"We are looking forward to sharing updated results from our ongoing studies evaluating GC012F in relapsed/refractory multiple myeloma and B-cell non-Hodgkin's lymphoma. We are particularly encouraged by the recognition of our long-term follow-up data of GC012F in RRMM, which will be presented at an oral session. We believe for these hematological cancers, there is critical need for transformational treatment options with strong efficacy, favorable safety profiles and rapid manufacturing," said Dr. Wendy Li, Gracell's Chief Medical Officer. "With plans to commence clinical trials in the U.S. and China following the receipt of regulatory clearance of Investigational New Drug applications, 2023 is a critical year for both GC012F and Gracell. We plan to showcase the latest data to our peers in cancer research at the ASCO Annual Meeting that augments the clinical validation of the FasTCAR platform in a wide array of indications, emphasizing the importance of the dual-targeted approach and the potential benefits of enhanced T cell quality and accelerated delivery of the therapy to patients thanks to Gracell's FasTCAR next-day manufacturing technology."

BCMA/CD19 Dual-Targeting FasTCAR-T GC012F for the Treatment of RRMM

Longer-term follow-up data from a multicenter investigator-initiated trial evaluating GC012F for the treatment of RRMM in heavily pretreated patients will be presented as an oral abstract session.

Oral presentation details are as follows:

• Abstract title: Updated results of a phase I, open-label study of BCMA/CD19 dual-targeting fast CAR-T GC012F for patients with relapsed/refractory multiple myeloma (RRMM) 
• Abstract number: 8005
• Session title: Hematologic Malignancies – Plasma Cell Dyscrasia
• Session type: Oral Abstract Session
• Presentation time: Saturday, June 3 at 1:15 PM – 4:15 PM CDT

BCMA/CD19 Dual-Targeting FasTCAR-T GC012F for the Treatment of B-NHL

A separate poster presentation will highlight updated clinical results from an ongoing IIT evaluating GC012F for the treatment of relapsed/refractory B-NHL. While CD19-directed CAR-T has proven effective for the treatment of NHL^[i],[ii], the CD19/BCMA dual-targeting approach is novel for this indication. Additionally, this study further validates the FasTCAR platform.

Poster presentation details are as follows:

Abstract title: Updated clinical results of first-in-human study of CD19/BCMA dual-targeting fast CAR-T GC012F for patients with relapsed/refractory B-cell non-Hodgkin's lymphoma

• Abstract number: 7562
• Session title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
• Session type: Poster Abstract Session
• Session date & time: Monday, June 5 at 8:00 – 11:00 AM CDT