LMY-920 / Luminary Therap - LARVOL DELTA

Safety and efficacy of transposon, BAFF-ligand directed chimeric antigen receptor T cells (LMY-920) with pre-apheresis obinutuzumab for patients with Relapsed/Refractory chronic lymphocytic leukemia and small lymphocytic lymphoma (ASH 2025) - P1 | "Anti-CD19 CAR T cells show modestactivity in CLL, with lisocabtagene maraleucel demonstrating only 57% overall response and 18%complete response rates in BTK/BCL2 inhibitor-treated patients...Key exclusion criteriainclude CNS involvement, active malignancy, cardiovascular instability, active infection, and autoimmunedisease requiring immunosuppression.The treatment protocol involves: (1) pre-apheresis B cell depletion with obinutuzumab (100mg day 1,900mg day 2) starting 14-21 days before leukapheresis; (2) standard leukapheresis and LMY-920manufacturing over 8-11 days using transposon technology; (3) lymphodepletion with fludarabine (30mg/m²/day) and cyclophosphamide (500 mg/m²/day) for 3 days beginning on day -5; and (4) LMY-920infusion on day 0 at escalating doses from 2×10⁶ to 8×10⁶ BAFF CAR-T cells/kg... Targeting ubiquitously expressed BAFF receptors with optimization of the starting T cellmaterial through pre-apheresis B cell depletion for..."

CAR T-Cell Therapy • Clinical • IO biomarker • Chronic Lymphocytic Leukemia • Gene Therapies • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Small Lymphocytic Lymphoma

Phase 1 assessment of novel transposon BAFF CAR-T cells (LMY-920) for non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) (ASH 2025) - P1 | "Patients then receive lymphodepleting chemotherapy (fludarabine (30 mg/m2/d x 3) andcyclophosphamide (500 mg/m2/d x 3). Given the hypothesized advantages of targeting BAFFreceptors, enrolled patients have included those having received prior idecabtagene vicleucel (anti-BCMA) CAR-T cells, axicabtagene ciloleucel (anti-CD19) CAR-T cells, as well as anti-CD20 antibodies andbispecific antibodies, with lymphoma cells demonstrating CD19 and/or CD20 antigen loss. Clinical trialsare also being conducted to assess LMY-920 in patients with CLL and autoimmune disease (systemiclupus erythematosus)."

CAR T-Cell Therapy • P1 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Immunology • Inflammatory Arthritis • Leukemia • Lupus • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Systemic Lupus Erythematosus

Transposon-based BAFF CAR-T cells (LMY-920) for treatment of Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Lymphoma (CLL), and Multiple Myeloma (MM) (AACR-NCI-EORTC 2025) - P1 | " In parallel protocols NCT05312801, NCT05546723 and NCT06916767 patients undergo leukapheresis (CLL patients receive obinutuzumab prior to leukapheresis) and LMY-920 CAR-T cells manufactured using the BAFF-CAR transposon construct. Patients then receive fludarabine (30 mg/m2/d) and cyclophosphamide (500 mg/m2/d) lymphodepletion for 3 days...Further, one of the DLBCL patients in complete response had received prior axicabtagene ciloleucel (anti-CD19) CAR-T cells as well as anti-CD20 bispecific antibodies, with lymphoma cells resulting in CD19 and CD20 antigen loss... This study demonstrates successful use of a novel transposon-engineered BAFF ligand-based CAR-T cell product. Excellent safety and efficacy were observed, including in patients with challenging clinical scenarios such as PCL, prior CAR-T failure and epitope loss, as hypothesized. This product is also being evaluated in a clinical trial in systemic lupus erythematosus (NCT06340750)."

