vispacabtagene regedleucel (CB-010) / Caribou Biosci - LARVOL DELTA

Vispa-Cel, an Allogeneic Anti-CD19 CAR-T Therapy With a PD-1 Knockout, in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ANTLER Phase 1 Clinical Trial) (SOHO 2026) - P1 | "Objectives: Vispacabtagene regedleucel (vispa-cel, CB-010) is an allogeneic anti-CD19 CAR-T therapy manufactured from healthy donors...Design: Patients received lymphodepletion of sequential cyclophosphamide (60 mg/kg/day × 2 days) then fludarabine (25 mg/m2/day × 5 days) followed by a single vispa-cel infusion of 40 million (M), 80 M, or 120 M cells... Vispa-cel demonstrates deep, durable responses in 2L LBCL, on par with approved autologous CAR-T therapies, with well-tolerated safety. A randomized pivotal trial is planned for 2L LBCL patients not eligible for transplant and not candidates or not eligible for autologous CAR-T therapy based on access challenges or medical criteria, including the need for urgent therapy. 2L LBCL: second-line large B-cell lymphoma, CAR-T: chimeric antigen receptor T-cell, CD19: cluster of differentiation 19, chRDNA: chemically modified RNADNA hybrid, CR: complete response, CRS: cytokine release syndrome, DoR: duration of..."

CAR T-Cell Therapy • Clinical • P1 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • PD-1

VISPA-CEL, AN ALLOGENEIC ANTI-CD19 CAR-T CELL THERAPY WITH A PD-1 KNOCKOUT, IN PATIENTS WITH RELAPSED/REFRACTORY B CELL NON-HODGKIN LYMPHOMA (ANTLER PHASE 1 CLINICAL TRIAL) (EHA 2026) - P1 | "Background Vispacabtagene regedleucel (vispa-cel, formerly CB-010) is an allogeneic anti-CD19 CAR-T cell therapy manufactured from healthy donor T cells...Methods All pts received lymphodepletion of sequential cyclophosphamide (60 mg/kg/day x 2 days) then fludarabine (25 mg/m2/day x 5 days) followed by a single infusion of vispa-cel...Improved PFS was observed in pts treated with vispa-cel manufactured from young donors (<30 yrs) and ≥2 matched HLA alleles. A randomized controlled pivotal trial in 2L LBCL pts who are ineligible for both autologous CAR-T and transplant is being planned."

CAR T-Cell Therapy • Clinical • P1 data • Acute Respiratory Distress Syndrome • B Cell Non-Hodgkin Lymphoma • CNS Disorders • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Rare Diseases • Respiratory Diseases • Thrombocytopenia • PD-1

Caribou previously reached alignment with the U.S. Food and Drug Administration (FDA) regarding its planned ANTLER-3 pivotal phase 3 clinical trial design… (GlobeNewswire) - "ANTLER-3...is expected to be a randomized, controlled clinical trial enrolling approximately 250 CD19-naïve 2L LBCL patients who are not eligible for transplant and not candidates or not eligible for autologous CAR-T cell therapy based on access challenges or medical criteria, including the urgent need for therapy."

FDA event • New P3 trial • Large B Cell Lymphoma

ANTLER phase 1 efficacy and safety data (GlobeNewswire) - "The results are being presented during an oral presentation at the 2026 European Hematology Association (EHA) Annual Meeting....As of the March 6, 2026, data cutoff date, 27 second-line (2L) large B cell lymphoma (LBCL) patients had received a single dose of 80 million optimized vispa-cel CAR-T cells. Vispa-cel continues to demonstrate a generally well-tolerated safety profile. In the pivotal optimized vispa-cel subgroup (N=27), there were no reports of graft-versus-host disease (GvHD) or grade 3 or higher (≥Gr 3) immune effector cell-associated neurotoxicity syndrome (ICANS), and there was one (4%) ≥Gr 3 cytokine release syndrome (CRS)."

