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Relapsed/Refractory B-cell Non-Hodgkin LymphomaPhase 1NCT06256484

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

A Phase 1 study testing ATA3219 in people with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma, run by Atara Biotherapeutics at 6 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
ATA3219
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
6 sitesin 2 countries
Study dates
6 Sep 2024to 30 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • Life expectancy of ≤ 8 weeks.
  • For participants being considered for retreatment: had a DLT with prior ATA3219 dose.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States4 sites

  • University of Virgina

    Charlottesville, Virginia, 22908

  • Norton Cancer Institute - Saint Matthews

    Louisville, Kentucky, 40207

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia, Pennsylvania, 19107

Other trials in United States

Australia2 sites

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: A Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of ATA3219, Allogeneic Anti-CD19 Chimeric Antigen Receptor T-cell Therapy, in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

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).

Read the detailed description

This is a phase 1, open-labeled study to evaluate the safety and preliminary efficacy of ATA3219 (as monotherapy) in participants with NHL. During dose escalation, participants with R/R large B-cell lymphoma (LBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL) may be enrolled sequentially. Up to 4 dose levels will be explored in dose escalation. Prior to undergoing any screening procedure, prospective participants must undergo the ATA3219 inventory check assessments to ensure availability of an appropriate partially human leukocyte antigen-matched ATA3219 lot. Before administration of ATA3219, participants will receive conditioning chemotherapy within 7 days of enrollment. Participants will be hospitalized for at least 1 week to receive ATA3219, which will be administered by intravenous (IV) infusion on Day 1 in a staggered manner to allow appropriate safety monitoring. Four different dose levels will be studied in a sequential manner, and a lower dose level may be added, if needed. At least 3 and up to 6 dose-limiting toxicity (DLT)-evaluable participants, those who complete the 28-day DLT observation period, will be assessed at each dose level. Disease response will be assessed on Day 28 (+ 5 days) following each dose of ATA3219 by the investigator using the Lugano criteria (Cheson 2014). Participants who achieve complete response (CR) or progressive disease at Day 28 will enter the 24-month follow-up period. Participants who achieve partial response (PR), stable disease, or those who relapse within 12 months of the ATA3219 dose, may be considered for the second dose of ATA3219 per protocol. A third and final dose of ATA3219 may also be considered as per protocol.

After recommended phase 2 dose (RP2D) has been determined in the dose escalation stage, additional participants may be enrolled in 2 expansion cohorts (CD19-directed naive and prior CD19-directed therapy), opened at sponsor discretion and dosed at the proposed RP2D.

After treatment is completed or discontinued, participants will be followed for response and safety for up to 24 months from the last dose of ATA3219. After 2 years, a separate long-term follow-up study will be conducted to follow participants for up to a total of 15 years.

Being tested
ATA3219
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)
Medical subject headings
Lymphoma, B-Cell, Epstein-Barr Virus Infections, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATA3219Drug

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

Study groups in NCT06256484
Study groupRoleWhat they receive
ATA3219 Dose Level 1ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level 1 on Day 1.
Receives: Drug: ATA3219
ATA3219 Dose Level 2ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level 2 on Day 1.
Receives: Drug: ATA3219
ATA3219 Dose Level 3ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level 3 on Day 1.
Receives: Drug: ATA3219
ATA3219 Dose Level 4ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level 4 on Day 1.
Receives: Drug: ATA3219

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

  2. Incidence and Severity of Adverse Events of Special Interest (AESIs)

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

  3. Number of Participants With Clinically Significant Changes in Laboratory Parameters

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

  4. Incidence of Dose-limiting Toxicities (DLTs)

    Measured: Day 1 through Day 28 of first dose

  5. Maximum Tolerated dose (MTD)

    Measured: Day 1 through Day 28 of first dose

  6. Recommended Phase 2 Dose (RP2D)

    Measured: Day 1 through Day 28 of first dose

Secondary outcomes (12)

  1. Maximum Observed Plasma Concentration (Cmax) of ATA3219

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

  2. Time to Reach Cmax of ATA3219

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

  3. Partial Area Under the Curve (pAUC) of ATA3219

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

  4. Last Observed Plasma Concentration (Clast) of ATA3219

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

  5. Time of Clast of ATA3219

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

  6. Terminal Half-life (T1/2) of ATA3219

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

  7. Objective Response Rate (ORR)

    Measured: Screening (≤ 28 days before enrollment) through 24 months after last dose

  8. Complete Response Rate (CRR)

    Measured: Screening (≤ 28 days before enrollment) through 24 months after last dose

  9. Time-to-response (TTR)

    Measured: Screening (≤ 28 days before enrollment) through 24 months after last dose

  10. Duration of Response (DOR)

    Measured: Screening (≤ 28 days before enrollment) through 24 months after last dose

  11. Progression-free Survival (PFS)

    Measured: Screening (≤ 28 days before enrollment) through 24 months after last dose

  12. Overall Survival (OS)

    Measured: Screening (≤ 28 days before enrollment) through 24 months after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2024
  2. Study start6 Sep 2024
  3. Primary completion3 Mar 2025
  4. Study completion30 Mar 2025

Why it stopped: Financial reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06256484
Sponsor's protocol ID
ATA3219-NHL-103
Status last verified
Apr 2025
First submitted
5 Feb 2024
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25113753

  • 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.

    PubMed 35732829

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATA3219 in people with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma, run by Atara Biotherapeutics at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Financial reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 through 90 days after the last dose of study drug). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06256484, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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