CAR T-Cell Therapy • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Plasma Cell Leukemia

Transposon-Based BAFF CAR-T cells (LMY-920) for Treatment of Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Lymphoma (CLL) and Multiple Myeloma (MM) (AACR-NCI-EORTC 2025) - P1 | " In parallel protocols NCT05312801, NCT05546723 and NCT06916767 patients undergo leukapheresis (CLL patients receive obinutuzumab prior to leukapheresis) and LMY-920 CAR-T cells manufactured using the BAFF-CAR transposon construct. Patients then receive fludarabine (30 mg/m2/d) and cyclophosphamide (500 mg/m2/d) lymphodepletion for 3 days...Further, one of the DLBCL patients in complete response had received prior axicabtagene ciloleucel (anti-CD19) CAR-T cells as well as anti-CD20 bispecific antibodies, with lymphoma cells resulting in CD19 and CD20 antigen loss... This study demonstrates successful use of a novel transposon-engineered BAFF ligand-based CAR-T cell product. Excellent safety and efficacy were observed, including in patients with challenging clinical scenarios such as PCL, prior CAR-T failure and epitope loss, as hypothesized. This product is also being evaluated in a clinical trial in systemic lupus erythematosus (NCT06340750)."

CAR T-Cell Therapy • Late-breaking abstract • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Plasma Cell Leukemia

Transposon-Based BAFF CAR-T cells (LMY-920) for Treatment of Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Lymphoma (CLL) and Multiple Myeloma (MM) (SITC 2025) - P1 | "Patients then receive fludarabine (30 mg/m2/d) and cyclophosphamide (500 mg/m2/d) lymphodepletion for 3 days...Further, one of the DLBCL patients in complete response had received prior axicabtagene ciloleucel (anti-CD19) CAR-T cells as well as anti-CD20 bispecific antibodies, with lymphoma cells resulting in CD19 and CD20 antigen loss.Conclusions This study demonstrates successful use of a novel transposon-engineered BAFF ligand-based CAR-T cell product...This product is also being evaluated in a clinical trial in systemic lupus erythematosus (NCT06340750).Acknowledgements Branden S. Moriarity and Beau R. Webber co-directed this work.Trial Registration NCT05546723, NCT05312801, NCT06916767Ethics Approval The study obtained ethics approval from Case Comprehensive Cancer Center, Cleveland Clinic's Institutional Review Board (24-424/MOD01553645), and participants gave informed consent before taking part.Consent Written informed consent was obtained from the..."

CAR T-Cell Therapy • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Plasma Cell Leukemia

Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma. Substudy B: CLL Patients (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Paolo Caimi, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

LMY-920-003: BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Luminary Therapeutics | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jan 2026 ➔ Apr 2026

Enrollment open • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma. Substudy B: CLL Patients (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Paolo Caimi, MD

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

Transposon-Based BAFF CAR T Cells Show Early Efficacy, Safety in R/R Non-Hodgkin Lymphoma (OncLive) - P1 | N=20 | NCT05312801 | Sponsor: Luminary Therapeutics | "Transposon-engineered BAFF ligand–based CAR T cells (LMY-920) induced responses with a tolerable safety profile among 3 patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL), according to data from a phase 1 trial (NCT05312801) presented at the 2024 SITC Annual Meeting...Data from the trial reveal that a single grade 1 cytokine release syndrome (CRS) event was reported among the 3 patients, with no immune effector-cell associated neurotoxicity syndrome (ICANS) incidence reported. Additionally, a complete response was observed in one patient with transformed follicular lymphoma. A mixed response, characterized by a decrease in FDG uptake and a decrease in size of all lesions, and stable disease were recorded among 2 other patients with mantle cell lymphoma (MCL). Furthermore, one grade 2 incident of COVID-19 infection was observed in a 55-year-old patient with MCL."

Cytokine release syndrome • P1 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A phase 1 study of novel transposon-based BAFF CAR-T cells (LMY-920) for treatment of relapsed or refractory non-hodgkin lymphoma (NHL) (SITC 2024) - P1 | "Patients are lympodepleted with fludarabine (30 mg/m2/d) and cyclophosphamide (500 mg/m2/d) for 3 days. This product is also being evaluated in clinical trials targeting myeloma (NCT05546723) and systemic lupus erythematosus (NCT06340750). Ethics Approval The study obtained ethics approval from Cleveland Clinic's Institutional Review Board (24–424/MOD01553645), and participants gave informed consent before taking part."

