Your session is about to expire
← Back to Search
CAR T-cell Therapy
CAR T-Cell Therapy for Lymphoma and Leukemia
Phase 2
Recruiting
Led By John Lister, MD
Research Sponsored by John Lister
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with CD19+ B-cell lymphoma or B-Cell Acute Lymphoblastic Leukemia (B-ALL) with no currently available curative treatment option and a limited prognosis (<2-year projected survival)
Subjects must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study Summary
This trial is testing a new way to generate cancer-fighting cells and safely administer them to patients with B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia.
Who is the study for?
Adults aged 18-79 with certain types of B-cell lymphoma or acute lymphoblastic leukemia that lack curative treatment options and have a life expectancy under two years. They must not be eligible for commercial CAR T-cell therapy, have measurable disease, and be able to understand the trial. Pregnant women, those unable to consent, or patients with active central nervous system cancer are excluded.Check my eligibility
What is being tested?
The trial is testing locally manufactured CAR T-cells in treating various forms of B-cell lymphoma and acute lymphoblastic leukemia. It aims to show this method can safely create and administer these cells to help manage these cancers when other treatments aren't available.See study design
What are the potential side effects?
Potential side effects may include immune reactions leading to symptoms like fever and fatigue (cytokine release syndrome), neurological events such as confusion or seizures, blood cell count changes increasing infection risk, allergic reactions during infusion, and organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have B-cell cancer with no cure and am expected to live less than 2 years.
Select...
I understand the risks and can consent to join the trial on my own.
Select...
I am between 18 and 79 years old.
Select...
My cancer cells have shown CD19 presence at some point.
Select...
I have a specific type of lymphoma or leukemia and previous treatments haven't worked.
Select...
I cannot receive the standard CD19-CAR T-cell therapy.
Select...
I don't need extra oxygen and I don't have trouble breathing when resting.
Select...
I am able to care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of administration
Successful local CAR T-cell manufacturing
Secondary outcome measures
CAR T-cell kinetics
Response to therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
CAR -T-cell collection, infusion
Find a Location
Who is running the clinical trial?
John ListerLead Sponsor
Lentigen Technology, Inc.UNKNOWN
AHN (Allegheny Health Network) Cancer InstituteUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an active hepatitis B infection.I have leukemia or lymphoma in my brain that hasn't been treated.Your CD3 count in your blood is higher than 200/µL.I haven't had cancer treatment within 4 weeks before my leukapheresis.I have B-cell cancer with no cure and am expected to live less than 2 years.I relapsed more than 100 days after my stem cell transplant.I am currently being treated for another type of cancer.I understand the risks and can consent to join the trial on my own.I am not pregnant and will use birth control.Your heart's pumping ability is normal, with an ejection fraction of at least 45%.I am a male and will use birth control during and for 6 months after the study.I have not taken high-dose steroids within the last 4 weeks.I haven't had checkpoint inhibitor therapy in the last 4 weeks.I am between 18 and 79 years old.My cancer cells have shown CD19 presence at some point.My B-ALL shows signs of disease at two different times, 2 weeks apart.I have treated transformed indolent lymphoma with at least one therapy cycle.I have hepatitis C with ongoing viral replication.I currently have an active infection.I have had a heart attack in the last 6 months or have heart issues that are not under control.I have a specific type of lymphoma or leukemia and previous treatments haven't worked.I received targeted radiation therapy within the last 14 days.Your blood, liver, or kidney tests show a significant health problem.My lymphoma can be measured or assessed.I have HIV with active viral replication.I cannot stop my immunosuppressive therapy for 4 weeks before leukapheresis.I cannot receive the standard CD19-CAR T-cell therapy.I don't need extra oxygen and I don't have trouble breathing when resting.I am able to care for myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
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.
Could I potentially take part in this research?
"The inclusion criteria for this trial requires that patients have large b-cell diffuse lymphoma and be between 18 and 79 years old. A total of 30 patients will be accepted into the study."
Answered by AI
Are we currently accepting participants for this research project?
"Yes, this clinical trial is still searching for eligible individuals to participate. The original posting was on April 19th, 2020 and the listing was updated as recently as August 10th, 2020."
Answered by AI
Does this study involve elderly patients?
"The age limit for this study is 79 years old, and all participants must be of legal adult age (18+)."
Answered by AI
To what extent does Chimeric Antigen Receptor (CAR) T-Cell Product (Autologous) pose a threat to human health?
"While there is some evidence that suggests this Chimeric Antigen Receptor (CAR) T-Cell Product (Autologous) is safe, as it is only in Phase 2 clinical trials, there is no data yet supporting its efficacy."
Answered by AI
Could you tell me how many individuals are included in this research project?
"Yes, the website clinicaltrials.gov has updated information that this study is still open for recruitment. The trial was first posted on April 19th, 2020 and was most recently updated on August 10th, 2020. They are looking for 30 more participants from 1 location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger