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CAR T-cell Therapy
CAR T-Cell Therapy for Non-Hodgkin's Lymphoma
Phase 1 & 2
Recruiting
Research Sponsored by 2seventy bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of B-cell NHL according to WHO 2017 classification or WHO 2016 classification where applicable: DLBCL (germinal center B cell [GCB] or activated B cell [ABC] type or not otherwise specified [NOS]), HGBCL (with MYC and BCL2 and/or BCL6 rearrangements or NOS), PMBCL, FL 3b, DLBCL transformed from FL
At least 1 FDG-avid lesion per Lugano Classification criteria at time of enrollment
Must not have
Active autoimmune disease requiring systemic immunosuppressive and/or cytotoxic therapy within the past two years
Progression within 6 weeks of prior anti-CD19 CAR T cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new CAR T cell drug product with a gene edit for relapsed or refractory B cell non-Hodgkin's lymphoma.
Who is the study for?
This trial is for adults over 18 with B-cell Non-Hodgkin's Lymphoma who have tried at least two prior treatments, including an anti-CD20 antibody and chemotherapy. They must have a measurable lesion and be in relatively good health (ECOG ≤ 2). Not eligible if they've had certain autoimmune diseases, allogeneic bone marrow transplant, previous CAR T cell therapy or specific organ damage.
What is being tested?
The study tests bbT369, a dual targeting CAR T cell drug with gene editing on patients with relapsed/refractory B-cell NHL. It's to see how safe it is and how well it works. This early-phase trial will gradually increase doses to find the right balance between effectiveness and safety.
What are the potential side effects?
Potential side effects of bbT369 may include reactions related to the immune system attacking normal cells (autoimmune responses), symptoms from rapid destruction of cancer cells (cytokine release syndrome), neurological issues, as well as general infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of B-cell non-Hodgkin lymphoma.
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I have at least one active cancer lesion detectable by PET scan.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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My B cell NHL has not improved after a stem cell transplant or at least 2 treatments including anti-CD20 and anthracycline.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not taken strong medication for an autoimmune disease in the last 2 years.
Select...
My condition worsened within 6 weeks after receiving anti-CD19 CAR T cell therapy.
Select...
I have had a bone marrow transplant from a donor, but self-donated stem cell transplants are okay.
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I have or had a brain lymphoma or significant brain disease.
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I have never received anti-CD79a therapy.
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
1Treatment groups
Experimental Treatment
Group I: bbT369 Experimental ArmExperimental Treatment1 Intervention
Open label, single arm treatment with bbT369
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Who is running the clinical trial?
2seventy bioLead Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
Anna Truppel-Hartmann, MDStudy Director2seventy bio, Inc.
1 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: bbT369 Experimental Arm