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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06256484




Registration number
NCT06256484
Ethics application status
Date submitted
5/02/2024
Date registered
13/02/2024

Titles & IDs
Public title
A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Scientific 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
Secondary ID [1] 0 0
ATA3219-NHL-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory B-cell Non-Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATA3219

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

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

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

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


Treatment: Drugs: ATA3219
ATA3219 is allogeneic anti-CD19 chimeric antigen receptor T-cell, administered intravenously on Day 1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Day 1 through 90 days after the last dose of study drug
Primary outcome [2] 0 0
Incidence and Severity of Adverse Events of Special Interest (AESIs)
Timepoint [2] 0 0
Day 1 through 90 days after the last dose of study drug
Primary outcome [3] 0 0
Number of Participants With Clinically Significant Changes in Laboratory Parameters
Timepoint [3] 0 0
Day 1 through 90 days after the last dose of study drug
Primary outcome [4] 0 0
Incidence of Dose-limiting Toxicities (DLTs)
Timepoint [4] 0 0
Day 1 through Day 28 of first dose
Primary outcome [5] 0 0
Maximum Tolerated dose (MTD)
Timepoint [5] 0 0
Day 1 through Day 28 of first dose
Primary outcome [6] 0 0
Recommended Phase 2 Dose (RP2D)
Timepoint [6] 0 0
Day 1 through Day 28 of first dose
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of ATA3219
Timepoint [1] 0 0
Pre-dose Day 1 through 24 months after last dose on a defined schedule
Secondary outcome [2] 0 0
Time to Reach Cmax of ATA3219
Timepoint [2] 0 0
Pre-dose Day 1 through 24 months after last dose on a defined schedule
Secondary outcome [3] 0 0
Partial Area Under the Curve (pAUC) of ATA3219
Timepoint [3] 0 0
Pre-dose Day 1 through 24 months after last dose on a defined schedule
Secondary outcome [4] 0 0
Last Observed Plasma Concentration (Clast) of ATA3219
Timepoint [4] 0 0
Pre-dose Day 1 through 24 months after last dose on a defined schedule
Secondary outcome [5] 0 0
Time of Clast of ATA3219
Timepoint [5] 0 0
Pre-dose Day 1 through 24 months after last dose on a defined schedule
Secondary outcome [6] 0 0
Terminal Half-life (T1/2) of ATA3219
Timepoint [6] 0 0
Pre-dose Day 1 through 24 months after last dose on a defined schedule
Secondary outcome [7] 0 0
Objective Response Rate (ORR)
Timepoint [7] 0 0
Screening (= 28 days before enrollment) through 24 months after last dose
Secondary outcome [8] 0 0
Complete Response Rate (CRR)
Timepoint [8] 0 0
Screening (= 28 days before enrollment) through 24 months after last dose
Secondary outcome [9] 0 0
Time-to-response (TTR)
Timepoint [9] 0 0
Screening (= 28 days before enrollment) through 24 months after last dose
Secondary outcome [10] 0 0
Duration of Response (DOR)
Timepoint [10] 0 0
Screening (= 28 days before enrollment) through 24 months after last dose
Secondary outcome [11] 0 0
Progression-free Survival (PFS)
Timepoint [11] 0 0
Screening (= 28 days before enrollment) through 24 months after last dose
Secondary outcome [12] 0 0
Overall Survival (OS)
Timepoint [12] 0 0
Screening (= 28 days before enrollment) through 24 months after last dose

Eligibility
Key inclusion criteria
* 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:

1. LBCL
2. FL Grade 3b
3. 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:

1. 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
2. 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.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* Life expectancy of = 8 weeks.
* For participants being considered for retreatment: had a DLT with prior ATA3219 dose.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2028
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atara Biotherapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aditi Mehta, DO
Address 0 0
Atara Biotherapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
650-278-8930
Fax 0 0
Email 0 0
clinicalstudies@atarabio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06256484