A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

NCT06256484 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: ATA3219-NHL-103
• Study Type: interventional
• Target: 1
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of ATA3219 in participants with relapsed/refractory (R/R) B-cell non-Hodgkin Lymphoma (NHL).

Conditions

Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Keywords

B-cell non-Hodgkin Lymphoma; Anaplastic lymphoma kinase; Epstein-Barr virus (EBV); Mantle cell lymphoma (MCL); Follicular lymphoma (FL); Diffuse Large B-cell Lymphoma (DLBCL); Large B-cell lymphoma (LBCL)

Outcome Measures

Primary Outcomes (6)

• Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)

  Day 1 through 90 days after the last dose of study drug

• Incidence and Severity of Adverse Events of Special Interest (AESIs)

  Day 1 through 90 days after the last dose of study drug

• Number of Participants With Clinically Significant Changes in Laboratory Parameters

  Day 1 through 90 days after the last dose of study drug

• Incidence of Dose-limiting Toxicities (DLTs)

  Day 1 through Day 28 of first dose

• Maximum Tolerated dose (MTD)

  Day 1 through Day 28 of first dose

• Recommended Phase 2 Dose (RP2D)

  Day 1 through Day 28 of first dose

Secondary Outcomes (12)

• Maximum Observed Plasma Concentration (Cmax) of ATA3219

  Pre-dose Day 1 through 24 months after last dose on a defined schedule

• Time to Reach Cmax of ATA3219

  Pre-dose Day 1 through 24 months after last dose on a defined schedule

• Partial Area Under the Curve (pAUC) of ATA3219

  Pre-dose Day 1 through 24 months after last dose on a defined schedule

• Last Observed Plasma Concentration (Clast) of ATA3219

  Pre-dose Day 1 through 24 months after last dose on a defined schedule

• Time of Clast of ATA3219

  Pre-dose Day 1 through 24 months after last dose on a defined schedule

Study Arms (4)

ATA3219 Dose Level 1

EXPERIMENTAL

Participants will receive a single IV infusion of ATA3219 Dose Level 1 on Day 1.

Drug: ATA3219

ATA3219 Dose Level 2

EXPERIMENTAL

Participants will receive a single IV infusion of ATA3219 Dose Level 2 on Day 1.

Drug: ATA3219

ATA3219 Dose Level 3

EXPERIMENTAL

Participants will receive a single IV infusion of ATA3219 Dose Level 3 on Day 1.

Drug: ATA3219

ATA3219 Dose Level 4

EXPERIMENTAL

Participants will receive a single IV infusion of ATA3219 Dose Level 4 on Day 1.

Drug: ATA3219

Interventions

ATA3219 DRUG

ATA3219 is allogeneic anti-CD19 chimeric antigen receptor T-cell, administered intravenously on Day 1.

ATA3219 Dose Level 1; ATA3219 Dose Level 2; ATA3219 Dose Level 3; ATA3219 Dose Level 4

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed, R/R, B-cell NHL according to the 2022 revision of the World Health Organization classification of lymphoid neoplasms \[Alaggio 2022\] defined as any of the following:
• LBCL
• FL Grade 3b
• MCL
• The following criteria apply for details of prior treatment/therapy: R/R to at least 2 lines of therapy; if the most recent line of therapy was autologous hematologic cell transplant (HCT), relapse within 12 months of the transplant.
• Measurable disease by scan (diagnostic positron emission tomography-positive and/or computed tomography-measurable) as per Lugano Classification \[Cheson 2014\]. Magnetic resonance imaging may be used when computed tomography with contrast is contraindicated or when mandated by local practice.
• If sufficient archival material is not available from the latest relapse, a new tumor biopsy is required any time during screening, prior to conditioning chemotherapy.
• Participants who have received prior CD19-directed therapy as the prior line of therapy:
• must have achieved either a CR or partial response as a best response and maintained the response for ≥ 3 months after receiving CD19-directed treatment, and
• must still have CD19+ disease as determined by a local laboratory.
• Eastern Cooperative Oncology Group performance status ≤ 2
• Adequate organ function
• Written informed consent as per protocol.
• Participants are able to commit to the inpatient portion of the study, encompassing conditioning (if per the institution's standard practice), and frequent monitoring during Days 1-15, as well as remain within 1 hour travel time of the clinical site for 28 days after each infusion.