CAR T-Cell Therapy • IO biomarker • P1 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD19

A phase 1 study of novel transposon-based BAFF CAR-T cells (LMY-920) for treatment of relapsed or refractory non-hodgkin lymphoma (NHL) (SITC 2024) - P1 | "Patients are lympodepleted with fludarabine (30 mg/m2/d) and cyclophosphamide (500 mg/m2/d) for 3 days. This product is also being evaluated in clinical trials targeting myeloma (NCT05546723) and systemic lupus erythematosus (NCT06340750). Ethics Approval The study obtained ethics approval from Cleveland Clinic's Institutional Review Board (24–424/MOD01553645), and participants gave informed consent before taking part."

CAR T-Cell Therapy • IO biomarker • P1 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD19

LMY-920-003: BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Luminary Therapeutics | Initiation date: Jun 2024 ➔ Jan 2025 | Trial primary completion date: Oct 2025 ➔ Jan 2026

CAR T-Cell Therapy • Trial initiation date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Multiple Myeloma Patients at UH Seidman Cancer Center Have New Immunotherapy Option (University Hospitals) - "A Phase I BAFF CAR T clinical trial for patients with relapsed and refractory multiple myeloma is now underway at UH Seidman Cancer Center...This study is being done through an agreement between University Hospitals and Luminary Therapeutics, a biotech start-up based in Minneapolis...The new multiple myeloma trial at UH Seidman will proceed with up to 20 patients with relapsed or refractory myeloma and three or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody....Its primary goal is to determine the maximum tolerated dose and recommended dose of BAFF CAR T-cells for a Phase II trial. Secondary objectives include establishing the toxicity profile, objective response rate, complete response rate, duration of response, progression-free survival, overall survival, the incidence of adverse events and the incidence of antibodies against the BAFF CAR T-cells. Dr. Metheny and the team will collect data..."

Licensing / partnership • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Luminary Therapeutics

CAR T-Cell Therapy • New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

LMY-920-002: LMY-920 for Treatment of Relapsed or Refractory Myeloma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Luminary Therapeutics | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Luminary Therapeutics Announces FDA Clearance of Phase I, IND for a BAFF CAR to Treat Systemic Lupus Erythematosus (SLE) (EIN News) - "Luminary Therapeutics...announced the clearance of its first Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of LMY-920 (A BAFF CAR), a novel therapy for the treatment of systemic lupus erythematosus (SLE)."

IND • New P1 trial • Immunology • Systemic Lupus Erythematosus

LMY-920-002: LMY-920 for Treatment of Relapsed or Refractory Myeloma (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Luminary Therapeutics | Trial completion date: Dec 2024 ➔ Oct 2025 | Trial primary completion date: Oct 2024 ➔ Jul 2025

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Luminary Therapeutics | Trial completion date: Sep 2024 ➔ Sep 2025 | Trial primary completion date: Jun 2024 ➔ May 2025

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

Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Luminary Therapeutics | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2022 ➔ Jan 2023

CAR T-Cell Therapy • Enrollment open • Trial initiation date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

LMY-920-002: LMY-920 for Treatment of Relapsed or Refractory Myeloma (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Luminary Therapeutics | Initiation date: Nov 2022 ➔ Feb 2023

CAR T-Cell Therapy • Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

LMY-920-002: LMY-920 for Treatment of Relapsed or Refractory Myeloma (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Luminary Therapeutics

CAR T-Cell Therapy • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Luminary Therapeutics | Initiation date: May 2022 ➔ Oct 2022

CAR T-Cell Therapy • Trial initiation date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Luminary Therapeutics

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