MB-CART20.1 / Miltenyi Biotec - LARVOL DELTA

MB-CART20.1 Lymphoma (clinicaltrials.gov) - P1/2 | N=10 | Completed | Sponsor: Miltenyi Biomedicine GmbH | Active, not recruiting ➔ Completed | N=19 ➔ 10

Enrollment change • Trial completion • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Automated manufacturing and characterization of clinical grade autologous CD20 CAR T cells for the treatment of patients with stage III/IV melanoma. (PubMed, Front Immunol) - P1 | "In conclusion, the CliniMACS Prodigy® platform is well suited for decentralized POC manufacturing of anti-CD20 CAR T cells and may be likewise applicable for the rapid and automated manufacturing of CAR T cells directed against other targets. https://clinicaltrials.gov/study/NCT03893019?cond=Melanoma&term=NCT03893019&rank=1, identifier NCT03893019."

CAR T-Cell Therapy • Journal • Hematological Disorders • Melanoma • Oncology • Solid Tumor • CD20 • CD4 • CD8

LONGSAFE: Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies (clinicaltrials.gov) - P=N/A | N=40 | Recruiting | Sponsor: Miltenyi Biomedicine GmbH

Gene therapy • New trial • Chronic Lymphocytic Leukemia • Gene Therapies • Hematological Malignancies • Leukemia • Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • Solid Tumor

MB-CART20.1 Melanoma (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Miltenyi Biomedicine GmbH | N=15 ➔ 9 | Recruiting ➔ Terminated; The risk-benefit assessment was not as expected.

Enrollment change • Metastases • Trial termination • Melanoma • Oncology • Solid Tumor

MB-CART20.1 Lymphoma (clinicaltrials.gov) - P1/2 | N=19 | Active, not recruiting | Sponsor: Miltenyi Biomedicine GmbH | Trial completion date: Nov 2022 ➔ Sep 2024 | Trial primary completion date: Feb 2022 ➔ Sep 2024

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

A Phase I Dose Finding Trial of MB-CART20.1 in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (ASH 2022) - "Patients underwent lymphodepletion with fludarabine (30 mg/m2) and cyclophosphamide (300 mg/m2), each from day -5 to day -3...One CRS case was managed with tocilizumab...In total 3 patients achieved a CR and remained in remission for at least one year. The two patients treated at the higher DL, achieved a CR indicating a dose-response correlation."

Clinical • P1 data • Aplastic Anemia • CNS Disorders • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Septic Shock • CD19 • CD4 • CD8

MB-CART20.1 Melanoma (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: Miltenyi Biomedicine GmbH; Trial completion date: Jul 2021 ➔ Jul 2022; Trial primary completion date: Jul 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • CD20

MB-CART20.1 Lymphoma (clinicaltrials.gov) - P1/2; N=19; Active, not recruiting; Sponsor: Miltenyi Biomedicine GmbH; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

[VIRTUAL] Extending CAR T cell therapy applications via drug inducible control of transgene expression (ITOC-I 2020) - "Background Adoptive transfer of chimeric antigen receptor (CAR)-modified T cells has emerged as a promising treatment modality for a broad range of cancers highlighted by the approval of Kymriah™ and Yescarta™ for the treatment of B cell malignancies...Conclusions The zinc-finger-based transcriptional control system investigated in this study provides small molecule-inducible control over a therapeutically relevant anti-CD20 CAR in primary T cells in a timeand dose-dependent manner. The tight regulation of CAR expression will pave the way for safer cellular therapies."

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

MB-CART20.1 Melanoma (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: Miltenyi Biotec GmbH

Clinical • New P1 trial