ATA3219 / Atara - LARVOL DELTA

ATA3219-NHL-103: A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=1 | Terminated | Sponsor: Atara Biotherapeutics | N=40 ➔ 1 | Trial completion date: Nov 2028 ➔ Mar 2025 | Recruiting ➔ Terminated | Trial primary completion date: May 2026 ➔ Mar 2025; Financial reasons

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

ATA3219-AEC-104: A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Atara Biotherapeutics | N=52 ➔ 0 | Trial completion date: Apr 2029 ➔ Apr 2025 | Initiation date: Nov 2024 ➔ Apr 2025 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Oct 2027 ➔ Apr 2025

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

Preclinical and Clinical Development of ATA3219, a Novel Allogeneic CD19 CAR EBV T cell Therapy for the Treatment of Patients with Systemic Lupus Erythematosus (EULAR 2025) - No abstract available

Preclinical • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Atara Biotherapeutics Announces Fourth Quarter and Full Year 2024 Financial Results and Operational Progress (Businesswire) - "...'The Company has made the difficult decision to pause development of its allogeneic CAR-T cell programs and to discontinue all CAR-T operations including terminating the clinical trials evaluating ATA3219'....Atara remains focused on delivering on the future financial value of EBVALLO and has paused ATA3219 and ATA3431 CAR-T programs..."

Discontinued • Hematological Malignancies

Atara Biotherapeutics Provides Update on Clinical Programs Related to…ATA3219 (Businesswire) - "Atara Biotherapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Atara’s active Investigational New Drug (IND) applications. These INDs include...ATA3219, an allogeneic CD19-targeted CAR-T therapy, for the treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus....ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the CRL....Atara and FDA have discussed and agreed upon the actions necessary to release the clinical holds. The FDA has confirmed its commitment to working collaboratively and expeditiously with Atara to resolve the clinical holds."

FDA event • Non-Hodgkin’s Lymphoma • Systemic Lupus Erythematosus

ATA3219-NHL-103: A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Atara Biotherapeutics | Initiation date: Jan 2024 ➔ Sep 2024

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

Atara Biotherapeutics Announces Third Quarter 2024 Financial Results and Operational Progress (Businesswire) - "ATA3219: CD19 Program in Lupus Nephritis (LN) - Atara expects to initiate a Phase 1 study of ATA3219 as a monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN]) by end of year with initial clinical data anticipated in mid-2025. ATA3219: CD19 Program in Extrarenal Systemic Lupus Erythematosus (ERL) Without Lymphodepletion (LD) - Atara expanded the Phase 1 LN study of ATA3219 with an additional cohort in ERL without LD, and expects initiation by end of year with initial clinical data anticipated in mid-2025."

New P1 trial • P1 data • Lupus Nephritis • Systemic Lupus Erythematosus

Atara Biotherapeutics Announces Third Quarter 2024 Financial Results and Operational Progress (Businesswire) - "ATA3219: CD19 Program in Non-Hodgkin’s Lymphoma (NHL): First patient treated in ongoing Phase 1 clinical study of ATA3219 for NHL, including large B-cell lymphomas, follicular lymphoma, and mantle cell lymphoma; Study designed to evaluate safety, preliminary efficacy, pharmacokinetics, and biomarkers; Initial clinical data anticipated in Q1 2025; ATA3431: CD19/CD20 Program for B-Cell Malignancies: Atara is progressing toward an IND submission in Q4 2025."

IND • P1 data • Trial status • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma

ATA3219-AEC-104: A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants with Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Atara Biotherapeutics | N=26 ➔ 52

CAR T-Cell Therapy • Enrollment change • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Atara Biotherapeutics Announces Second Quarter 2024 Financial Results, Operational Progress and Leadership Update (Businesswire) - "ATA3219: CD19 Program in Lupus Nephritis (LN): Atara expects to initiate a Phase 1 study of ATA3219 as a monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN]) in Q4 2024 with initial clinical data anticipated in mid-2025....ATA3219: CD19 Program in Severe Systemic Lupus Erythematosus (SLE) Without Lymphodepletion: Atara plans to expand the Phase 1 LN study of ATA3219 and add a new cohort in severe SLE without lymphodepletion (LD) in Q4 2024 with initial clinical data anticipated in mid-2025."

