cemacabtagene ansegedleucel (ALLO-501A) / Allogene Therap, Cellectis - LARVOL DELTA

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL (Allogene Therapeutics Press Release) - "The Company achieved its 2026 goal of activating more than 80 sites approximately six months ahead of schedule, driven by strong execution and increased investigator interest following the interim futility analysis. The Company now expects approximately 100 sites to be active by year-end, with the significant majority in the United States and additional sites in Canada, Australia and South Korea....ALPHA3 is expected to randomize approximately 220 MRD+ patients to either cema-cel consolidation or close observation, with enrollment anticipated to be completed by year-end 2027. The next program update tied to the interim event-free survival (EFS) analysis is expected in mid-2027."

P2 data • Trial status • Large B Cell Lymphoma

Allogene Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to cemacabtagene ansegedleucel (cema-cel) for the treatment of adult patients with large B-cell lymphoma (LBCL) who, at the completion of first-line (1L) therapy (Allogene Therapeutics Press Release) - "The FDA granted RMAT designation for cema-cel as 1L consolidation therapy for patients with high-risk LBCL following full review of the interim futility analysis from the ongoing ALPHA3 trial, underscoring the continued need for new treatment options."

Fast track • FDA event • Diffuse Large B Cell Lymphoma • Large B Cell Lymphoma • Mediastinal B Cell Lymphoma

Allogene Therapeutics Expands Pivotal Phase 2 ALPHA3 Trial to South Korea and Australia (GlobeNewswire) - "Patient Screening and Enrollment Expected to Begin in Q2 2026...The study, currently enrolling across more than 60 sites in North America, will expand to over 80 global sites with the addition of South Korea and Australia. This growing trial footprint reflects strong interest in ALPHA3 from clinical trial sites...The ALPHA3 study is expected to enroll approximately 220 patients by the end of 2027. An interim analysis of event-free survival (EFS) is anticipated in mid-2027, followed by the primary EFS analysis in mid-2028."

P2 data • Trial status • Large B Cell Lymphoma

ALPHA3 Trial and Timeline (GlobeNewswire) - "The study is enrolling across more than 60 sites, with additional sites coming online, and is expected to enroll approximately 220 patients. Study accrual is anticipated to be complete by the end of 2027. The study is powered to detect a 50% reduction in the risk of EFS events. EFS events include the initiation of new anti-lymphoma therapy, disease progression, or death. The Company anticipates an interim EFS analysis in mid-2027 and the primary EFS analysis in mid-2028. If positive, these results could support a Biologics License Application (BLA) submission."

P2 data • Trial status • Large B Cell Lymphoma

Allogene Therapeutics Reports Interim Futility Analysis from Pivotal ALPHA3 Trial Showing 58.3% MRD Clearance with Cemacabtagene Ansegedleucel (Cema-Cel) vs. 16.7% in Observation Arm in First-Line Consolidation LBCL (GlobeNewswire) - "At the protocol-defined data cutoff, which was triggered when the 24th patient completed Day 45 MRD assessment, 58.3% (7/12) of patients in the cemacabtagene ansegedleucel (cema-cel) arm achieved minimal residual disease (MRD) negativity compared to 16.7% (2/12) in the observation arm. This represents a 41.6% absolute difference in MRD clearance between the two arms....In addition, at the first MRD assessment (Day 45), plasma ctDNA levels decreased from baseline by a median of 97.7% in the cema-cel arm compared to a 26.6% median increase in the observation arm."

P2 data • Large B Cell Lymphoma

Allogene Therapeutics to Announce Interim Futility Analysis Data from its Pivotal Phase 2 ALPHA3 Trial with Cemacabtagene Ansegedleucel (Cema-Cel) in First-Line Consolidation LBCL on Monday, April 13, 2026 (GlobeNewswire)

P2 data • Large B Cell Lymphoma

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL1 (GlobeNewswire) - "The trial is enrolling patients across more than 60 activated clinical trial sites, including sites outside the United States, spanning both academic and community cancer centers....The interim futility analysis in April 2026 will compare MRD clearance rates between cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation (12 patients in each cohort). The update will also include a summary of safety outcomes and additional information about screening and treatment patterns across the trial site footprint."

