SENL101 / SenlangBio - LARVOL DELTA

Binding of the elastin peptide VGVAPG and lactose to the human elastin binding protein. (PubMed, J Struct Biol) - "Molecular docking of VGVAPG (as a representative EDP) and lactose (as a representative galactosugar) followed by MD simulations, allowed us to identify key binding residues: D98, E99, S104, and S136 for VGVAPG; and E99, S101, S104, N116, Q124, E137, and Y139 for lactose...Furthermore, EBP residues P233 and I234 were implicated in potential interactions with PPCA or NEU-1, contributing to ERC assembly. These findings offer new insights into the molecular recognition mechanisms of EBP and provide a foundation for the design of EBP-targeted elastin peptide antagonists."

Journal

Development and Application of KASP Markers for Candidate Glucosinolate Biosynthesis Genes in Broccoli. (PubMed, Int J Mol Sci) - "Among the tested markers, S101, located in AOP2, exhibited consistent genotype-dependent effects on GNA and PRO across both populations, supporting its stable predictive value...Although association signals were reduced under mixed linear model (MLM) analysis with false discovery rate (FDR) correction, major loci identified under the general linear model (GLM) framework remained detectable. Overall, these results demonstrate the potential of candidate gene-based KASP markers for improving aliphatic GSL composition in broccoli through marker-assisted selection."

Journal

CD7-TARGETED CHIMERIC ANTIGEN RECEPTOR (CAR)-T CELL THERAPY SHOWS GOOD EFFICACY AND SAFETY IN REFRACTORY/RELAPSED MIXED PHENOTYPE ACUTE LEUKEMIA (MPAL) (EBMT 2026) - P=N/A | "Before CAR-T cell infusion, patients received bridging chemotherapy to control rapid disease progression, followed by a lymphodepleting regimen of fludarabine (30 mg/m2/d) and cyclophosphamide (300 mg/m2/d) for three days (day -5 to day -3). This study demonstrates that NS7CAR-T cells are a promising therapeutic option for CD7-positive MPAL, including patients who relapsed after transplantation. Consolidative allo-HSCT further improves survival outcomes. Further studies with longer follow-up and larger cohorts are warranted to confirm the long-term efficacy and durability of NS7CAR-T therapy in MPAL."

Clinical • IO biomarker • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • CD7

CD7-targeted CAR-T cell therapy showed a high efficacy for 30 patients with relapsed or refractory central nervous system T-cell lymphoblastic leukemia/lymphoma (ASH 2025) - P=N/A, P1 | "All patientsreceived intravenous fludarabine (30mg/m2/d) and cyclophosphamide (300mg/m2/d) (FC) conditioningregimens on day -5 to day -3 prior to NS7 CAR-T infusion. We identified STIL::TAL1 fusion as a potential predictor of early relapse. Further studieswith extended follow-up and larger cohorts are warranted to better define the long-term efficacy anddurability of NS7CAR-T therapy in CNS-involved T-ALL/LBL."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoma • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD7 • TAL1 • TP53

Recently, the core product of Hebei Senlang Biotechnology Co., Ltd., "CAR-T cell product targeting CD7 (SENL101 autologous T cell injection)," has been included in the CDE Breakthrough Therapy Program based on its excellent clinical data and significant therapeutic potential. (Senlang Biotech Press Release) - "The proposed indication is adult relapsed or refractory T-lymphoblastic lymphoma/leukemia (T-LBL/ALL)....In the Phase I clinical ARMA-I study, the overall ORR was as high as 87.5% (14/16), with 62.5% (10/16) of patients achieving CR/CRi. Regarding safety, 87.5% (14/16) of the subjects experienced minor CRS, but the vast majority were grade 1 or 2, and no ICANS events occurred....Currently, a pivotal Phase II clinical trial supporting the market launch of SENL101 autologous T-cell injection has been initiated."