Cytokine release syndrome • P1 data • Large B Cell Lymphoma

Caribou Biosciences to Highlight Vispa-cel and CB-011 Programs During Oral Presentations at the 2026 European Hematology Association (EHA) Annual Meeting (StockTitan.net) - "Caribou Biosciences (Nasdaq: CRBU) will feature its allogeneic CAR-T programs vispa-cel and CB-011 in oral presentations at the 2026 European Hematology Association Annual Meeting in Stockholm, June 11-14, 2026. Presentations cover ANTLER and CaMMouflage phase 1 trials in lymphoma and multiple myeloma"

P1 data • Multiple Myeloma • Non-Hodgkin’s Lymphoma

Vispa-Cel, an Allogeneic Anti-CD19 CAR-T cell Therapy with a PD-1 Knockout, In Patients with relapsed/refractory B cell Non-Hodgkin Lymphoma (r/r B-NHL): Updated Results from the Antler Phase 1 Clinical Trial (TCT-ASTCT-CIBMTR 2026) - P1 | "Introduction: Vispacabtagene regedleucel (vispa-cel, formerly CB-010) is an allogeneic anti-CD19 CAR-T cell therapy manufactured from healthy donor T cells...All pts received lymphodepletion of sequential cyclophosphamide (60 mg/kg/day x 2 days) then fludarabine (25 mg/m2/day x 5 days) followed by a single infusion of vispa-cel... Vispa-cel is an allogeneic CAR-T cell therapy that results in deep and durable responses on par with approved autologous CAR-T cell therapies in 2L LBCL pts with a generally well-tolerated safety profile supporting outpatient administration. Improved PFS was observed in pts treated with vispa-cel manufactured from young donors and ≥2 matched HLA alleles. A randomized controlled pivotal trial in 2L LBCL pts who are ineligible for both autologous CAR-T and transplant is being planned."

CAR T-Cell Therapy • Clinical • Late-breaking abstract • P1 data • B Cell Non-Hodgkin Lymphoma • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • PD-1

Caribou Biosciences Announces Late-Breaking Presentations at the 2026 Tandem Meetings of ASTCT and CIBMTR (The Manila Times) - "Clinical data disclosed in November 2025 will be presented with new supportive translational data in a poster presentation on the vispa-cel ANTLER phase 1 clinical trial in relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) and in an oral presentation on the ongoing CB-011 CaMMouflage phase 1 clinical trial in relapsed or refractory multiple myeloma (r/r MM)."

P1 data • Multiple Myeloma • Non-Hodgkin’s Lymphoma

Caribou Biosciences to Host In-Person and Virtual KOL Event at ASH 2025 (GlobeNewswire) - "KOL panel to discuss how vispa-cel, an anti-CD19 allogeneic CAR-T cell therapy, can broaden access for patients with second-line large B cell lymphoma including through use in the community setting."

Clinical data • Large B Cell Lymphoma

Caribou Biosciences Announces Positive Data from ANTLER Phase 1 Trial Demonstrating Efficacy and Durability of Vispa-cel (CB-010), an Allogeneic CAR-T Cell Therapy, on Par with Autologous CAR-T Cell Therapies (Caribou Bio Press Release) - "Data from this 35-patient cohort further confirmed that the efficacy and durability of vispa-cel are on par with the autologous CAR-T cell therapies. Median follow-up for the optimized profile cohort was 11.8 months, and the longest responding patient, who completed the 2-year ANTLER trial and enrolled in the long-term follow-up study, is in complete response at 3 years post infusion....In all patients treated in ANTLER (N=84), vispa-cel has demonstrated a generally well-tolerated safety profile. As of the September 2, 2025, safety data cutoff date, treatment emergent adverse events at any grade in ≥25% of all patients who received vispa-cel were thrombocytopenia (62%), cytokine release syndrome (CRS; 55%), anemia (52%), neutropenia (39%), hypokalemia (26%), and leukopenia (26%)."

P1 data • B Cell Non-Hodgkin Lymphoma

Caribou Biosciences…announced that it will hold a webcast beginning at 8:00 am ET on Monday, November 3, 2025… (GlobeNewswire) - "Caribou Biosciences...to report new data from the ANTLER phase 1 clinical trial evaluating vispacabtagene regedleucel (vispa-cel; formerly CB-010), an allogeneic anti-CD19 CAR-T cell therapy, in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) and report the first clinical data from the CaMMouflage Phase 1 clinical trial evaluating CB-011, an allogeneic anti-BCMA CAR-T cell therapy, in patients with r/r multiple myeloma. The Company will also report its anticipated pivotal phase 3 trial design for vispa-cel and next steps for the continued clinical development of CB-011."

