JNJ-9530 / AbelZeta Pharma, J&J - LARVOL DELTA

A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL) (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: May 2027 ➔ May 2039

Trial completion date • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

C-CAR066, a novel fully human anti-CD20 CAR-T therapy for relapsed or refractory large B-cell lymphoma after failure of anti-CD19 CAR-T therapy: A phase I clinical study. (PubMed, Am J Hematol) - P1 | "C-CAR066 demonstrated a manageable safety profile and promising efficacy in patients in whom prior anti-CD19 CAR-T therapies had failed, providing a promising treatment option for those patients. This trial was registered with ClinicalTrials.gov, NCT04316624 and NCT04036019."

Journal • P1 data • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL) (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=92 ➔ 20

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

TWO-YEAR FOLLOW-UP RESULTS OF C-CAR066, A NOVEL ANTI-CD20 CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY IN RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA PATIENTS AFTER FAILURE OF CD19 CAR-T THERAPY (EHA 2024) - "0×106 CAR- T cells/kg experienced a grade 4 CRS and recovered after receivingglucocorticoid and tocilizumab. C-CAR066 demonstrated a manageable safety profile and a deep and durable response in pts with r/r LBCLwho had failed from a prior CD19 CAR-T therapy."

CAR T-Cell Therapy • Clinical • Anemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Thrombocytopenia • CD22 • CD79B

Two-Year Follow-up Results of C-CAR066, a Novel Anti-CD20 Chimeric Antigen Receptor Cell Therapy (CAR-T) in Relapsed or Refractory (r/r) Large B-Cell Lymphoma (LBCL) Patients after Failure of CD19 CAR-T Therapy (ASH 2023) - "This pt recovered after receiving corticosteroids and tocilizumab. Longer term follow-up demonstrated that C-CAR066 can produce a deep and durable response with a favorable safety profile in pts with r/r LBCL who failed prior CD19 CAR-T therapy."

Clinical • Anemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • CD22 • CD79B

AbelZeta Announces Amendment to Worldwide Collaboration and License Agreement with Janssen to Include China (PRNewswire) - "AbelZeta Pharma, Inc...today announced an amendment of its worldwide collaboration and license agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company. Under the amended agreement, Janssen will have the option to obtain exclusive commercialization rights in China for CD20-directed chimeric antigen receptor T (CAR-T) C-CAR039 and C-CAR066, which are being studied for the treatment of Non-Hodgkin Lymphoma (NHL)....Under the terms of the agreement, Janssen will pay AbelZeta Pharma an option exercise fee, and AbelZeta Pharma is eligible to receive commercialization and sales milestones."

Licensing / partnership • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AbelZeta Presents Data from Two Clinical Studies Relating to its Immuno-Oncology Drug Development at the 65th ASH Annual Meeting (PRNewswire) - N=14 | "Key Results of C-CAR066: Between October 16, 2019, and August 17, 2021, a total of 14 patients received C-CAR066 at doses of 2.0x106 CAR-T cells/kg and 3.0x106 CAR-T cells/kg...12/14 patients (85.7%) experienced CRS, all were grade 1/2, except for 1 patient who experienced a grade 4 CRS. No patients experienced ICANS. Grade 3 or higher cytopenia not resolved by Day 30 following C-CAR066 infusion occurred in 28.6% patients and included neutropenia (21.4%), thrombocytopenia (14.3%), and anemia (14.3%). At cutoff date, 8 patients experienced infections, only 2 were grade 3....ORR was 92.9%, with 57.1% CR."

Clinical data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AbelZeta Announces Two Abstracts Accepted for Presentation at the 65th ASH Annual Meeting (PRNewswire) - "AbelZeta Pharma, Inc...announced today that two abstracts relating to its immuno-oncology drug development have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition to be held in San Diego, California, and online from December 9 to 12, 2023."

Clinical data • P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL) (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting | Phase classification: P1b ➔ P1 | N=52 ➔ 92 | Trial completion date: Nov 2026 ➔ May 2027 | Trial primary completion date: May 2026 ➔ Apr 2027

CAR T-Cell Therapy • Enrollment change • Enrollment open • Phase classification • Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL) (clinicaltrials.gov) - P1b | N=52 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P1 ➔ P1b | Trial completion date: May 2026 ➔ Nov 2026

Phase classification • Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine | Unknown status ➔ Completed

Trial completion • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Institute of Hematology & Blood Diseases Hospital | Unknown status ➔ Completed | N=10 ➔ 7 | Trial completion date: Dec 2021 ➔ Feb 2023 | Trial primary completion date: Aug 2021 ➔ Feb 2023

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

C-CAR066 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL) (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC | N=15 ➔ 52 | Trial completion date: Oct 2025 ➔ May 2026 | Initiation date: Jul 2023 ➔ Oct 2023 | Trial primary completion date: Jul 2025 ➔ May 2026

CAR T-Cell Therapy • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

CAR-T: Janssen agrees with Cellular Biomedicine Group [Google translation] - "Janssen to pay $245 million upfront as part of an agreement with biotech Cellular Biomedicine Group (CBMG) to develop autologous CAR T-cell therapies targeting CD20 for the treatment of B-cell malignancies, the two announced. society. The agreement covers C-CAR066 and the bi-specific drug C-CAR039, which also targets CD19...Under the agreed terms, CBMG will grant Janssen a global license to develop and commercialize the CAR-T assets, with the exception of Greater China, where the companies will negotiate an option for Janssen to commercialize the products. In addition to the upfront payment, CBMG is entitled to additional future milestones and royalties on worldwide sales excluding Greater China."