Breakthrough therapy • T Acute Lymphoblastic Leukemia • T Lymphoblastic Lymphoma

Discovery of N-Ethyl Sulfonamide Derivatives as Potent Intestinal-Restricted Farnesoid X Receptor Antagonists for the Treatment of Metabolic Disorders. (PubMed, J Med Chem) - "Mechanistically, F44-S101 selectively antagonizes intestinal FXR and feedback-activates hepatic FXR, thereby promoting cholesterol metabolism and reducing lipid accumulation. Collectively, these findings highlight F44-S101 as a promising lead compound for hyperlipidemia and support intestinal FXR antagonism as a potential therapeutic strategy for metabolic disorders."

Journal • Dyslipidemia • Metabolic Disorders

Nanobody-based Naturally Selected CD7-Targeted CAR-T Therapy for Acute Myeloid Leukemia. (PubMed, Blood) - P=N/A | "This trial underscores the potential promising treatment of dVHH NS7CAR-T in providing clinical benefits with a manageable safety profile to CD7-positive AML patients, warranting further investigation. NCT04938115."

Journal • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD7

Naturally Selected CD7 CAR-T Therapy without Genetic Manipulations for T-ALL/LBL: First-in-human Phase I Clinical Trial. (PubMed, Blood) - P1 | "More patients and longer follow-up are needed for validation. Clinical Trial can be found at NCT04572308, https://clinicaltrials.gov/."

IO biomarker • Journal • P1 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Inflammation • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • CD7 • CD8

CARMA-1: The phase I Study of SENL101, a naturally selected nanobody based CD7 CAR-T therapy, in relapsed or refractory T-ALL/lbl (ASH 2025) - P1 | "Enrolled subjects receivedlymphodepleting chemotherapy (fludarabine 30mg/m2/day and cyclophosphamide 300mg/m2/day for 3days) followed by a single infusion of SENL 101...All CRS events were rapidly relieved after conventional CRS intervention, including tocilizumab andsteroids...SENL101 demonstrated a manageablesafety profile and encouraging anti-leukemic activity in subjects with R/R T-ALL/LBL. A Phase II study iscurrently being initiated."

P1 data • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Lymphoma • T Acute Lymphoblastic Leukemia • CD7

CD7 CAR-T cell therapy based on "Natural Selection" for the treatment of Relapsed or Refractory CD7-positive Hematologic Malignancies: A large cohort study (ASH 2025) - P=N/A, P1 | "ConclusionsThis large pooled cohort analysis demonstrates that NS7CAR-T therapy exhibits very promising clinicallyefficacy, achieving an 84.5% CR rate, along with a manageable safety profile in patients with R/R CD7-positive hematologic malignancies, including T-ALL/LBL, AML, MPAL and PTCL. While a small subset ofpatients experienced grade ≥3 CRS and ICANS, the robust response rates and survival outcomes positionNS7CAR-T as a potentially transformative treatment option for R/R CD7-positive hematologicmalignancies, including post-transplant relapsed patients."

CAR T-Cell Therapy • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoblastic Lymphoma • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • T-cell Acute Lymphoblastic Lymphoma • CD7

Big Announcement | Senlang Biotechnology’s 6 Cutting-Edge Achievements to be Showcased at ASH2025 [Google translation] (Senlang Biotech Press Release) - "The company will officially release six of its latest clinical research findings during the conference, including its core products: CD7-targeted SENL101, CD19/BCMA dual-targeted SL1703, CD19/CD20 dual-targeted SL1716, and BCMA/GPRC5D dual-targeted SL0439."

Clinical data • Multiple Myeloma • Non-Hodgkin’s Lymphoma

Recently, Senlan Bio, a leading Chinese innovator in CAR-T cell therapy, announced that it will be presenting at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, USA, from December 6th to 9th, 2025. [Google translation] (Senlang Biotech Press Release) - "Among them, the CD7-targeting CAR-T cell therapy SENL101 showed promising results in the Phase I clinical trial (CARMA-I study) for the treatment of relapsed/refractory T-ALL/LBL patients, demonstrating excellent efficacy and a safety profile that is clinically superior to similar products. In 16 subjects who received cell infusion, the overall objective response rate (ORR) was as high as 87.5% (14/16), with 62.5% (10/16) achieving complete remission (CR)/critical response (CRi)."

