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CAR T-cell Therapy
CAR T-Cell Therapy for Non-Hodgkin's Lymphoma
Phase 1
Recruiting
Led By Jae Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial will evaluate a new therapy for relapsed/refractory B-cell lymphoma to see if it is safe and effective, and to determine the best dose to use.
Who is the study for?
Adults over 18 with certain types of B-cell lymphoma that haven't responded to or have returned after treatment, including chemotherapy. Participants must have adequate kidney, liver, and heart function, no active CNS disease or other cancers requiring therapy beyond observation or hormones (except skin cancer), and not be pregnant.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a new CAR T cell therapy called 19(T2)28z1xx TRAC for relapsed/refractory B-cell lymphoma. It aims to find the highest dose with minimal side effects by monitoring participants' responses.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, symptoms related to infusion such as fever or chills, fatigue, changes in blood counts leading to increased infection risk, organ inflammation, and possibly neurological events.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphomaExperimental Treatment1 Intervention
Participants have histologically confirmed DLBCL and large B cell lymphoma. Participants will be treated with escalating doses of modified T cells.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,859 Total Patients Enrolled
TakedaIndustry Sponsor
1,203 Previous Clinical Trials
4,177,995 Total Patients Enrolled
Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
14 Previous Clinical Trials
455 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition limits me to minimal physical activity.I have an active brain or spinal cord disease.My oxygen levels are 92% or higher without extra oxygen.I am 18 years old or older.My cancer did not respond well to chemotherapy or returned within a year after treatment.My heart's pumping ability is below normal.I have had CD19 therapy before, but my cancer still shows CD19.I do not have any untreated serious infections.I have a significant neurological condition like epilepsy or severe brain injury.I have HIV or active hepatitis B or C.I do not have any active cancer besides my current diagnosis, except for skin cancer.My diagnosis is a type of large B cell lymphoma.I had a stem cell transplant over 3 months ago, with no active GvHD and I'm not on immunosuppressives.I am not pregnant or breastfeeding and will use birth control during and for 1 year after the study.I have severe heart failure or had a recent heart attack or serious heart rhythm problem.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphoma
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.
What risks do people with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphoma face?
"Since this is a Phase 1 trial, with limited data supporting the safety and efficacy of Participants with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphoma, we gave it a score of 1."
Answered by AI
What is the cap on the number of participants in this trial?
"Affirmative, the clinicaltrials.gov data indicates that this study is actively seeking enrollees and was originally posted on February 23rd 2023 with a last edit date of February 24th 2023. The trial requires 30 participants to be recruited from one medical facility."
Answered by AI
Are there any vacant positions for patients within this trial?
"Affirmative. According to clinicaltrials.gov, the trial is actively recruiting participants with its initial posting on February 23rd 2023 and last update made 24 hours later. The single research site requires 30 enrollees for completion of this experiment."
Answered by AI
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