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CAR T-cell Therapy
ATA3219 for Non-Hodgkin's 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
Must not have
Female who is breastfeeding or pregnant
Active autoimmune disorders or inflammatory conditions that require systemic immunosuppressive therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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).
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 belowSelect...
My condition didn't improve after 2 treatments; if I had a cell transplant, my disease returned within a year.
Select...
My lymphoma is confirmed as specific types according to WHO 2022.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently pregnant or breastfeeding.
Select...
I am on medication for an autoimmune disorder or inflammation.
Select...
I have a history of HIV or hepatitis B or C.
Select...
I have had CD19-directed therapy for my MCL or FL.
Select...
I have severe complications from a previous transplant.
Select...
I have had a previous transplant of bone marrow or an organ.
Select...
I have an infection that isn't getting better with treatment.
Select...
I do not have any serious uncontrolled health issues.
Select...
I have a significant brain or spinal cord condition.
Select...
I have mild to moderate side effects from previous CAR T-cell therapy.
Select...
My lymphoma in the brain is either active or has been effectively treated.
Select...
I am unwilling to follow the study's birth control requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Who is running the clinical trial?
Atara BiotherapeuticsLead Sponsor
13 Previous Clinical Trials
701 Total Patients Enrolled
Aditi Mehta, DOStudy DirectorAtara Biotherapeutics
3 Previous Clinical Trials
78 Total Patients Enrolled