New P1 trial • P1 data • Trial status • Lupus Nephritis • Systemic Lupus Erythematosus

Atara Biotherapeutics Announces Second Quarter 2024 Financial Results, Operational Progress and Leadership Update (Businesswire) - "ATA3219: CD19 Program in Non-Hodgkin’s Lymphoma (NHL) - Atara continues opening sites and initiating enrollment of a multi-center, Phase 1 open-label, dose-escalation clinical trial of ATA3219 in NHL, including large B-cell lymphomas, follicular lymphoma, and mantle cell lymphoma, with initial clinical data anticipated in Q1 2025....ATA3431: CD19/CD20 Program for B-Cell Malignancies:...Atara is progressing toward an IND submission in H2 2025."

IND • P1 data • Trial status • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma

Atara Biotherapeutics Presents Preclinical Data on ATA3219, an Allogeneic CD19-Targeted CAR T Therapy for the Treatment of B-Cell Driven Autoimmune Diseases, at the ISCT 2024 Annual Meeting (Businesswire) - "Atara Biotherapeutics...announced preclinical data supporting the potential of ATA3219, an allogeneic, anti-CD19 chimeric antigen receptor (CAR) T-cell therapy candidate for the treatment of B-cell driven autoimmune diseases. Findings demonstrate that ATA3219 maintains comparable cytotoxic function and potency while inducing lower levels of pro-inflammatory cytokines compared to autologous benchmark CD19 CAR T cells. The data will be presented in a poster session at the International Society for Cell & Gene Therapy (ISCT) 2024 Annual Meeting....Results Support Clinical Evaluation of ATA3219, Including Initiation of Phase 1 Study in Lupus Nephritis and Severe Systemic Lupus Erythematosus Without Lymphodepletion Expected in Q4 2024."

New P1 trial • Preclinical • Lupus Nephritis • Systemic Lupus Erythematosus

A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Lupus Nephritis (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: Atara Biotherapeutics

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

Atara Biotherapeutics Announces First Quarter 2024 Financial Results and Operational Progress (Businesswire) - "Atara initiated enrollment of a multi-center, Phase 1 open-label, dose-escalation clinical trial of ATA3219 in NHL, including large B-cell lymphomas, follicular lymphoma, and mantle cell lymphoma, with initial clinical data anticipated in Q4 2024...Total revenues were $27.4 million for the first quarter 2024, as compared to $1.2 million for the same period in 2023....due to revenue recognized as a result of additional obligations for the expanded partnership with Pierre Fabre and accelerated recognition of existing deferred revenue due to the planned transition of substantially all activities relating to tab-cel at the time of BLA approval and transfer to Pierre Fabre....anticipated payments of $20 million and $60 million from Pierre Fabre contingent upon the successful acceptance and approval of the tab-cel BLA..."

Commercial • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Immunology • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Kezar Life Sciences Reports First Quarter 2024 Financial Results and Provides Business Update (Businesswire) - "ATA3219: CD19 Program in Severe Systemic Lupus Erythematosus (SLE) Without Lymphodepletion: Atara plans to expand the Phase 1 LN study of ATA3219 and add a new cohort in severe SLE without lymphodepletion (LD) in Q4 2024 with initial clinical data anticipated in H2 2025."

P1 data • Trial status • Lupus Nephritis • Systemic Lupus Erythematosus

Atara Biotherapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Operational Progress (Businesswire) - "ATA3219: CD19 Program in Lupus Nephritis: Atara plans to initiate a Phase 1 LN study in H2 2024 with initial clinical data anticipated H1 2025....In vitro data demonstrated the CD19 antigen-specific functional activity of ATA3219 and CAR-mediated activity against B cells from SLE patients. ATA3219 led to near-complete CD19-specific B-cell depletion compared to controls. These preclinical data were submitted as part of a late-breaking abstract which was accepted for poster presentation at the upcoming International Society for Cell & Gene Therapy meeting held May 29-June 1, 2024."