Licensing / partnership • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Cellular Biomedicine Group Announces Exclusive Collaboration and License Agreement with Janssen to Develop and Commercialize anti CD19 & CD20 Bi-Specific and anti CD20 CAR-Ts for Non-Hodgkin Lymphoma (PRNewswire) - "Cellular Biomedicine Group Inc...announced that the Company has entered into a global collaboration and license agreement with Janssen Biotech, Inc. (Janssen) for C-CAR039, an anti-CD19 & CD20 bi-specific chimeric antigen receptor T-cell (CAR-T) therapy, and C-CAR066, an anti-CD20 CAR-T, which have been studied for the treatment of Non-Hodgkin Lymphoma (NHL)....Under the terms of the agreement, Janssen will receive an exclusive license to develop and commercialize C-CAR039 and C-CAR066 in geographic territories outside of China, and the parties will negotiate an option for Janssen to develop the China territory subject to certain deadlines before the Company files the Biologics License Application (BLA) application in China. CBMG will transfer IND and studies for C-CAR039 (NCT05421663) and C-CAR066 (NCT05784441) to Janssen and will supply the initial clinical trial materials comprised of viral vector and plasmid, as well as assist Janssen on the technology transfer. "

Licensing / partnership • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

C-CAR066 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL) (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Cellular Biomedicine Group, Inc.

CAR T-Cell Therapy • New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

[VIRTUAL] Early Clinical Results of a Novel Anti-CD20 Chimeric Antigen Receptor (CAR)-T Cell Therapy for B-Cell NHL Patients Who Are Relapsed/Resistant Following CD19 CAR-T Therapy (ASH 2020) - P1 | "Preclinical studies suggest that C-CAR066 has superior anti-tumor activity compared to CAR-Ts derived from scFVs of Leu16, Rituximab, and Obinutuzumab, NCT04036019 is a single arm, single-center, non-randomized phase I clinical trial conducted at Shanghai Tongji Hospital to evaluate the safety and efficacy of C-CAR066 in subjects with r/r B cell lymphoma who were previously treated with anti-CD19 CAR-T therapy...C-CAR066 is administered to patients as a single intravenous dose after a standard 3-day cyclophosphamide/fludarabine conditioning regimen... C-CAR066 has a favorable safety profile and shows promising early efficacy in patients with r/r NHL following CD19 CAR-T therapy. It confirms that C-CAR066 has a different mechanism of action compared to anti-CD-19 CAR-T therapy. These data provide strong scientific rationale to the strategy of targeting both CD20 and CD19 tumor antigens and to ask whether this leads to superior clinical benefit to targeting either..."

Clinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

[VIRTUAL] Safety and efficacy of a novel anti-CD20 chimeric antigen receptor (CAR)-T cell therapy in relapsed/refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL) patients after failing CD19 CAR-T therapy. (ASCO 2021) - P1 | "Preclinical studies suggest that C-CAR066 has superior anti-tumor activity compared to CAR-Ts derived from scFVs of Leu16, Rituximab and Obinutuzumab and anti-CD19 BBZ CAR with FMC63...A 3-day cyclophosphamide plus fludarabine regimen was followed by a single infusion of C-CAR066...One patient had grade 4 CRS and recovered after treatment with tocilizumab and corticosteroids... C-CAR066 has shown a favorable safety profile and promising efficacy in patients with r/r B-NHL following failure of CD19 CAR-T therapy . These results show that C-CAR066 has a different mechanism of action compared to anti-CD-19 CAR-T therapy and could provide a solution to address the unmet medical need in B-NHL patients that have failed anti-CD19 CAR-T therapy."

Clinical • Anemia • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • Transplantation • CD19 • CD20

CBMG Holdings' Novel Anti-CD20 CAR-T Cell Therapy Shows Promising Safety and Efficacy in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma Patients Following Relapse to an anti-CD19 CAR-T Therapy (PRNewswire) - P1, N=10; NCT04316624; "CBMG Holdings...announced early promising safety and efficacy results of C-CAR066, a novel second generation chimeric antigen receptor T (CAR-T) therapy targeting CD20 antigen in relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) that has failed to an anti-CD19 CAR-T therapy. Patients who fail anti-CD19 CAR-T therapy generally have a dismal prognosis and are an important group with high unmet medical needs...At a median follow-up of 4.2 months (range, 1.2-11.7), the best overall response rate was 100%, with 70.0% (7/10) reaching complete response (CR). Median time to response was 1.0 month (range, 0.9-2.7). Median time to CR was 2.7 months (range, 0.9-2.9)."

P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

CBMG Holdings Announces Data from Two CAR-T Clinical Studies Selected for Podium Presentations at ASCO Annual Meeting (PRNewswire) - “CBMG Holdings…announced the publication of two abstracts of CAR-T therapies for liquid tumors published in conjunction with the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held June 4-8, 2021...A phase I clinical trial was conducted to evaluate the safety and efficacy of C-CAR066 in subjects with r/r B-NHL who were previously treated with anti-CD19 CAR-T therapy. ”

Clinical data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Cellular Biomedicine Group Announces Data to be Presented at 2020 ASH Annual Meeting (PRNewswire) - "Cellular Biomedicine Group Inc...announced....that three abstracts relating to its immuno-oncology drug development have been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition to be held as a virtual event on December 5-8, 2020."

Clinical data • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Institute of Hematology & Blood Diseases Hospital

Clinical • New P1 trial