Frequently Asked Questions

Anbal-cel (anbalcabtagene autoleucel) is an autologous anti-CD19 CAR-T therapy that uses a 4-1BB/CD3ζ signaling backbone and incorporates dual shRNA-mediated downregulation of PD-1 and TIGIT (OVIS™ platform). The design aim is to reduce inhibitory signaling and help preserve effector and early-memory phenotypes under checkpoint pressure. It is not simply “another CD19 CAR-T”; the dual checkpoint knockdown is a defining functional layer. Clinical data are published in Blood (2026).

Biruni Cell Therapy (BCT) at Biruni Teknopark, Istanbul, manufactures the product under GMP following technology transfer from Curocell Inc. (South Korea). Clinical administration occurs at Biruni University Hospital.

The primary clinical evidence is in adults with relapsed or refractory large B-cell lymphoma after two or more prior systemic therapies. Additional programs are investigating B-ALL, CNS lymphoma, and severe refractory SLE/lupus nephritis. Suitability depends on diagnosis, prior treatments, disease tempo, organ function, infection status, and other factors assessed by the treating center. Only qualified physicians can determine eligibility.

Cytokine release syndrome (CRS), neurologic events, prolonged cytopenias, and infections are the principal categories of concern. In the Phase 2 safety population (n=79), any-grade CRS occurred in 57% (Grade 3: 8.9%; no Grade 4/5), any-grade neurologic events in 13.9% (Grade ≥3: 3.8%), and serious infections in 25.3%. Centers with CAR-T experience maintain specific monitoring and management protocols.

Local manufacturing at BCT targets a vein-to-vein interval of approximately 18–25 days (median around 20 days in described process improvements), including expansion and quality-release testing. Actual timing can vary with individual product kinetics and clinical readiness.

Anbal-cel received full regulatory approval from the Korean MFDS in April 2026 for specified adult r/r DLBCL/PMBCL indications. In Türkiye, local manufacturing has been established via technology transfer; clinical use is subject to TİTCK regulations, hospital protocols, and applicable authorization pathways (including treatment-purpose or other regulated routes). Patients and physicians should confirm the current regulatory status with Biruni University Hospital.

It is an educational review of the clinical information you submit, intended to help the Biruni team assess whether formal evaluation for CAR-T may be appropriate and to indicate possible next steps. It is not a diagnosis, treatment decision, or guarantee of access.

The educational second-opinion pathway is open to inquiries from outside Türkiye. Practical access depends on clinical appropriateness, regulatory pathways, logistics, and institutional capacity. Contact the team via the second-opinion form for orientation.

Key references include: Lee et al. Molecular Therapy 2022 (preclinical OVIS design); Kim et al. Blood 2026 (Phase 1/2 clinical report); Seo et al. Cancer Research and Treatment 2026 (MAIC vs tisagenlecleucel). ClinicalTrials.gov identifiers: NCT04836507, NCT07062627, NCT07364396.