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CAR T-cell Therapy

CAR-T Cells for Lymphoma

Phase 1 & 2
Recruiting
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
Measurable disease must be documented within four weeks of the time of consent defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions >10 mm in long and short axis OR bone marrow involvement that is biopsy proven for B-cell NHL (see separate criteria for CLL).
Adequate renal function, defined as creatinine clearance >60 ml/min AND serum Cr≤1.5 mg/dL.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the first 28 days after infusion
Awards & highlights

Study Summary

This trial will test a new immunotherapy treatment for people with B cell malignancies that have failed other treatments. The trial will evaluate the safety and efficacy of the new treatment and the feasibility of manufacturing it.

Who is the study for?
Adults aged 18-80 with various types of B-cell non-Hodgkin Lymphoma that have not responded to previous treatments. Participants must be in good general health, with a performance score indicating they can care for themselves and perform light work, and no active infections like HIV or Hepatitis B/C. They cannot have had certain recent cancer treatments or organ transplants, and women must not be pregnant.Check my eligibility
What is being tested?
The trial is testing CAR-20/19-T cells made using Interleukin-7 and Interleukin-15 in patients with relapsed or refractory B cell malignancies. It's an early-phase study assessing the safety, effectiveness, and feasibility of producing these cells over different time frames (8/12 days) including cryopreserved options.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever, fatigue, headache; risk of infection; possible damage to organs where B-cells are present like the liver or kidneys; neurological symptoms if the brain is affected; allergic reactions during infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured by scans or has affected my bone marrow.
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My kidney function is good, with creatinine clearance over 60 ml/min and serum Cr at or below 1.5 mg/dL.
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My liver tests are within normal limits or not concerning for my condition.
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I am between 18 and 80 years old with B-cell non-Hodgkin Lymphoma that has come back or didn't respond to treatment.
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I've had brain scans and spinal fluid tests showing no current brain involvement.
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My platelet count is above 50,000 without recent transfusions.
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My white blood cell count is healthy without recent strong medication.
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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 platelet count is above 50,000 without recent transfusions.
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I haven't received IV fluids in the last 24 hours.
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I am able to care for myself but may not be able to do active work.
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I am between 18 and 80 years old with B-cell non-Hodgkin Lymphoma that has come back or didn't respond to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first 28 days after infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the first 28 days after infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Adverse Events after CAR 20/19-T cell infusion

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase 2 - Efficacy of CAR-20/19-T cells in MCLExperimental Treatment1 Intervention
Single-stage Phase II design with three-month CR as the target endpoint.
Group II: 8/12 Flexible Manufacturing with Mandated CryopreservationExperimental Treatment1 Intervention
8/12 flexible manufacturing with mandated cryopreservation prior to infusion of LV20.19 CAR T-cells. The enrollment will cap at 24 subjects.
Group III: 8/12 Day Production of CAR-T for Relapsed/Refractory Primary or Secondary CNS LymphomaExperimental Treatment1 Intervention
Phase 1: Determine safety of 2.5x106 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with primary/secondary central nervous system (CNS) lymphoma. Phase 1b: Safety and efficacy will be evaluated in this study that will enroll 12 to 24 patients.
Group IV: 8/12 Day Production of CAR-T for NHLExperimental Treatment1 Intervention
Phase 1: Determine safety of 2.5x10^6 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with relapsed, refractory B-cell NHL. Patients will be enrolled in 3+3 fashion. Phase 1b: Six to nine patient expansion cohorts at eight or 12-day manufacturing. If six patients are enrolled in Phase 1 then only six additional patients will be added. If three patients are enrolled in Phase 1 then nine additional patients will be treated for a total of 12 in each group.
Group V: 8/12 Day Production of CAR-T for CLLExperimental Treatment1 Intervention
Phase 1: Determine safety of 2.5x10^6 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with CLL. Patients will be enrolled in 3+3 fashion. Phase 1b: The enrollment will cap at 24 subjects.
Group VI: 12-Day Production of Car-T Cells for NHLExperimental Treatment1 Intervention
Phase 1: Determine safety of 2.5x10^6 cells/kg IL-7/IL-15 expanded CAR-20/19-T cells in patients with relapsed, refractory B-cell NHL. Patients will be enrolled in 3+3 fashion. Phase 1b: Six to nine patient expansion cohorts at 12-day manufacturing. If six patients are enrolled in Phase 1 then only six additional patients will be added. If three patients are enrolled in Phase 1 then nine additional patients will be treated for a total of 12 in each group.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,411 Total Patients Enrolled
Nirav Shah, MDPrincipal Investigator - Medical College of Wisconsin
Froedtert & The Medical College of Wisconsin
4 Previous Clinical Trials
88 Total Patients Enrolled

Media Library

CAR-20/19-T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04186520 — Phase 1 & 2
Mantle Cell Lymphoma Research Study Groups: 8/12 Day Production of CAR-T for NHL, 8/12 Day Production of CAR-T for CLL, 8/12 Flexible Manufacturing with Mandated Cryopreservation, 8/12 Day Production of CAR-T for Relapsed/Refractory Primary or Secondary CNS Lymphoma, Phase 2 - Efficacy of CAR-20/19-T cells in MCL, 12-Day Production of Car-T Cells for NHL
Mantle Cell Lymphoma Clinical Trial 2023: CAR-20/19-T Cells Highlights & Side Effects. Trial Name: NCT04186520 — Phase 1 & 2
CAR-20/19-T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04186520 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open positions for participants in this experiment?

"From the information available on clinicaltrials.gov, it appears that this study is looking for participants. The trial was first announced on May 18th, 2020 and updated most recently on July 1st, 2022."

Answered by AI

Does this experimental treatment program have an age limit?

"According to the inclusion criteria, patients aged 18-80 are able to enroll in this trial. There are 609 clinical trials that cater to patients under 18 while 3983 serve those over 65."

Answered by AI

How can I get involved in this clinical trial?

"Patients with leukemia, lymphocytic, chronic, b-cell and between the ages of 18 to 80 can be accepted into this study. A total of 65 patients are needed for enrolment."

Answered by AI

What is the upper limit to how many people can join this experiment?

"Yes, the information on clinicaltrials.gov indicates that this clinical trial is presently looking for candidates. The clinical trial was initially posted on 5/18/2020 and was most recently edited on 7/1/2022. The clinical trial is admitting 65 patients across 1 sites"

Answered by AI
~31 spots leftby Dec 2025