New P3 trial • P1 data • B Cell Non-Hodgkin Lymphoma • Multiple Myeloma

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP) (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Caribou Biosciences, Inc. | N=20 ➔ 0 | Initiation date: Jun 2025 ➔ Dec 2027 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial initiation date • Trial withdrawal • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Pipeline prioritization with workforce and cost reduction initiatives (GlobeNewswire) - "Caribou is discontinuing the GALLOP Phase 1 trial of CB-010 for lupus prior to dosing the first patient."

Trial termination • Systemic Lupus Erythematosus

Caribou Biosciences Announces Strategic Pipeline Prioritization with Focus on CB-010 and CB-011 Oncology Programs (GlobeNewswire) - "Clinical highlights:...Caribou is enrolling a 20-patient confirmatory cohort using the company’s HLA matching strategy in the ANTLER Phase 1 clinical trial in second-line large B cell lymphoma (2L LBCL). In H2 2025, Caribou expects to present data from this cohort with at least 6 months of follow up for the majority of patients....Additionally, in H2 2025, Caribou expects to present data from a proof-of-concept cohort of CB-010 in up to 10 patients who have relapsed following any prior CD19-targeted therapy....Caribou...is interacting with the FDA on a potential pivotal trial to be initiated following alignment....Pivotal trial design and timeline, contingent on positive data and FDA alignment."

FDA event • P1 data • Large B Cell Lymphoma • Non-Hodgkin’s Lymphoma

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients with Refractory Systemic Lupus Erythematosus (GALLOP) (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Caribou Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Caribou Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "2025 anticipated milestones:...CB-010 GALLOP: Caribou plans to provide updates as the GALLOP Phase 1 clinical trial in LN and ERL advances."

P1 data • Lupus • Lupus Nephritis

Caribou Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "2025 anticipated milestones: (i) CB-010 ANTLER: Caribou plans to present data from both the additional 2L and prior CD19 relapsed LBCL patient cohorts in H1 2025. Caribou plans to initiate a pivotal Phase 3 clinical trial in H2 2025 should data confirm the initial observation that partial HLA matching drives outcomes that are on par with autologous CAR-T cell therapies. The Phase 3 trial would be initiated after agreement with the FDA on a pivotal trial design; (ii) CB-011 CaMMouflage: Caribou plans to present dose escalation data on a minimum of 15 patients at active dose levels from the ongoing CaMMouflage Phase 1 clinical trial in r/r MM in H1 2025; (iii) CB-012 AMpLify: Caribou plans to provide updates on dose escalation as the AMpLify Phase 1 clinical trial in r/r AML advances."

New P3 trial • P1 data • Acute Myelogenous Leukemia • Large B Cell Lymphoma • Multiple Myeloma

Caribou Biosciences Initiates the CB-010 GALLOP Phase 1 Trial in Lupus and Provides Outlook for Multiple Clinical Datasets in 2025 (GlobeNewswire) - "Caribou has initiated the GALLOP Phase 1 clinical trial, an open-label, multicenter clinical trial designed to evaluate a single infusion of CB-010 in adult patients with LN and ERL."

Trial status • Lupus • Lupus Nephritis

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients with Refractory Systemic Lupus Erythematosus (GALLOP) (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Caribou Biosciences, Inc.

New P1 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Preclinical Analysis of CB-010, an Allogeneic anti-CD19 CAR-T Cell Therapy with a PD-1 Knockout, for the Treatment of Patients with Refractory Systemic Lupus Erythematosus (SLE) (ACR Convergence 2024) - P1 | "CB-010, an off-the-shelf CAR-T cell therapy, demonstrated specific B cell targeting in preclinical studies both in vitro and in vivo. The combination of these preclinical data, with a generally well tolerated clinical safety profile and encouraging efficacy from the ongoing ANTLER clinical trial, support the evaluation of CB-010 in a Phase 1 clinical trial for refractory LN and ERL patients (GALLOP). Two patient cohorts (one each in LN and ERL) will be enrolled in parallel using lymphodepletion with fludarabine and cyclophosphamide followed by a single CB-010 infusion of 80 x 106 CAR-T cells (see Figure 3)."