Enrollment status • P2 data • Large B Cell Lymphoma

ALPHA-2: Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2) (clinicaltrials.gov) - P1/2 | N=160 | Active, not recruiting | Sponsor: Allogene Therapeutics | Trial primary completion date: Aug 2025 ➔ Feb 2029

Trial primary completion date • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • BCL2

EXPAND: Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy (clinicaltrials.gov) - P2 | N=2 | Terminated | Sponsor: Allogene Therapeutics | N=70 ➔ 2 | Active, not recruiting ➔ Terminated; Terminated early for business reasons.

Enrollment change • Trial termination • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics Reports Favorable Result for Servier in Arbitration with Cellectis (GlobeNewswire) - "Arbitration ruling reaffirms Allogene’s full control of cemacabtagene ansegedleucel (cema-cel). Decision Reconfirms Allogene’s expanded sub-license covering EU and UK rights with options for Japan and China, clearing the path for Allogene to acquire full global rights."

Corporate lawsuit • Large B Cell Lymphoma

1H 2026 interim futility analysis from the pivotal phase 2 ALPHA3 trial with cema-cel in first-line (1L) consolidation Large B-Cell Lymphoma (LBCL) remains on track (GlobeNewswire)

P2 data • Large B Cell Lymphoma

Foresight Diagnostics Announces Multiple Presentations in Lymphoma Featuring PhasED-Seq Ultrasensitive MRD Analysis at the upcoming ASH Annual Meeting (PRNewswire)

Clinical data • Diagnostic • Classical Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Large B Cell Lymphoma • Marginal Zone Lymphoma

Sarah Cannon Research Institute to Present Research on Advances in Blood Cancers…at 2025 ASH Annual Meeting & Exposition (Sarah Cannon Research Institute (SCRI))

Clinical data • Acute Myelogenous Leukemia • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Myelodysplastic Syndrome • Waldenstrom Macroglobulinemia

Cellular Mechanisms Affecting Allogeneic CAR T Cell Expansion and Rejection in Large B-Cell Lymphoma (ASH 2023) - P1/2 | "We identified 11 patients with relapsed/refractory large B-cell lymphoma treated on the ALPHA-2 phase 1 trial (NCT04416984) with ALLO-501A, a healthy donor-derived CD19 CAR T with T cell receptor (TCR) knockout...We revealed the impact of recipient alloreactive CD8+ T cells in allogeneic CAR T rejection and identified expansion of identical allogeneic CAR T clonotypes with retained clonal hierarchy in multiple patients. While patient factors such as tumor burden and target antigen expression likely play a role as well, our results suggest that strategies to eliminate alloreactive recipient cells and enhance allogeneic CAR T fitness through improved product design, manufacturing and lymphodepletion could improve allogeneic CAR T expansion, persistence and efficacy."

CAR T-Cell Therapy • IO biomarker • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD4 • CD8

ALLO-647 for Lymphodepletion in the Allogeneic CAR T Setting: Safety Experience with ALLO-501/501A in Patients (Pts) with Relapsed/Refractory (r/r) Large B-Cell and Follicular Lymphomas (ASH 2023) - P1, P1/2 | "Updated phase 1 data for ALLO-501 (ALPHA; NCT03939026) and ALLO-501A (ALPHA2; NCT04416984) showed that administration of anti-CD19 allogeneic CAR T product following use of lymphodepletion that includes ALLO-647 plus fludarabine and cyclophosphamide provided durable responses and an acceptable safety profile in CAR T-cell–naive pts with r/r large B-cell lymphoma (LBCL; Locke FL, et al. These data suggest allogeneic CAR T-cell products administered following lymphodepletion consisting of FC and ALLO-647 can provide a safe and tolerable alternative to autologous CAR T-cell therapy."

Clinical • Anemia • B Cell Lymphoma • CNS Disorders • Cytomegalovirus Infection • Follicular Lymphoma • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Rare Diseases • Respiratory Diseases • Thrombocytopenia

Clinical Response after Allogeneic CAR T Cell Therapy Is Linked to Expansion of Identical CD8+ Effector-like T Cell Clones (ASH 2024) - P1/2 | "We identified patients with relapsed/refractory large B-cell lymphoma treated on the ALPHA-2 phase 1 trial (NCT04416984) with a single lot of ALLO-501A, a healthy donor-derived CD19 CAR T with T cell receptor (TCR) and CD52 knockout using Cellectis technologies...Moreover, our data highlight clones with effector-like molecular states as a key subset which could mediate antitumor responses to allogeneic CAR T cell products. These findings, as well as the presence of this phenotype in donor PBMCs prior to manufacturing, carry important implications for future development of these therapies."

