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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through month 24
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Incidence of safety events including: adverse events (AEs), adverse events of special interest (AESIs), and dose limiting toxicities (DLTs)
Secondary outcome measures
Phase 1: Overall Response Rate (ORR) according to the Lugano 2014 response criteria as assessed by Investigator
Phase 1: Rates of disease-specific response criteria including complete response rate(CRR), partial response rate(PRR), stable disease rate(SDR), and progressive disease rate(PDR) according to the Lugano 2014 response criteria as assessed by Investigator
Phase 1: Time to complete response (TCR)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: bbT369 Experimental ArmExperimental Treatment1 Intervention
Open label, single arm treatment with bbT369
Find a Location
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are taking part in this research project?
"In line with the inclusion criteria, 50 participants are needed for this experiment to be carried out successfully. The sponsor, 2seventy bio, is responsible for running the trial from multiple stations such as Stanford Cancer Institute in California and Colorado Blood Cancer Institute in Denver."
Answered by AI
At how many venues is this experiment taking place?
"The Stanford Cancer Institute in California, the Colorado Blood Cancer Institute situated in Denver and Sarah Cannon located in Nashville are all part of this trial's operational sites. Additionally, 4 other healthcare facilities have been recruited to participate as well."
Answered by AI
Are participants being accepted into the trial currently?
"According to the clinicaltrials.gov portal, this research endeavour is currently in search of participants. The trial was established on January 24th 2022 and its contents were updated most recently on November 17th 2022."
Answered by AI
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