CAR T-Cell Therapy • IO biomarker • Preclinical • Glomerulonephritis • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Systemic Lupus Erythematosus • CD34 • PD-1

Caribou Biosciences Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Anticipated milestones: (i) CB-010 ANTLER: Caribou plans to present data from both the additional 2L and prior CD19 relapsed LBCL patient cohorts in H1 2025; (ii) Caribou plans to initiate a pivotal Phase 3 clinical trial in H2 2025 should data confirm the initial observation that partial HLA matching is associated with improved outcomes for patients."

New P3 trial • P1 data • Non-Hodgkin’s Lymphoma

Caribou Biosciences to Present Preclinical Data Supporting Development of CB-010 for Lupus at the American College of Rheumatology Convergence 2024 (GlobeNewswire) - "Caribou Biosciences, Inc...announced an abstract has been accepted for a poster presentation at the American College of Rheumatology (ACR) Convergence 2024, which will be held November 14-19, 2024 in Washington, DC. The poster will highlight the preclinical data and key elements of the clinical trial design that supported the investigational new drug (IND) clearance to evaluate CB-010 in the GALLOP Phase 1 clinical trial in patients with lupus nephritis (LN) and extrarenal lupus (ERL)."

Clinical protocol • Preclinical • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus

Caribou Biosciences Announces the FDA has Granted Fast Track Designations... (GlobeNewswire) - "Caribou Biosciences...today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designations to CB-010 for refractory systemic lupus erythematosus (SLE)....CB-010, an allogeneic anti-CD19 CAR-T cell therapy, will be evaluated in the GALLOP Phase 1 clinical trial in patients with lupus nephritis (LN) and extrarenal lupus (ERL), subcategories of SLE. The GALLOP clinical trial is on track to initiate by year-end 2024."

Fast track • New P1 trial • Lupus • Systemic Lupus Erythematosus

Caribou Biosciences Reports Second Quarter 2024 Financial Results and Provides Business Update (Caribou Bio Press Release) - "CB-010: Caribou also is enrolling a cohort of up to 10 patients who have relapsed following any prior CD19-targeted therapy in a proof-of-concept cohort in this population of unmet need. This cohort will also incorporate partial HLA matching between donors and patients; Caribou plans to initiate a pivotal Phase 3 trial in the second half of 2025, should data confirm improved outcomes for patients receiving a partially HLA matched dose of CB-010 and following agreement with the FDA on a pivotal trial design."

New P3 trial • Trial status • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Caribou cuts NK cell therapy program, lays off 12% of staff to fund CAR-T priorities (FierceBiotech) - "The CAR-NK program, dubbed CB-020, was an induced pluripotent stem cell (iPSC)-derived allogeneic anti-ROR 1 cell therapy aimed at solid tumors. Caribou already revealed in March that it had paused work on the program as part of a 'regular portfolio prioritization process...With the NK plans now abandoned altogether, the biotech can focus its resources on its allogeneic CAR-T platform, which Caribou noted yesterday has 'multiple milestones expected in 2024 and 2025' across its oncology and autoimmune arms...These include presenting initial dose escalation data for CB-011 in relapsed or refractory multiple myeloma by the end of this year, as well as launching a phase 1 trial of its lead asset CB-010—which is already being tested in B cell lymphoma—in lupus."

Discontinued • New P1 trial • P1 data • Lupus • Multiple Myeloma • Solid Tumor

A CRISPR-EDITED ALLOGENEIC ANTI-CD19 CAR-T CELL THERAPY WITH A PD-1 KNOCKOUT (CB-010) FOR RELAPSED/REFRACTORY B CELL NON-HODGKIN LYMPHOMA (R/R B-NHL): UPDATED PHASE 1 RESULTS FROM THE ANTLER TRIAL (EHA 2024) - P1 | "Pts underwent lymphodepletion with sequential cyclophosphamide (60mg/kg/day x 2 days) and fludarabine (25 mg/m2/day x 5 days) followed by a single CB-010 infusion. CB-010 showed a manageable safety profile and promising efficacy for the treatment of pts with r/r B-NHL,including those with aggressive subtypes. The dose escalation phase is complete and enrollment of 2L LBCL ptsin the dose expansion phase is ongoing. Initial dose expansion data at the CB-010 RP2D and translational datawill be presented at the meeting."

CAR T-Cell Therapy • IO biomarker • P1 data • Anemia • Dermatology • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • PD-1