlon-cel), an anti-CD20/CD19 bispecific CAR-T therapy for patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL).

The regulatory milestone brings C-CAR039 into U.S. clinical development as AbelZeta prepares studies in patients with substantial unmet need, including those whose disease has progressed after commercially available CAR-T therapies.

Bispecific CAR-T Targets CD20 and CD19

C-CAR039 is an autologous CAR-T therapy engineered to recognize two B-cell antigens, CD20 and CD19. Targeting both antigens may provide broader tumor-cell recognition and address disease heterogeneity and antigen loss that can contribute to resistance to single-antigen CAR-T therapies.

LBCL remains a major treatment challenge for patients who relapse or become refractory after cellular therapy. Although CD19-directed CAR-T therapies have transformed treatment for aggressive B-cell malignancies, a proportion of patients experience disease progression after treatment, leaving limited therapeutic options.

Long-Term Data Support Further Development

The U.S. program is supported by clinical data from early trials conducted in China. At the European Society for Blood and Marrow Transplantation (EBMT) meeting in March 2026, AbelZeta presented long-term results from 48 patients with r/r B-cell non-Hodgkin lymphoma treated with C-CAR039.

The therapy produced an overall response rate of 91.5%, with complete responses in 85.1% of patients. At a median follow-up of 53.9 months, median progression-free survival reached 60.1 months. The company reported a favorable safety profile alongside the depth and durability of responses.

These findings provide the clinical rationale for evaluating C-CAR039 in patients who have fewer treatment options following prior cellular therapy.

U.S. Development Program Expands

In July 2026, AbelZeta regained all development, regulatory, manufacturing, commercialization, out-licensing and other collaboration rights for C-CAR039. The company is now working with the FDA to finalize clinical protocols covering multiple treatment settings.

Planned U.S. development will include third- or later-line LBCL patients previously treated with CAR-T therapy, as well as second-line patients who have not previously received CAR-T therapy.

“We believe that it has potential to help patients who have been treated and relapsed with commercially approved CAR-T therapies,” Tony (Bizuo) Liu, chairman and CEO of AbelZeta, said, highlighting the company’s focus on post-CAR-T relapse while also pointing to earlier-line development.

China Phase II Trial Remains Ongoing

The registrational Phase II trial of C-CAR039 in China continues to evaluate the therapy in r/r LBCL patients who are CAR-T therapy naïve. Results from this study will provide additional evidence as AbelZeta advances the program across treatment lines and geographic markets.

The FDA IND clearance therefore marks an important step toward establishing whether the dual-targeting approach can extend the clinical benefit of CAR-T therapy to patients with relapsed LBCL, including those whose disease has progressed after prior CAR-T treatment.

Reference

AbelZeta Regains Global Rights of C-CAR039 (Prizlon-cel) and Receives FDA Clearance of IND Application in Large B-cell Lymphoma – AbelZeta Pharma