human anti CD19 CAR-T cells / Case Comprehensive Cancer Center - LARVOL DELTA

Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Benjamin Tomlinson | Suspended ➔ Active, not recruiting | N=36 ➔ 18

Enrollment change • Enrollment closed • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=36 | Suspended | Sponsor: Benjamin Tomlinson | Trial primary completion date: Mar 2025 ➔ Sep 2025

Trial primary completion date • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Treatment of non-Hodgkin lymphoma with point-of-care manufactured CAR T cells: a dual institution, phase 1 trial. (PubMed, EClinicalMedicine) - "MB-CART-19 is an anti-CD19 CAR T-cell product manufactured using the CliniMACS Prodigy device with 4-1BB and CD3ζ costimulatory domains. Lymphodepletion included fludarabine 25 mg/m2 for 3 days and cyclophosphamide 60 mg/kg for 1 day. Prophylactic tocilizumab was allowed...This clinical trial was funded through University Hospitals Seidman Cancer Center and Washington University School of Medicine Institutional Funds. Correlative analyses were funded in part by the European Union-Next Generation EU-NRRP M6C2-Investment 2.1 Enhancement and strengthening of biomedical research in the NHS (project #PNRR-MAD-2022-12376059), and the Italian Ministry of Health Ricerca Finalizzata 2019 (project #RF-2019-12370243)."

Journal • P1 data • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia

Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=36 | Suspended | Sponsor: Benjamin Tomlinson | Recruiting ➔ Suspended

Trial suspension • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Benjamin Tomlinson | Trial completion date: Dec 2024 ➔ Dec 2039 | Trial primary completion date: Jun 2024 ➔ Mar 2025

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Non Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Benjamin Tomlinson

CAR T-Cell Therapy • Trial completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Non Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Benjamin Tomlinson | Trial primary completion date: Oct 2023 ➔ Mar 2023

Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

NCCN Guidelines® Insights: B-Cell Lymphomas, Version 6.2023. (PubMed, J Natl Compr Canc Netw) - "Anti-CD19 CAR T-cell therapies are now effective and approved treatment options for relapsed/refractory follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and MCL. Bispecific T-cell engagers represent a novel immunotherapeutic approach for relapsed FL and DLBCL after multiple lines of therapies, including prior CAR T-cell therapy. These NCCN Guideline Insights highlight the significant updates to the NCCN Guidelines for B-Cell Lymphomas for the treatment of FL, DLBCL, and MCL."

Journal • NCCN guideline • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Non Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Benjamin Tomlinson | Trial completion date: Jul 2023 ➔ Dec 2023 | Trial primary completion date: Apr 2023 ➔ Oct 2023

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Benjamin Tomlinson | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Non Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Benjamin Tomlinson | Trial completion date: Jul 2022 ➔ Jul 2023 | Trial primary completion date: Jul 2022 ➔ Apr 2023

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Final Results of a Phase 1 Study of AntiCD19 CAR-T Cells with TNFRSF19 Transmembrane Domain (ASH 2021) - "Lymphodepletion included cyclophosphamide (60mg/kg x 1) and fludarabine (25mg/m2/d x 3)...Treatment for CRS / ICANS included tocilizumab (n = 12), siltuximab (n = 4), anakinra (n = 3) and corticosteroids (n = 10)... Second generation antiCD19 CAR-T cells with TNFRS19 transmembrane domain have potent clinical activity. On-site manufacture was successful in all pts. This strategy, in combination with fresh product infusion, can make CAR-T cell therapy rapidly available for pts with high-risk r/r B cell lymphoma."

CAR T-Cell Therapy • Clinical • P1 data • Fatigue • Hematological Disorders • Hematological Malignancies • Inflammation • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CCL19 • CD8 • TNFRSF9

AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Non Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Benjamin Tomlinson | Trial completion date: Oct 2021 ➔ Jul 2022 | Trial primary completion date: Oct 2021 ➔ Jul 2022

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

The AntiCD19 Antibody Drug Immunoconjugate Loncastuximab Achieves Responses in DLBCL Relapsing After AntiCD19 CAR-T Cell Therapy. (PubMed, Clin Lymphoma Myeloma Leuk) - "Loncastuximab can achieve responses in patients progressing after CAR-T cells. Sequencing CD19-targeting therapies is possible in cases without CD19 loss."

CAR T-Cell Therapy • Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Benjamin Tomlinson; Not yet recruiting ➔ Recruiting; Initiation date: Sep 2021 ➔ Apr 2021

Clinical • Enrollment open • Trial initiation date • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Non Hodgkin Lymphoma (clinicaltrials.gov) - P1; N=31; Active, not recruiting; Sponsor: Benjamin Tomlinson; Recruiting ➔ Active, not recruiting; N=18 ➔ 31; Trial completion date: Jul 2021 ➔ Oct 2021; Trial primary completion date: Apr 2021 ➔ Oct 2021

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Paolo Caimi, MD; Initiation date: Feb 2021 ➔ Sep 2021

Clinical • Trial initiation date • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Paolo Caimi, MD

Clinical • New P1 trial • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology