C-CAR011 / Chinese PLA General Hospital, AbelZeta Pharma - LARVOL DELTA

2022 Chinese expert consensus and guidelines on clinical management of toxicity in anti-CD19 chimeric antigen receptor T-cell therapy for B-cell non-Hodgkin lymphoma. (PubMed, Cancer Biol Med) - "Consequently, we developed this consensus for the prevention, recognition, and management of these toxicities, on the basis of published literature regarding the management of anti-CD19 CAR T-cell-associated toxicities and the clinical experience of multiple Chinese institutions. This consensus refines a grading system and classification of CRS in B-NHL and corresponding measures for CRS management, and delineates comprehensive principles and exploratory recommendations for managing anti-CD19 CAR T-cell-associated toxicities in addition to CRS."

CAR T-Cell Therapy • Clinical guideline • Journal • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Anti-PD-1 antibodies as a salvage therapy for patients with diffuse large B cell lymphoma who progressed/relapsed after CART19/20 therapy. (PubMed, J Hematol Oncol) - "After anti-PD-1 treatment, circulating T cells were activated in responders, and no significant expansion of CART19/20 cells was detected. Our data suggest that PD-1 blockade therapy can be active in patients with relapsed/refractory DLBCL after failure of CAR T cell therapy who had PD-L1 expression in tumor cells and high PD-1 level in tumor-infiltrated T cells."

Clinical • IO biomarker • Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

[VIRTUAL] CAR T cells undergoing epigenetic reprogramming by low-dose decitabine enhances persistent anti-tumor efficacy in vivo. (SITC 2020) - "Methods We treated CAR (CAR-CD19-expressing) T cells with low-dose DAC (dCAR T cells), to determine its effects on antitumor activities, exhaustion- and memory-associate cell phenotype change, cell cytokine production, and cell proliferation. dCAR T cells avoided the exhaustion programme induced during tumour cell stimulation; they did not upregulate the expression of genes encoding inhibitory receptors and retained relatively high expression of memory related transcription factors and genes. Conclusions CAR T cells underwent DNA reprogramming after DAC treatment, which induced significant sustained cell expansion, cytotoxicity, and cytokine production and reduced exhaustion after antigen exposure."

CAR T-Cell Therapy • Late-breaking abstract • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD8 • DNMT3A

[VIRTUAL] CAR T cells undergoing epigenetic reprogramming by low-dose decitabine enhances persistent anti-tumor efficacy in vivo. (SITC 2020) - "Methods We treated CAR (CAR-CD19-expressing) T cells with low-dose DAC (dCAR T cells), to determine its effects on antitumor activities, exhaustion- and memory-associate cell phenotype change, cell cytokine production, and cell proliferation. dCAR T cells avoided the exhaustion programme induced during tumour cell stimulation; they did not upregulate the expression of genes encoding inhibitory receptors and retained relatively high expression of memory related transcription factors and genes. Conclusions CAR T cells underwent DNA reprogramming after DAC treatment, which induced significant sustained cell expansion, cytotoxicity, and cytokine production and reduced exhaustion after antigen exposure."

CAR T-Cell Therapy • Late-breaking abstract • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD8 • DNMT3A

C-CAR011 Treatment in Subjects With ALL After HSCT (clinicaltrials.gov) - P=N/A; N=40; Active, not recruiting; Sponsor: Peking University People's Hospital; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD19

Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

New P1 trial • Acute Lymphocytic Leukemia • Biosimilar • Graft versus Host Disease • Hematological Malignancies • Leukemia • Oncology

Cellular Biomedicine: Biotech Showcase 2016 (Cellular Biomedicine Group) - Anticipated initiation of P1/2b trials in multiple indications in China in H1 2016; Anticipated initiation of multicenter trial in adult B-ALL in 2016

Anticipated new P1/2 trial • Anticipated new trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Oncology

A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL Subjects (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Peking Union Medical College Hospital; Not yet recruiting ➔ Completed; N=10 ➔ 6

Clinical • Enrollment change • Trial completion

Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences; Trial completion date: May 2018 ➔ May 2020; Trial primary completion date: May 2017 ➔ May 2019

Clinical • Trial completion date • Trial primary completion date

A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 Treatment in DLBCL Subjects (clinicaltrials.gov) - P1; N=15; Completed; Sponsor: Cellular Biomedicine Group Ltd.; Recruiting ➔ Completed; Trial completion date: Jan 2018 ➔ Jan 2019; Trial primary completion date: Nov 2017 ➔ Sep 2018

Clinical • Trial completion • Trial completion date • Trial primary completion date