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CAR T-cell Therapy

ATA3219 Dose Level 3 for B-Cell Lymphoma

Phase 1

Recruiting

Research Sponsored by Atara Biotherapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Histologically confirmed, R/R, B-cell NHL according to the 2022 revision of the World Health Organization classification of lymphoid neoplasms defined as LBCL, FL Grade 3b, or MCL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening (≤ 28 days before enrollment) through 24 months after last dose

Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of ATA3219 in patients with B-cell non-Hodgkin Lymphoma that has come back or not responded to previous treatments.

Who is the study for?

This trial is for people with B-cell non-Hodgkin Lymphoma that has come back or didn't respond to previous treatments. Specific details on eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions.Check my eligibility

What is being tested?

The study is testing ATA3219's safety and how well it works in treating various types of B-cell non-Hodgkin Lymphoma that have relapsed or are refractory (resistant to treatment).See study design

What are the potential side effects?

Specific side effects of ATA3219 aren't listed, but common ones for cancer treatments include fatigue, nausea, immune system reactions, and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition didn't improve after 2 treatments; if I had a cell transplant, my disease returned within a year.

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My lymphoma is confirmed as specific types according to WHO 2022.

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I had a good response to my previous CD19 therapy for LBCL and it lasted more than 3 months.

Select...

I can carry out all my usual activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening (≤ 28 days before enrollment) through 24 months after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening (≤ 28 days before enrollment) through 24 months after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (≤ 28 days before enrollment) through 24 months after last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinically Significant Changes in Laboratory Parameters

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

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

+3 more

Secondary outcome measures

Complete Response Rate (CRR)

Duration of Response (DOR)

Last Observed Plasma Concentration (Clast) of ATA3219

+9 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: ATA3219 Dose Level 4Experimental Treatment1 Intervention

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

Group II: ATA3219 Dose Level 3Experimental Treatment1 Intervention

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

Group III: ATA3219 Dose Level 2Experimental Treatment1 Intervention

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

Group IV: ATA3219 Dose Level 1Experimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Atara BiotherapeuticsLead Sponsor

12 Previous Clinical Trials

665 Total Patients Enrolled

Aditi Mehta, DOStudy DirectorAtara Biotherapeutics

2 Previous Clinical Trials

66 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which specific criteria determine the eligibility of individuals to participate in this research endeavor?

"Interested individuals must have b-cell lymphoma and be between 18 and 120 years old to meet the eligibility criteria for this trial, which aims to enroll a total of 40 participants."

Answered by AI

Are patients currently able to participate in this ongoing trial?

"According to the information provided on clinicaltrials.gov, this medical trial is presently in search of suitable participants. The original posting date for this trial was January 22nd, 2024, and it underwent its latest update on February 5th of the same year."

Answered by AI

Has the initial dosage level of ATA3219 been given the green light by the FDA?

"Given the preliminary nature of this Phase 1 trial, our evaluation ranks ATA3219 Dose Level 1 with a safety score of 1."

Answered by AI

What is the total number of individuals who are currently enrolled as participants in this medical study?

"Indeed, the details on clinicaltrials.gov affirm that this investigation is currently seeking volunteers. It was initially shared on January 22nd, 2024 and last revised on February 5th, 2024. The study aims to enlist 40 participants from a single site."

Answered by AI

Is there an age restriction regarding participants below 45 years old for this study?

"Individuals between the ages of 18 and 120 are eligible for participation in this research study. Notably, there is a total of 366 investigations catering to those under 18 years old and 1855 tailored for individuals over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06256484.

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