CAR T-Cell Therapy • Clinical • IO biomarker • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD52 • CD8 • GZMH • GZMK • KLRG1 • NKG7

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL (GlobeNewswire) - "Additional sites in Australia and South Korea are progressing toward activation and are expected to open in early 2026. The next milestone will be the futility analysis comparing MRD conversion between the two arms comparing cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation, expected in the first half of 2026. At that time, the Company plans to share MRD conversion rates from the randomized portion of the study."

P2 data • Trial status • Large B Cell Lymphoma

Allogene Therapeutics…announced that a Trial-in-Progress (TIP) poster highlighting the pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (cema-cel) will be presented at the 2025 American Society of Hematology (ASH) Annual Meeting… (GlobeNewswire) - "The poster will highlight the innovative design of the ongoing pivotal Phase 2 ALPHA3 trial evaluating cema-cel as part of a first line (1L) consolidation strategy in patients with large B-cell lymphoma (LBCL) who remain minimal residual disease (MRD) positive at the completion of 1L chemoimmunotherapy....A futility analysis comparing MRD conversion between the two arms is expected to occur 1H 2026."

Clinical protocol • P2 data • Large B Cell Lymphoma

Best of Cell Therapy for Lymphoma: What We Learned in 2024 and 2025 (SOHO 2025) - P1/2, P2 | "Autologous CAR-T Therapy CD19 CAR-T New Regulatory Approvals In March 2024, the United States Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel (lisocel) for relapsed/refractory (R/R) chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) after Bruton tyrosine kinase inhibitors (BTKis) and B-cell lymphoma 2 (BCL2) inhibitors, making it the first CAR-T approval in this disease...Long-Term Follow-up of Pivotal CD19 CAR-T Trials TRIAL (PRODUCT) LYMPHOMA SUBTYPE MEDIAN FU (MONTHS) ORR (%) CR (%) MEDIAN PFS (MONTHS) PFS (%) OS (%) NOTABLE SAFETY FINDINGS 64.6 90 75 (79% in FL cohort, 65% in MZL cohort) 62.2 53 (5 yr) 69 (5 yr) No new late signals ZUMA-5 (AXICEL) FL/MZL ( ≥ 3L) ELARA (TISA-CEL) FL ( ≥ 3L) 53 – * 69.1 53.3 50.2 (4 yr) 79.3 (4 yr) No new late signals; 6.2% secondary primary malignancies TRANSCEND FL (LISO-CEL) FL (2L+ high-risk/3L+) 29.5 – 30 95.7 – 97.1 94.2 – 95.7 NR 72.5 – 82.6 (2 yr) 88.2 –..."

IO biomarker • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hodgkin Lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Oncology • Peripheral T-cell Lymphoma • Small Lymphocytic Lymphoma • T Cell Non-Hodgkin Lymphoma • CD22 • CD5 • IL15 • TNFRSF8

Allogene Therapeutics Moves Forward with Standard Fludarabine and Cyclophosphamide (FC) Lymphodepletion Regimen in the ALPHA3 Trial for Cemacabtagene Ansegedleucel (Cema-Cel) in First-Line Consolidation for Large B-Cell Lymphoma (GlobeNewswire) - "Allogene...announced that it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study...This lymphodepletion regimen selection was made in conjunction with the ALPHA3 Data and Safety Monitoring Board (DSMB) and Steering Committee and following consultation with the U.S. Food and Drug Administration (FDA)...The arm testing FC plus ALLO-647, an anti-CD52 mAb (FCA), is now closed to further enrollment. This decision, made ahead of the scheduled futility analysis, was prompted by a Grade 5 adverse event in the FC plus ALLO-647 arm that has been attributed to the use of ALLO-647...The adoption of standard FC in the ALPHA3 trial marks a key shift in Allogene’s clinical strategy. As a result, no trials open to enrollment or pipeline programs include ALLO-647....The next milestone will be the futility analysis comparing MRD conversion and is expected to occur 1H 2026."

