^
    5ms
    Cell Therapy for CD7 Positive Acute Myeloid Leukemia or Mixed Lineage Leukemia (clinicaltrials.gov)
    P=N/A, N=50, Completed, Hebei Senlang Biotechnology Inc., Ltd. | Recruiting --> Completed | Trial completion date: Jun 2023 --> Oct 2023
    Trial completion • Trial completion date • CAR T-Cell Therapy
    |
    CD7 (CD7 Molecule)
    |
    cyclophosphamide • SENL101
    12ms
    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
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    CD8 positive
    |
    SENL101
    12ms
    CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study (clinicaltrials.gov)
    P1, N=9, Recruiting, Hebei Senlang Biotechnology Inc., Ltd.
    New P1 trial
    |
    SENL101
    over1year
    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, Hebei Senlang Biotechnology Inc., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • CAR T-Cell Therapy
    |
    IL6 (Interleukin 6) • IL10 (Interleukin 10) • CD7 (CD7 Molecule)
    |
    CD7 expression
    |
    SENL101
    almost2years
    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, Hebei Senlang Biotechnology Inc., Ltd.
    New trial • CAR T-Cell Therapy
    |
    CD7 (CD7 Molecule)
    |
    CD7 expression
    |
    SENL101
    over2years
    SENL101 Autologous T Cell Injection in Adults With Relapsed or Refractory CD7+ Hematolymphoid Malignancies (clinicaltrials.gov)
    P1, N=18, Recruiting, Hebei Senlang Biotechnology Inc., Ltd.
    New P1 trial
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CD7 (CD7 Molecule)
    |
    SENL101
    over2years
    Naturally Selected CD7 CAR-T Therapy without Genetic Manipulations for T-ALL/LBL: First-in-human Phase I Clinical Trial. (PubMed, Blood)
    More patients and longer follow-up are needed for validation. Clinical Trial can be found at NCT04572308, https://clinicaltrials.gov/.
    P1 data • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD7 (CD7 Molecule)
    |
    SENL101
    almost3years
    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)
    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 • P1 data • IO biomarker
    |
    FLT3 (Fms-related tyrosine kinase 3) • CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CD7 (CD7 Molecule)
    |
    FLT3 mutation
    |
    cyclophosphamide • fludarabine IV • SENL101
    3years
    Naturally Selected Anti-CD7 CAR-T Cells without Additional Genetic Manipulations As a Potentially Superior Therapy for T-Cell Malignancies (ASH 2021)
    Importantly, our data indicate that autologous PBMCs from patients were superior to PBMCs of healthy donors in yielding sufficient NS7CAR T cells for therapeutic needs. An investigator-initiated trial is currently ongoing to test the feasibility, efficacy, and safety of NS7CAR T cells for treating T-cell acute lymphoblastic leukemia.
    CAR T-Cell Therapy • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    CD7 expression
    |
    SENL101
    3years
    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)
    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 • P1 data • IO biomarker
    |
    FLT3 (Fms-related tyrosine kinase 3) • CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CD7 (CD7 Molecule)
    |
    FLT3 mutation
    |
    cyclophosphamide • fludarabine IV • SENL101
    3years
    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)
    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.
    Clinical • CAR T-Cell Therapy
    |
    TP53 (Tumor protein P53) • EZH2 (Enhancer of zeste 2 polycomb repressive complex 2 subunit) • RUNX1 (RUNX Family Transcription Factor 1) • CD7 (CD7 Molecule)
    |
    TP53 expression
    |
    cyclophosphamide • fludarabine IV • SENL101
    3years
    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)
    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.
    Clinical • CAR T-Cell Therapy
    |
    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53) • RUNX1 (RUNX Family Transcription Factor 1) • JAK1 (Janus Kinase 1) • JAK3 (Janus Kinase 3)
    |
    cyclophosphamide • fludarabine IV • SENL101
    over3years
    Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T Cells (clinicaltrials.gov)
    P1, N=20, Completed, Hebei Senlang Biotechnology Inc., Ltd. | Recruiting --> Completed | Phase classification: PN/A --> P1 | N=100 --> 20 | Trial completion date: Dec 2022 --> May 2021 | Trial primary completion date: Oct 2022 --> May 2021
    Trial completion • Phase classification • Enrollment change • Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • CD7 (CD7 Molecule)
    |
    SENL101
    over3years
    Cell Therapy for CD7 Positive Acute Leukemia or Mixed Lineage Leukemia Except Those Who Are Diagnosed With T-ALL/T-LBL Using CD7-Specific CAR-T Cells (clinicaltrials.gov)
    P=N/A, N=50, Recruiting, Hebei Senlang Biotechnology Inc., Ltd.
    New trial • CAR T-Cell Therapy
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • CD7 (CD7 Molecule)
    |
    SENL101
    over3years
    Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T Cells (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, Hebei Senlang Biotechnology Inc., Ltd. | N=20 --> 100
    Enrollment change • CAR T-Cell Therapy
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • CD7 (CD7 Molecule)
    |
    SENL101
    4years
    Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T Cells (clinicaltrials.gov)
    P=N/A, N=20, Recruiting, Hebei Senlang Biotechnology Inc., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • CD7 (CD7 Molecule)
    |
    SENL101
    4years
    Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T Cells (clinicaltrials.gov)
    P=N/A, N=20, Not yet recruiting, Hebei Senlang Biotechnology Inc., Ltd.
    New trial • CAR T-Cell Therapy
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • CD7 (CD7 Molecule)
    |
    SENL101