P1 data • T Lymphoblastic Lymphoma • T-cell Acute Lymphoblastic Lymphoma

Phase II Trial of S101 Autologous Anti-CD7 CAR-T Cells in Patients With R/R T-LBL/ALL. (clinicaltrials.gov) - P2 | N=38 | Not yet recruiting | Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

New P2 trial • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase 1 Dose Escalation Study of the Anti-CD7 CAR-T Therapy in Relapsed/Refractory T-Cell Acute Leukemia and Lymphoblastic Lymphoma (ASH 2023) - "SENL101 expanded robustly but persisted shortly, which on the other hand, contributed to the recovery of CD7 + T and NK cells, thereby reducing the risk of infection. An expanded cohort is warranted to verify the long-term benefit of SENL101 for T-cell malignant patients."

P1 data • Anorexia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Leukopenia • Lymphoma • Oncology • Septic Shock • T Acute Lymphoblastic Leukemia • Thrombocytopenia • Transplantation • CD4 • CD8

A Parallel Comparison of the Safety and Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation for Refractory and Relapsed T-ALL/Lbl Patients Who Achieved Complete Remission with CD7 CAR-T Versus Patients Who Achieved First Complete Remission with Chemotherapy before Transplantation (ASH 2023) - P=N/A, P1 | "Patients who met the following criteria were included in this parallel study: 1) underwent the first allo-HSCT in our hospital, 2) achieved CR before transplantation either from NS7CAR-T therapy or CR1 from chemotherapy (Fig...We used total body irradiation (TBI)-based conditioning regimens (n=128) or Busulfan/Melphalan-based regimens (n=11). To prevent graft-versus-host disease (GVHD), we used ATG along with a short-term regimen combining methotrexate, cyclosporine/tacrolimus, and mycophenolate mofetil...Conclusions Our parallel study showed that T-ALL/LBL patients, who achieved CR via CD7 CAR-T therapy followed by a consolidation allo-HSCT, had similar favorable OS and LFS compared to patients who underwent allo-HSCT in the CR1 state induced by chemotherapy. This was achieved without increasing the incidence of GVHD, infections, or TA-TMA."

Clinical • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Gene Therapies • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • Transplantation • CD7

Naturally Selected CD7-Targeted Chimeric Antigen Receptor (CAR)-T Cell Therapy for Refractory/Relapsed Acute Myeloid Leukemia: Phase I Clinical Trial (ASH 2023) - P=N/A | "All patients received intravenous fludarabine (30mg/m2/d) and cyclophosphamide (300mg/m2/d) lymphodepletion chemotherapy for three consecutive days (Day -5 to Day -3). The safety profile of NS7CAR-T therapy was manageable. However, to comprehensively assess the efficacy of NS7CAR-T in treating CD7-positive AML, further data from a larger cohort of patients and longer follow-up time are essential."

Clinical • IO biomarker • P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • Respiratory Diseases • Transplantation • CD7

CD7-Targeted CAR-T Cell Therapy Shows Promising Efficacy and Safety in Treating Refractory/Relapsed Peripheral T-Cell Lymphoma: Phase I Clinical Trial (ASH 2024) - P=N/A | "We have previously demonstrated that "naturally selected" CD7 CAR-T (NS7CAR-T) therapy shows significant efficacy with a favorable safety profile in 60 patients with T-ALL and T-cell lymphoblastic lymphoma (T-LBL)...All patients received intravenous fludarabine (30mg/m2/d) and cyclophosphamide (300mg/m2/d) lymphodepletion chemotherapy for three consecutive days (day -5 to day -3)...Conclusions Our study highlights that CD7-positive heavy pre-treated R/R PTCL patients could achieve a promising CR and safety profile after CD7-targeted CAR-T therapy, who otherwise have very limited therapy options. More data on additional patients and longer observation times are needed to further evaluate the efficacy and safety of CD7 CAR-T products in treating PTCL."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Hepatosplenic T-cell Lymphoma • Immunology • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • T-cell Acute Lymphoblastic Lymphoma • CD7

