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CAR T-cell Therapy
CAR T-Cell Therapy for Non-Hodgkin's Lymphoma/Chronic Lymphocytic Leukemia
Phase 1
Waitlist Available
Led By Nirav Shah, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CLL or B-cell NHL including follicular lymphoma, marginal zone lymphoma (splenic, nodal, extranodal), mantle cell lymphoma, Burkitt lymphoma, and DLBCL with associated subtypes (high-grade or aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus (EBV) + diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation)
Patients must be aged ≥18 years to 80 years with relapsed or refractory B-cell non-Hodgkin Lymphoma or chronic lymphocytic leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days after infusion
Awards & highlights
Study Summary
This trial will evaluate the safety of CAR20.19.22 T-cells in patients with B-cell non-Hodgkin lymphoma (NHL) / chronic lymphocytic leukemia (CLL).
Who is the study for?
Adults aged 18-80 with relapsed or refractory B-cell malignancies like CLL or NHL, who have adequate organ function and no active CNS involvement. They must not be pregnant, agree to use double barrier contraception, and cannot participate in other clinical trials. Excluded are those with recent transplants, certain treatments within specific timeframes before the trial starts, uncontrolled autoimmune diseases requiring steroids, active infections (HIV/Hepatitis), or prior CAR T-cell therapy.Check my eligibility
What is being tested?
The safety of different doses of CAR20.19.22 T-cells is being tested on patients with various types of B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. This phase I study will determine the maximum tolerated dose for further research.See study design
What are the potential side effects?
Potential side effects may include immune system reactions leading to inflammation in different organs, infusion-related reactions similar to allergic responses when cells are administered, fatigue from treatment burden on the body's resources, possible blood disorders due to bone marrow impact by the therapy.
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 blood cancer.
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I am between 18 and 80 years old with a specific type of lymphoma or leukemia that has not responded to treatment.
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I am able to care for myself but may not be able to do active work.
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My kidney function is good, with proper creatinine levels and clearance.
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My liver tests are within normal limits.
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My heart and lungs are working well enough for the trial.
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My CLL has not responded to specific treatments and is still measurable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days after infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days after infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Non-hematologic Adverse Events after Infusion
Number of grade 3-4 cytokine release syndrome (CRS).
Number of grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS)
Trial Design
10Treatment groups
Experimental Treatment
Group I: Indolent B-cell NHL Dose Level 1: 5x10^6 cells/kg: CAR20.19.22Experimental Treatment1 Intervention
The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Group II: Indolent B-cell NHL Dose Level 0: 2.5x10^6 cells/kg: CAR20.19.22Experimental Treatment1 Intervention
The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Group III: Indolent B-cell NHL Dose Level -2: 0.75x10^6 cells/kg: CAR20.19.22Experimental Treatment1 Intervention
The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Group IV: Indolent B-cell NHL Dose Level -1: 1x10^6 cells/kg: CAR20.19.22Experimental Treatment1 Intervention
The investigators will start at a dose of 2.5x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Group V: Indolent B-cell NHL Dose Expansion: CAR20.19.22Experimental Treatment1 Intervention
The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6 cells/kg.
Group VI: Aggressive B-cell NHL Dose Level 2: 5x10^6 cells/kg: CAR20.19.22Experimental Treatment1 Intervention
The investigators will start at a dose of 1.0x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Group VII: Aggressive B-cell NHL Dose Level 1: 2.5x10^6 cells/kg: CAR20.19.22Experimental Treatment1 Intervention
The investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Group VIII: Aggressive B-cell NHL Dose Level 0: 1x10^6 cells/kg: CAR20.19.22Experimental Treatment1 Intervention
The investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Group IX: Aggressive B-cell NHL Dose Level -1: .75x10^6 cells/kg: CAR20.19.22Experimental Treatment1 Intervention
The investigators will start at a dose of 1x10^6 cells/kg and either escalate or de-escalate based on the presence of toxicities.
Group X: Aggressive B-cell NHL Dose Expansion: CAR20.19.22Experimental Treatment1 Intervention
The maximum tolerated dose intervention will be updated when it is determined. It will be one of four doses: 0.75x10^6 cells/kg, 1x10^6 cells/kg, 2.5x10^6 cells/kg or 5x10^6 cells/kg.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,535 Total Patients Enrolled
Miltenyi Biomedicine GmbHIndustry Sponsor
33 Previous Clinical Trials
1,575 Total Patients Enrolled
Nirav Shah, MDPrincipal InvestigatorMedical College of Wisconsin
4 Previous Clinical Trials
140 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the most hazardous amount of CAR20.19.22 cells that can be administered to patients?
"Our analysis yields a rating of 1 for the safety profile of Dose Expansion: The maximum tolerated dose of CAR20.19.22 cells; this is due to it being in its introductory testing phase, wherein there are not many studies that back up its efficacy or safe usage."
Answered by AI
Are there any vacancies available for potential participants of this research?
"Affirmative. According to records found on clinicaltrials.gov, this medical research project is currently enrolling individuals for participation. The study was first uploaded onto the database on June 30th 2022 and then amended most recently on July 1st 2022. At present, 36 volunteers are sought across one location."
Answered by AI
How many participants have been enrolled in this research endeavor?
"Affirmative. Clinicaltrials.gov records confirm that this medical analysis, which was initially posted on June 30th 2022 is currently enrolling participants. 36 patients are needed from a single research site for the study to be successful."
Answered by AI
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