New P1 trial • P1 data • Preclinical • Lupus Nephritis • Systemic Lupus Erythematosus

Atara Biotherapeutics Receives FDA Clearance of IND Application in Lupus Nephritis for ATA3219, an Allogeneic CAR T Therapy (Businesswire) - "Atara Biotherapeutics...announced the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for ATA3219, an allogeneic, anti-CD19 chimeric antigen receptor (CAR) T-cell monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN])....The multi-center, Phase 1, open-label, single-arm, dose-escalation study will evaluate the safety and preliminary efficacy of ATA3219 in subjects with LN....Each dose level is designed to enroll 3-6 patients, with the first subject expected to be enrolled in the second half of 2024....Initial Clinical Data...for Lupus Nephritis [anticipated] in H1 2025."

IND • New P1 trial • Lupus • Lupus Nephritis

Atara Biotherapeutics Receives FDA Clearance of IND Application in Lupus Nephritis for ATA3219, an Allogeneic CAR T Therapy (Businesswire) - "Initial Clinical Data in NHL Anticipated in H2 2024..."

P1 data • Non-Hodgkin’s Lymphoma

Atara Biotherapeutics Announces Submission of Investigational New Drug Application for ATA3219 for Treatment of Lupus Nephritis (Businesswire) - "Atara Biotherapeutics, Inc...announced its recent submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of ATA3219 as a monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN])."

IND • Immunology • Lupus Nephritis • Systemic Lupus Erythematosus

A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Atara Biotherapeutics

New P1 trial • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Indolent Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

Atara Biotherapeutics to Present Recent Progress and Key Upcoming Milestones at the 42nd Annual J.P. Morgan Healthcare Conference (Businesswire) - "Atara is progressing development of ATA3219, an allogeneic, off-the-shelf CAR T targeting CD19, optimized for a memory phenotype and incorporating a next generation 1XX signaling domain....Site selection and activation is ongoing for the Phase 1 study in relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL) and progressing toward enrolling the first patient in Q1 2024; Preliminary clinical data in lymphoma anticipated H2 2024."

New P1 trial • P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Atara Biotherapeutics Announces Expanded Global Tab-cel Partnership with Pierre Fabre Laboratories and Third Quarter 2023 Financial Results (Businesswire) - "...Initiation of Phase 1 study in relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL) for ATA3219—an allogeneic CD19-1XX CAR+ EBV T cell immunotherapy—expected in the coming months with preliminary clinical data anticipated H2 2024....Continued advancement of promising early AlloCAR-T development programs including ATA3431, an allogeneic, bispecific tandem CAR directed against both CD19 and CD20 built on the EBV T-cell platform with a 1XX costimulatory signaling domain. ATA3431 preclinical data has been accepted for poster presentation at the upcoming American Society of Hematology (ASH) meeting in December 2023."

P1 data • Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Atara Biotherapeutics Announces Second Quarter 2023 Financial Results and Operational Progress (Businesswire) - "A Phase 1 study in relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL) is expected to start in the coming months following Atara’s receipt of a Safe to Proceed letter from FDA in response to an Investigational New Drug Application (IND) submitted for ATA3219."

IND • New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Atara Biotherapeutics Announces First Quarter 2023 Financial Results and Operational Progress (Businesswire) - "Atara is advancing an Investigational New Drug Application (IND) for ATA3219, an allogeneic CD19-1XX CAR+ EBV T cell immunotherapy that incorporates multiple clinically validated technologies designed for T-cell memory, robust expansion, and potent anti-tumor efficacy, that is anticipated for filing in Q2 2023."

IND • Hematological Malignancies • Oncology

Optimization and Characterization of ATA3219: A Novel and Potent Allogeneic CD19-CAR T Therapy without Gene-Editing (TCT-ASTCT-CIBMTR 2023) - "This updated preclinical dataset for ATA3219 demonstrates the flexibility of our EBV T-cell manufacturing process through improvements in the polyfunctional phenotype, potent expansion and targeting against B cell tumors with low alloreactivity. These findings support advancing ATA3219 to clinical evaluation."

IO biomarker • Acute Lymphocytic Leukemia • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • CD19