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On September 23, senlangbio and Professor Lu Peihua's team from Hebei Yanda Lu Daopei Hospital published a research paper titled "Analysis of 60 patients with relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma treated with CD7-targeted chimeric antigen receptor-T cell therapy" in the international authoritative journal American Journal of Hematology (IF=12.8). This study, based on natural selection anti-CD7 chimeric antigen receptor T-cell therapy, achieved a series of encouraging results, bringing new hope to both patients and the medical community.
Senlangbio has developed a patient or donor-derived "Naturally Selected" CD7 CAR-T cell (NS7CAR-T) product that does not require additional CD7 gene editing or protein expression blocking. In this Phase I/II clinical trial, a total of 65 pediatric and adult patients participated in the treatment of R/R T-cell acute lymphoblastic leukemia and lymphoma (T-ALL/LBL) (NCT04572308 and NCT04916860). Among them, 60 patients (35 with T-ALL and 25 with T-LBL) received a single dose of NS7CAR-T cell infusion.Highlights of Clinical TrialsDeep Complete Bone Marrow Remission: After 28 days of treatment, 94.4% of patients achieved deep complete bone marrow remission, offering prolonged disease control and survival opportunities.Active Response in Extramedullary Lesions: Among 32 patients with extramedullary lesions, 78.1% responded to treatment, with 56.3% achieving complete remission and 21.9% achieving partial remission.Long-term survival chances: The 2-year overall survival rate was 63.5%, and the 2-year progression-free survival rate was 53.7%, indicating that the NS7CAR-T therapy is not only effective but also has strong durability, with no significant difference between pediatric and adult patients.At the Day 28 efficacy evaluation, 94.4% (51/54) of the 54 patients with bone marrow involvement achieved complete remission (CR) and deep remission with minimal residual disease (MRD)-negative status. Six T-LBL patients without bone marrow involvement at enrollment remained MRD-negative. Among 32 patients with extramedullary lesions, the overall response rate (ORR) after NS7CAR-T treatment was 78.1%, including 18 (56.3%) patients with complete remission (CR) and 7 (21.9%) patients with partial remission (PR). Among six patients with bulky lesions (>7 cm), four responded to the treatment, with three achieving CR and one achieving PR, while the other two patients showed no response or stable disease.
The survival data of patients were collected until March 31, 2023, with a median follow-up time of 368.5 days (range: 23-833 days). The overall survival rates at 1 year and 2 years were 72.7% (95% CI 60.8-84.6) and 63.5% (95% CI 47.7-79.4), respectively. The corresponding progression-free survival rates at 1 year and 2 years were 58.6% (95% CI 45.9-71.3) and 53.7% (95% CI 38.9-68.6), respectively. There was no significant difference in either overall survival or progression-free survival between patients aged 14 years or younger and those older than 14 years. Additionally, the dose of NS7CAR-T cells had no significant impact on survival rates.Among 60 patients, 48 (80.0%) developed mild cytokine release syndrome (CRS), including 42 cases (70.0%) of grade 1 CRS and 6 cases (10.0%) of grade 2 CRS. Six patients (10%) experienced grade 3 CRS, and one patient (1.7%) developed grade 4 CRS. Only three patients experienced neurotoxicity events (ICANS), with two patients (3.3%) developing grade 1 ICANS and one patient (1.7%) experiencing grade 4 ICANS. Overall, the safety profile was reliable.In summary, this study demonstrates that CD7-targeted immunotherapy may become a viable treatment option for relapsed and refractory T-cell malignancies. Our NS7CAR-T therapy has shown significant efficacy in treating patients with relapsed and refractory T-cell malignancies, presenting encouraging 1-year and 2-year treatment outcomes while maintaining controllable safety. With limited treatment options and very poor prognosis for these patients, the NS7CAR-T therapy brings new hope.
Senlangbio was founded in January 2016 and is located in the Shijiazhuang International Biomedical Industry Park. It is a high-tech biomedical enterprise that focuses on the research, development, and application of innovative immunotherapy drugs.Currently, Senlangbio has built an efficient cell therapy innovation technology platform. On this platform, it has developed and produced several leading products, including novel CD19-targeted CAR-T, CD7-targeted CAR-T, Combo CAR-T, universal CAR-γδT, and multiple therapies targeting solid tumors. These products are used for treating major hematological malignancies such as acute lymphoblastic leukemia and lymphoma, as well as solid tumors like liver cancer.
R&D Pipeline
Reference: Zhang X, Yang J, Li J, Qiu L, Zhang J, Lu Y, Zhao YL, Jin D, Li J, Lu P. Analysis of 60 patients with relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma treated with CD7-targeted chimeric antigen receptor-T cell therapy. Am J Hematol. 2023 Sep 23. doi: 10.1002/ajh.27094. Epub ahead of print. PMID: 37740926.
