S101 / SenlangBio - LARVOL DELTA

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-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

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

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

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

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

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

First-in-Human Clinical Study of a Novel CD7-Targeted Chimeric Antigen Receptor (CAR)-T Cell Therapy for Refractory/Relapsed Mixed Phenotype Acute Leukemia (MPAL) (ASH 2021) - P=N/A | "Prior to the CAR-T cells infusion, patients received systemic bridging chemotherapy due to rapid disease progression and then all patients received intravenous fludarabine (30mg/m 2 /d) and cyclophosphamide (300mg/m 2 /d) (FC) lymphodepleting chemotherapy for 3 consecutive days (Day -5 to Day -3)...Conclusion This study demonstrated that CD7-targeted CAR-T therapy offers an opportunity to achieve CR for CD7-positive MPAL patients even for those who relapsed post-transplant. Safety was manageable, however, more data on additional patients and longer observation times are needed to further evaluate the efficacy of CD7 CAR-T products."

Clinical • IO biomarker • P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Leukemia • Oncology • Transplantation • CD19 • CD4 • CD7 • CD8 • FLT3

Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

CAR T-Cell Therapy • New trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CD7

First-in-Human Clinical Study of a Novel CD7-Targeted Chimeric Antigen Receptor (CAR)-T Cell Therapy for Refractory/Relapsed Mixed Phenotype Acute Leukemia (MPAL) (ASH 2021) - P=N/A | "Prior to the CAR-T cells infusion, patients received systemic bridging chemotherapy due to rapid disease progression and then all patients received intravenous fludarabine (30mg/m 2 /d) and cyclophosphamide (300mg/m 2 /d) (FC) lymphodepleting chemotherapy for 3 consecutive days (Day -5 to Day -3)...Conclusion This study demonstrated that CD7-targeted CAR-T therapy offers an opportunity to achieve CR for CD7-positive MPAL patients even for those who relapsed post-transplant. Safety was manageable, however, more data on additional patients and longer observation times are needed to further evaluate the efficacy of CD7 CAR-T products."

Clinical • IO biomarker • P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Leukemia • Oncology • Transplantation • CD19 • CD4 • CD7 • CD8 • FLT3

A Novel and Successful Patient or Donor-Derived CD7-Targeted CAR T-Cell Therapy for Relapsed or Refractory T-Cell Lymphoblastic Lymphoma (R/R T-LBL) (ASH 2021) - P=N/A | "Intravenous fludarabine (30 mg/m 2 /d) and cyclophosphamide (300 mg/m 2 /d) were given to all patients on Day -5 to Day -3 prior to CD7CAR infusion...However, patients with bulky mediastinal masses may require more than one-month time to achieve remission. Long-term observation and more patients are needed to further evaluate the safety and efficacy of CD7CAR."

CAR T-Cell Therapy • Clinical • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Inflammation • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • CD7 • EZH2 • RUNX1 • TP53

High Effectiveness and Safety of Anti-CD7 CAR T-Cell Therapy in Treating Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL) (ASH 2021) - P1 | "All patients received intravenous fludarabine (30 mg/m 2 /d) and cyclophosphamide (300 mg/m 2 /d) for 3 days prior to CD7CAR infusion...Conclusions Our results demonstrate that CD7CAR therapy is safe and highly effective in treating patients with heavily pretreated R/R T-ALL, including those with extramedullary involvements, a history of prior allo-HSCT or with high-risk subtypes. More patients and a longer observation time are needed to further evaluate the potential beneficial advantages and side effects of CD7CAR therapy for T-ALL patients."

CAR T-Cell Therapy • Clinical • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • Transplantation • EGFR • JAK1 • JAK3 • RUNX1 • TP53