You may not qualify if:

• History of a human immunodeficiency virus infection or acute or chronic active hepatitis B or C infection.
• History or presence of clinically relevant central nervous system (CNS) pathology.
• Unresolved Grade 1-2 Immune effector cell-associated neurotoxicity syndrome (ICANS) or experienced Grade 3-4 ICANS from prior chimeric antigen receptor T-cell.
• Unresolved graft-versus-host disease (GvHD) or Grade 3-4 acute GvHD from any prior therapy or moderate to severe chronic GvHD from any prior therapy.
• History of any one of the following cardiovascular conditions: class III or IV heart failure as defined by the New York Heart Association \[The Criteria Committee of the New York Heart Association 1994\], cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically meaningful cardiac disease, within the past 6 months of study informed consent.
• History of malignancies, other than R/R NHL, unless the participant has been disease-free for ≥ 1 year (certain noninvasive malignancies are allowed).
• Active primary, CNS-only, or systemic plus CNS involvement by lymphoma, unless the CNS involvement has been effectively treated.
• Active autoimmune disorders or inflammatory conditions that require systemic immunosuppressive therapies, including therapeutic doses of steroids.
• Has received prior allogeneic HCT or prior solid organ transplant.
• Systemic bacterial, viral, fungal, or other infection that is untreated or unresponsive to appropriate treatment (or requires IV antibiotics at enrollment); participants must be afebrile for ≥ 48 hours. Prophylactic antibiotics, antivirals, and antifungals are permitted.
• Concurrent serious uncontrolled or unresolved medical condition, including any laboratory abnormality or psychiatric illness.
• The following therapies within defined periods prior to the conditioning regimen: therapeutic doses of corticosteroids (\> 0.5 mg/kg/day of prednisone or equivalent), lymphodepleting chemotherapeutic agents, live attenuated vaccines, prior systemic cancer therapy, investigational agents, including approved drugs being used off label, autologous HCT, donor lymphocyte infusions, radiation, alemtuzumab.
• Female who is breastfeeding or pregnant.
• Inability or unwillingness to comply with study procedures.
• Unwilling to use protocol specified contraceptive methods.

Sponsors & Collaborators

• Atara Biotherapeutics: lead

Study Sites (6)

AdventHealth Cancer Institute

Orlando, Florida, 32804, United States

Location

Norton Cancer Institute - Saint Matthews

Louisville, Kentucky, 40207, United States

Location

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, 19107, United States

Location

University of Virgina

Charlottesville, Virginia, 22908, United States

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Related Publications (2)

• Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.

  PMID: 25113753 BACKGROUND

• Alaggio R, Amador C, Anagnostopoulos I, Attygalle AD, Araujo IBO, Berti E, Bhagat G, Borges AM, Boyer D, Calaminici M, Chadburn A, Chan JKC, Cheuk W, Chng WJ, Choi JK, Chuang SS, Coupland SE, Czader M, Dave SS, de Jong D, Du MQ, Elenitoba-Johnson KS, Ferry J, Geyer J, Gratzinger D, Guitart J, Gujral S, Harris M, Harrison CJ, Hartmann S, Hochhaus A, Jansen PM, Karube K, Kempf W, Khoury J, Kimura H, Klapper W, Kovach AE, Kumar S, Lazar AJ, Lazzi S, Leoncini L, Leung N, Leventaki V, Li XQ, Lim MS, Liu WP, Louissaint A Jr, Marcogliese A, Medeiros LJ, Michal M, Miranda RN, Mitteldorf C, Montes-Moreno S, Morice W, Nardi V, Naresh KN, Natkunam Y, Ng SB, Oschlies I, Ott G, Parrens M, Pulitzer M, Rajkumar SV, Rawstron AC, Rech K, Rosenwald A, Said J, Sarkozy C, Sayed S, Saygin C, Schuh A, Sewell W, Siebert R, Sohani AR, Tooze R, Traverse-Glehen A, Vega F, Vergier B, Wechalekar AD, Wood B, Xerri L, Xiao W. The 5th edition of the World Health Organization Classification of Haematolymphoid Tumours: Lymphoid Neoplasms. Leukemia. 2022 Jul;36(7):1720-1748. doi: 10.1038/s41375-022-01620-2. Epub 2022 Jun 22.

  PMID: 35732829 RESULT

MeSH Terms

Conditions

Lymphoma, B-Cell; Epstein-Barr Virus Infections; Lymphoma, Mantle-Cell; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Aditi Mehta, DO

  Atara Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: September 6, 2024
• Primary Completion: March 3, 2025
• Study Completion: March 30, 2025
• Last Updated: March 11, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); AU (2)