RD13-02 is a universal CAR-T cell product targeting CD7 derived from healthy donors, and intended for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma(T-ALL/LBL). It is genetically modified to avoid fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG) while enhancing anti-tumor activity. RD13-02 can be prepared in a single batch for multiple people, achieving an “off-the-shelf” capability for patients in need of CAR-T cell therapy.
November 7, 2024, Bioheng Therapeutics announced that it will present the latest Phase I clinical data of its universal CAR-T cell product RD13-02, targeting CD7 for the treatment of relapsed/refractory(R/R) T-ALL/LBL patients, in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting. The conference will take place from December 7-10, 2024, in San Diego, USA.
Results: As of August 1, 2024, a total of 18 eligible pts with R/R T-ALL/LBL were enrolled (13 ALL, 5 LBL), with a median age of 33.5 years (range, 11 to 67). The median prior lines of therapy were 2 (range, 1 to 5), and 4 pts had prior allo-HSCT before enrollment. The median proportion of BM blasts was 71% (range: 6% to 90%) among 18 pts, with 9 (6 ALL, 3 LBL) showing extramedullary involvement. No dose-limiting toxicity (DLT) event or neurotoxicity was observed at all dose levels, with only one case of Gr1 GvHD occurring. Cytokine release syndrome (CRS) was manageable with the majority being mild (Gr1, n=10; Gr2, n=5; Gr3, n=3). Any-grade infections occurred in 13 (72%) pts (≥Gr3 in 2 [11%] pts). Due to the occurrence of Gr3 CRS in one pt each from DL2 and DL3 levels, investigators set the DL1 as expansion dose with a paramount focus on safety and efficacy. During the dose expansion, one pt died from tumor lysis syndrome on Day 20 post infusion.
At the initial 28-day assessment post-infusion, 14 out of 17 evaluable pts achieved CR/CRi. While by the 2nd month post-infusion, two more pts reached CR/CRi, with CR/CRi rate of 94%(16/17). Among pts with CR/CRi, 100% achieved minimal residual disease (MRD) negative status by flow cytometry analysis. The median Cmax of CAR-T cells in the peripheral blood was 1,863,601 copies/μg genomic DNA (range, 275,044 to 3,763,587) by qPCR, with the longest duration exceeding 90 days.
Conclusion: RD13-02, an “off-the-shelf” universal CAR-T product, showed a manageable safety profile and enhanced efficacy in treating R/R CD7 T-ALL/LBL. Notably, 100% of CR/CRi pts achieved MRD-negative status, offering pts more prompt treatment options.
At present, there are many other CAR-T clinical trials in China, and they are looking for patients. For consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
References
1.https://www.bioheng.com/News_Details/26.html
2.https://ash.confex.com/ash/2024/webprogram/Paper207322.html
3.http://myimm.net/mianyizhiliao/2035.html
Post time: Dec-03-2024