Immune reconstitution after CD7 CAR-T cell therapy for refractory/relapsed acute T-lymphoblastic leukaemia/lymphoblastic lymphoma (R/R T-ALL/LBL). (PubMed, Br J Haematol) - "We compared infection rates and immune cell subsets in 60 R/R T-ALL/LBL patients receiving naturally selected CD7 CAR-T (NS7CAR-T) with 60 R/R B-ALL patients undergoing CD19 CAR-T...This study indicates that while CD7 CAR-T therapy significantly reduces CD7(+) T cells, it does not lead to increased short-term infection rates. The notable expansion of non-CAR-T-derived CD7(-) T and NK cells helps preserve immune function, highlighting distinct therapeutic mechanisms between CD7 CAR-T and CD19 CAR-T due to their different lineage restrictions."

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • CD7

New Concepts and Future Perspectives of CD7 CAR T-cell Therapy for Hematologic Malignancy (ICBMT 2025) - "In this presentation, will focus on a Universal (U) CD7 CAR-T (CTD402) for treating refractory and relapsed (R/R) T-ALL/LBL (multi-center IIT clinical trials) and autologous CD7CAR-T for R-TALL/LBL (phase I/II clinical trial) followed by allo-HSCT...Our previous studies have demonstrated that NS7CAR-T therapy is effective in treating R/R T-ALL/LBL patients with promising long-term outcomes while maintaining a manageable safety profile...Patients aged ~14 in the CD7 CAR-T group achieved high 2-year OS and LFS rates of 87.5%. Our study indicates that CD7 CAR-T therapy followed by allo-HSCT is not only effective and safe for r/r T-ALL/LBL patients but also on par with the outcomes of those achieving CR through chemotherapy, without increasing NRM."

CAR T-Cell Therapy • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD7

CD7 CAR-T Therapy for Treating CD7-Positive Hematological Malignancies (SOHO 2024) - P=N/A, P1 | "Our study highlights the NS7CAR-T therapy as a promising approach for achieving a favorable initial CR in CD7-positive AML patients, even in those who have undergone extensive prior treatments and experienced relapse post-transplant. The safety profile of NS7CAR-T therapy was manageable."

Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CD7

IMMUNE RECONSTITUTION AFTER CD7 CAR-T CELL THERAPY FOR REFRACTORY /RELAPSED ACUTE T-LYMPHOBLASTIC LEUKEMIA/LYMPHOBLASTIC LYMPHOMA(R/R T-ALL/LBL) (EHA 2024) - P=N/A, P1 | " Between December 2020, and July 2022, 60 patients with R/R T-ALL/LBL received naturally selected CD7 CAR-T(NS7CAR-T) therapy (NCT04572308, NCT04916860)... Our study demonstrated that post-CD7CAR-T therapy, T-ALL/LBL patients did not experience serious sideeffects, and no significant increase in overall infection rates occurred yet with a higher incidence of fungalinfections compared to CD19 CAR-T group. We found despite a significant reduction in CD7+ T cells, non-CAR-T CD7 (-) T cells showed an evident increase, which may be responsible for maintaining immune function. Given this, the CD7 CAR-T did not exert a substantial impact on immune function."

CAR T-Cell Therapy • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • CD7

Cell Therapy for CD7 Positive Acute Myeloid Leukemia or Mixed Lineage Leukemia (clinicaltrials.gov) - P=N/A | N=50 | Completed | Sponsor: Hebei Senlang Biotechnology Inc., Ltd. | Recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Oct 2023

CAR T-Cell Therapy • Trial completion • Trial completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD7

CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Orphan Designation: Treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma (FDA) - Date Designated: 08/31/2023

Orphan drug • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma (clinicaltrials.gov) - P=N/A | N=100 | Active, not recruiting | Sponsor: Hebei Senlang Biotechnology Inc., Ltd. | Recruiting ➔ Active, not recruiting

CAR T-Cell Therapy • Enrollment closed • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CD7 • IL10 • IL6