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CAR T-cell Therapy
Metabolically Fit CD19 CAR T-Cell Therapy for Non-Hodgkin's Lymphoma and Chronic B-Cell Leukemia
Phase 1 & 2
Recruiting
Led By Brian Hess, PHD
Research Sponsored by Medical University of South Carolina
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 duration of study, up to 24 months
Awards & highlights
Study Summary
This trial tests a new CAR T-cell therapy for adult patients with NHL or CLL/SLL that has relapsed or resisted treatment.
Who is the study for?
Adults with certain types of B-cell lymphomas or leukemia who've had at least two prior treatments can join this trial. They must be over 18, in fair health (ECOG 0-2), and have someone to help care for them after treatment. People with active brain lymphoma, recent heart issues, uncontrolled infections, or those who are pregnant/breastfeeding cannot participate.Check my eligibility
What is being tested?
The study is testing a new CAR T-cell therapy that targets CD19 on cancer cells. It's given after chemotherapy drugs Cyclophosphamide and Fludarabine to prepare the body. The trial will start with lower doses of the CAR T-cells and increase them to find the best dose without severe side effects.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion such as fever and chills, low blood cell counts leading to increased infection risk or bleeding, fatigue, breathing difficulties, organ inflammation like liver or kidneys, and neurological symptoms like confusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of study, up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study, up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CRS occurrence evaluation
ICANS occurrence evaluation
MTD/MAD/RP2D evaluation
Secondary outcome measures
ORR and CR evaluation at the RP2D
Overall response and complete remission rate
PFS, DOR and OS evaluation at the RP2D
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Dose Level 3Experimental Treatment3 Interventions
2 x 10^6 transduced T cells/kg (± 20%)
Group II: Dose Level 2Experimental Treatment3 Interventions
1.5 x 10^6 transduced T cells/kg (± 20%)
Group III: Dose Level 1Experimental Treatment3 Interventions
1 x 10^6 transduced T cells/kg (± 20%)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine Injection
2016
N/A
~30
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,609 Total Patients Enrolled
Brian Hess, PHDPrincipal InvestigatorMedical University of South Carolina
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have hepatitis B, C, or HIV and meet the specific health criteria.I have an autoimmune disease and haven't taken immunosuppressants in the last year.My lymphoma is confirmed to be CD19 positive.I am able to get out of my bed or chair and move around.I am 18 years old or older.I have not had a stroke or brain bleed in the last 6 months.I have active cancer in my brain or spinal cord.I have someone to take care of me during my CAR T-cell therapy.I have symptoms of Graft vs Host Disease from a stem cell transplant.I do not have any uncontrolled infections.I have had cancer other than lymphoma in the past year.My heart, liver, kidneys, lungs, and bone marrow are working well.I have not received a live vaccine in the last 28 days.I have had a stem cell transplant or CAR T-cell therapy recently.My treatment history matches the requirements for my type of lymphoma.I am not pregnant or breastfeeding.I've had CD19 therapy and a biopsy showing CD19 in my tissue.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1
- Group 2: Dose Level 3
- Group 3: Dose Level 2
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.
Are any participants being enrolled for this investigation currently?
"As detailed on clinicaltrials.gov, this medical study has not been actively enrolling patients since January 18th 2023. First posted in February 1st 2023, the trial is no longer recruiting; however, there are 2,857 other trials that still require volunteers to participate."
Answered by AI
What is the objective of this experiment?
"The primary outcome of this 12-month clinical trial will be CRS occurrence evaluation. Secondary outcomes include Progression free survival, duration of response and overall survival based on Anti-tumor activity at the RP2D with ORR and CR rate evaluations utilizing IWG 2014 Lugano criteria (for NHL) or iwCLL 2018 criteria (for CLL/SLL)."
Answered by AI
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