Discontinued • DSMB • Trial status • Large B Cell Lymphoma

Allogene Therapeutics Announces ASCO 2025 Abstract Publication Featuring Oral Presentation of ALLO-316 in Kidney Cancer and ALPHA3 TIP Poster for Cema-Cel (PRNewswire) - "An oral presentation will feature ALLO-316, an investigational AlloCAR T product targeting CD70....The upcoming presentation will share updated data from the Phase 1 TRAVERSE study with a focus on the Phase 1b expansion cohort in which patients were treated with a standard regimen of cyclophosphamide and fludarabine followed by a single dose of 80 million CAR T cells. In addition, a Trial-in-Progress (TIP) poster will highlight the innovative design of the ongoing pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (cema-cel) as part of a first line (1L) consolidation strategy in patients with large B-cell lymphoma (LBCL) who remain minimal residual disease (MRD) positive at the completion of 1L chemoimmunotherapy."

Clinical protocol • P1 data • Clear Cell Renal Cell Carcinoma • Large B Cell Lymphoma

Pivotal Phase 2 ALPHA3 Trial with Cemacabtagene Ansegedleucel (Cema-Cel) in First Line (1L) Consolidation in Large B-Cell Lymphoma (LBCL) (GlobeNewswire) - "Nearly 50 Sites Activated Across U.S. with Strong Enthusiasm from Investigators. Lymphodepletion Selection and Futility Analysis Shifted to 1H 2026 in Part Due to Site-Related. Factors that Impacted Expected Pace of Screening Immediately Following Site Activation. Over 250 Patients Consented for MRD Screening to Date, with Nearly Half in the Last Three Months and Awaiting Completion of 1L Treatment as Earliest Activated Sites Build Momentum. International Expansion of ALPHA3 Trial to Begin with Site Activations in Canada in Q2 2025."

P2 data • Trial status • Large B Cell Lymphoma

Allogene Therapeutics to Present Updated ALLO-316 Clinical Results in Kidney Cancer in Oral Presentation and ALPHA3 Trial-in-Progress Poster for Cema-Cel at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "Allogene Therapeutics...announced that it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting....In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel (cema-cel) as part of first-line (1L) treatment for patients with large B-cell lymphoma (LBCL)."

P1 data • Trial status • Large B Cell Lymphoma • Renal Cell Carcinoma

Cema-Cel: Pivotal ALPHA3 1L Consolidation Trial in LBCL (GlobeNewswire) - "The lymphodepletion selection and futility analysis are anticipated around mid-2025. Efficacy analyses from the ALPHA3 trial are expected to occur in 2026 and will include an interim EFS analysis monitored by the independent Data Safety Monitoring Board (DSMB) in 1H 2026 and the data readout of the primary EFS analysis around YE 2026. A potential biologics license application (BLA) submission is targeted for 2027."

DSMB • FDA filing • P2 data • Large B Cell Lymphoma

Allogene Therapeutics Expands Strategic Partnership with Foresight Diagnostics to Advance Joint Development Activities Outside the US Across Europe, UK, Canada, and Australia (GlobeNewswire) - "Allogene Therapeutics...announced an expanded strategic collaboration with Foresight Diagnostics, Inc. to include the development of Foresight’s minimal residual disease (MRD) assay as a companion diagnostic to identify patients with large B-cell lymphoma (LBCL) for treatment with cemacabtagene ansegedleucel (cema-cel). Under the Amended and Restated Strategic Collaboration Agreement, Allogene and Foresight will work together to support the development of Foresight Diagnostics’ MRD assay as a companion diagnostic in the EU, UK, Canada and Australia in support of Allogene’s clinical development of cema-cel....In the ALPHA 3 trial, patients who achieve remission following initial treatment but remain positive for MRD will be identified by using Foresight Diagnostics’ ultra-sensitive ctDNA-based Foresight CLARITY investigational use only (IUO) assay, powered by PhasED-Seq."

Diagnostic • Licensing / partnership • Large B Cell Lymphoma