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CAR T-cell Therapy
BAFF CAR-T for Non-Hodgkin Lymphoma
Phase 1
Recruiting
Led By Paolo F. Caimi, MD
Research Sponsored by Luminary Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air
Cardiac ejection fraction of >50%, and no evidence of pericardial effusion, as determined by an echocardiogram
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trialwill explore if BAFF CAR-T cells can be used to treat lymphoma that didn't respond to traditional CAR-T cell therapy.
Who is the study for?
Adults over 18 with non-Hodgkin lymphoma that's come back after at least two treatments or hasn't responded to chemo can join. They need good liver, kidney, heart, and lung function, no brain lymphoma, and must use effective birth control. Those who've had recent other cancer treatments or have certain health issues like severe heart problems or active infections can't participate.Check my eligibility
What is being tested?
The trial is testing a new therapy called BAFF CAR-T cells for people whose non-Hodgkin lymphoma didn't respond to previous treatments including CD19 targeted CAR-T cells. It aims to find the safest dose of BAFF CAR-T and see how well it works against the disease.See study design
What are the potential side effects?
Potential side effects may include immune system reactions affecting different parts of the body, symptoms related to infusion such as fever or chills, tiredness, changes in blood counts leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My oxygen level is 92% or higher without extra oxygen.
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My heart pumps well and I don't have fluid around it.
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My non-Hodgkin lymphoma has returned after 2+ treatments or is resistant to chemotherapy.
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I can take care of myself but might not be able to do heavy physical work.
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I do not have lymphoma in my brain or spinal cord.
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I agree to either not have sex or use birth control, and not donate sperm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine recommended phase II dose of human LMY-920.
Secondary outcome measures
To determine incidence of adverse events.
To determine incidence of anti- LMY-920 antibodies.
To determine the complete response rate.
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: LMY-920 dose escalationExperimental Treatment1 Intervention
Open label, dose escalation study with up to four dose levels of LMY-920. The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design.
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Who is running the clinical trial?
Luminary TherapeuticsLead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
Case Comprehensive Cancer CenterOTHER
452 Previous Clinical Trials
31,890 Total Patients Enrolled
Paolo F. Caimi, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My oxygen level is 92% or higher without extra oxygen.I have had a stem cell transplant from a donor.My heart pumps well and I don't have fluid around it.I have an active cancer other than non-dangerous skin cancer or early-stage cancers.I have the most severe form of heart failure.I have an autoimmune disease and have taken strong immune-suppressing drugs in the last 6 months.My non-Hodgkin lymphoma has returned after 2+ treatments or is resistant to chemotherapy.I can take care of myself but might not be able to do heavy physical work.I am older than 18 years.I have had a stem cell transplant within the last 6 weeks.I am experiencing symptoms of graft-versus-host disease.My lymphoma or leukemia has spread to my brain or spinal cord.I am HIV positive.I do not have lymphoma in my brain or spinal cord.I agree to either not have sex or use birth control, and not donate sperm.I am currently receiving IV treatment for an infection.I do not have a history of significant brain-related health issues like epilepsy or severe brain injuries.I have another cancer that needs treatment through the bloodstream.My tests show early signs of a bone marrow disorder before starting treatment.I can understand and am willing to sign the consent form.It has been over 2 weeks since my last radiation or systemic therapy.I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: LMY-920 dose escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration conferred approval for escalating doses of LMY-920?
"Due to the minimal amount of data available on its efficacy and safety, LMY-920 dose escalation received a score of 1."
Answered by AI
Are new participants still being accepted for this research endeavor?
"This clinical experiment, initially posted on January 23rd 2023 and recently updated on the 11th of that same month according to clinicaltrials.gov is actively recruiting participants."
Answered by AI
How many participants are being evaluated in this research endeavor?
"Affirmative. Clinicaltrials.gov provides the evidence that this medical investigation, which was originally publicised on January 23rd 2023, is still actively seeking participants. A total of 20 patients are being recruited from 2 distinct sites."
Answered by AI
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