CD19 CAR T cells / City of Hope, National Cancer Institute - LARVOL DELTA

Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=71 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Sep 2025 ➔ Jul 2026 | Trial primary completion date: Sep 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • High-grade B-cell lymphoma • Hodgkin Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma • Transplantation • Waldenstrom Macroglobulinemia

Memory Enriched T Cells Following Stem Cell Transplant in Treating Patients With Recurrent B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • B Cell Lymphoma • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • High-grade B-cell lymphoma • Hodgkin Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma • Transplantation • Waldenstrom Macroglobulinemia

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

CAR T-Cell Therapy • Immune cell • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=71 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Sep 2024 ➔ Sep 2025 | Trial primary completion date: Sep 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Sep 2024 ➔ Dec 2024

CAR T-Cell Therapy • Immune cell • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Humanized CD19-Specific CAR T Cells for the Treatment of Patients With Positive Relapsed or Refractory CD19 Positive B-Cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Aug 2025 ➔ Dec 2026 | Trial primary completion date: Aug 2025 ➔ Dec 2026

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

Humanized CD19-Specific CAR T Cells for the Treatment of Patients With Positive Relapsed or Refractory CD19 Positive B-Cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: City of Hope Medical Center

CAR T-Cell Therapy • New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma • Transplantation • Waldenstrom Macroglobulinemia

Memory Enriched T Cells Following Stem Cell Transplant in Treating Patients With Recurrent B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD28

CD19 CAR T Cells Plus Acalabrutinib Shows Early Activity in Relapsed/Refractory MCL (OncLive) - P2 | N=36 | NCT04484012 | "CD19 CAR T cells paired with acalabrutinib (Calquence) was found to be well tolerated and to elicit responses in patients with relapsed/refractory mantle cell lymphoma...In evaluable patients (n = 8), the overall response rate (ORR) was 88%, with a complete response rate (CR) of 75%; 50% of patients achieved a CR with minimal residual disease (MRD) negativity (< 10-4), and 25% had a CR with MRD positivity...the partial response (PR) rate was 12.5% and 12.5% of patients had stable disease...In those who received the CD19 product at 200 x 106 CAR-positive cells, which was dose level 1, the ORR achieved with the combination was 75%...The median follow-up following CAR T infusion was 20.3 months (range, 12.0-32.2). The median progression-free survival (PFS) was 14.7 months (95% CI, 9-not estimable [NE]) and the median overall survival (OS) was not reached....At dose level 2, accrual of patients is ongoing."

Enrollment status • P2 data • Mantle Cell Lymphoma

Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=71 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Sep 2023 ➔ Sep 2024 | Trial primary completion date: Sep 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial primary completion date • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Immune Modulation • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma • Transplantation • Waldenstrom Macroglobulinemia

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2023 ➔ Sep 2024 | Trial primary completion date: Dec 2023 ➔ Sep 2024

CAR T-Cell Therapy • Immune cell • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Memory Enriched T Cells Following Stem Cell Transplant in Treating Patients With Recurrent B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immune Modulation • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD19 • CD28

Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=71 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2022 ➔ Sep 2023 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Immune Modulation • Inflammation • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD19

Results from a Phase 1 Study to Evaluate a Memory-Enriched CD19-Specific CAR T Cell Platform in Adult Patients with CD19+ B-Cell Non-Hodgkin Lymphoma (B-NHL) (ASH 2021) - P1 | "All but 1 patient received a fludarabine/cyclophosphamide (Flu/Cy)-based lymphodepletion regimen prior to receiving CD19CART at 1 of 2 dose levels (DL): DL1=200 million (M) and DL2=600M CAR+ T cells... This clinical study provides evidence for the safety, feasibility and efficacy of Tn/mem-derived CD19CART preceded by Flu/Cy lymphodepletion for the treatment of r/r B-NHL. We plan to pursue this CAR T cell platform in future B-NHL studies, particularly for CNS lymphoma given the encouraging safety and efficacy of CD19CART in the 5 PCNSL patients."

CAR T-Cell Therapy • Clinical • P1 data • CNS Disorders • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Inflammation • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pain • Richter's Syndrome • Transplantation • Waldenstrom Macroglobulinemia • CD19

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Jun 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Immune Modulation • Inflammation • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma • Transplantation • Waldenstrom Macroglobulinemia • CD19

Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=71 | Active, not recruiting | Sponsor: City of Hope Medical Center | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2022 ➔ Sep 2022

Enrollment closed • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Immune Modulation • Inflammation • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD19

Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: City of Hope Medical Center | N=54 ➔ 37 | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Jun 2022

Enrollment change • Trial completion date • Trial primary completion date • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Immune Modulation • Inflammation • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prolymphocytic Leukemia • Small Lymphocytic Lymphoma • Transplantation • Waldenstrom Macroglobulinemia • CD19

Memory Enriched T Cells Following Stem Cell Transplant in Treating Patients With Recurrent B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD19 • CD28

Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Immune Modulation • Inflammation • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD19

Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov) - P2; N=36; Recruiting; Sponsor: City of Hope Medical Center; Trial completion date: Sep 2023 ➔ Dec 2023; Trial primary completion date: Sep 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CD19