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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
Adequate renal function, defined as creatinine clearance >60 ml/min AND serum Cr≤1.5 mg/dL.
Patients aged ≥18 years and ≤80 years with relapsed or refractory B-cell non-Hodgkin Lymphoma
Must not have
Presence of ≥grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless due to underlying disease
Prior allogeneic CAR T-cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the first 28 days after infusion
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
My kidney function is good, with creatinine clearance over 60 ml/min and serum Cr at or below 1.5 mg/dL.
Select...
I am between 18 and 80 years old with B-cell non-Hodgkin Lymphoma that has come back or didn't respond to treatment.
Select...
My platelet count is above 50,000 without recent transfusions.
Select...
I am able to care for myself but may not be able to do active work.
Select...
I haven't received IV fluids in the last 24 hours.
Select...
I am able to care for myself but may not be able to do active work.
Select...
I am between 18 and 80 years old with B-cell non-Hodgkin Lymphoma that has come back or didn't respond to treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe side effects from past treatments not caused by my disease.
Select...
I have previously received CAR T-cell therapy from a donor.
Select...
I do not agree to participate in long-term follow-up.
Select...
I have not had CAR-T cell therapy targeting CD19 or CD20 in the last 100 days or have significant remaining CAR-T cells.
Select...
I have not had a stem cell transplant in the last 100 days, do not have GVHD, and am not on immunosuppression.
Select...
I have a serious autoimmune disease or need high doses of steroids to control it.
Select...
I developed a severe form of lymphoma or leukemia after an organ transplant.
Select...
I have an active HIV, Hepatitis B, or C infection.
Select...
I haven't had chemotherapy other than for lymphodepletion in the last 14 days.
Select...
I haven't had chemotherapy or high-dose steroids in the weeks before my CAR-T cell collection.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I haven't taken oral chemotherapy or antibody treatments in the last 7 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within the first 28 days after infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first 28 days after infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Adverse Events after CAR 20/19-T cell infusion
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
631 Previous Clinical Trials
1,181,858 Total Patients Enrolled
Nirav Shah, MDPrincipal Investigator - Medical College of Wisconsin
Froedtert & The Medical College of Wisconsin
5 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by scans or has affected my bone marrow.I have severe side effects from past treatments not caused by my disease.My kidney function is good, with creatinine clearance over 60 ml/min and serum Cr at or below 1.5 mg/dL.My liver tests are within normal limits or not concerning for my condition.I have not been on dialysis for kidney failure in the last 3 months.My recent brain MRI and spinal tap show no signs of cancer in my brain or spinal fluid.I have previously received CAR T-cell therapy from a donor.I have no other cancers except for certain skin cancers or specific low-grade lymphomas.I am between 18 and 80 years old with B-cell non-Hodgkin Lymphoma that has come back or didn't respond to treatment.I do not agree to participate in long-term follow-up.I've had brain scans and spinal fluid tests showing no current brain involvement.I have not had CAR-T cell therapy targeting CD19 or CD20 in the last 100 days or have significant remaining CAR-T cells.I have not had a stem cell transplant in the last 100 days, do not have GVHD, and am not on immunosuppression.I have a serious autoimmune disease or need high doses of steroids to control it.I developed a severe form of lymphoma or leukemia after an organ transplant.My platelet count is above 50,000 without recent transfusions.You have a history of following your prescribed treatment plan.I have not received anti-CD20 antibody treatment in the last 4 weeks.My white blood cell count is healthy without recent strong medication.My liver is working well.I have an active HIV, Hepatitis B, or C infection.I am able to care for myself but may not be able to do active work.I haven't had chemotherapy other than for lymphodepletion in the last 14 days.My platelet count is above 50,000 without recent transfusions.I haven't had chemotherapy or high-dose steroids in the weeks before my CAR-T cell collection.I haven't received IV fluids in the last 24 hours.My cancer has spread to my brain or spinal cord.I am able to care for myself but may not be able to do active work.My white blood cell count is healthy without recent strong medication.You must have a certain number of CD3 cells in your blood.Requirements that all patients must meet to be eligible for the clinical trial.My kidneys are working well.I haven't taken oral chemotherapy or antibody treatments in the last 7 days.I haven't had anti-CD19 antibody treatment in the last 4 weeks.I am between 18 and 80 years old with B-cell non-Hodgkin Lymphoma that has come back or didn't respond to treatment.My heart and lungs are working well.You are likely to live for at least 12 more weeks.You are currently participating in another clinical trial for a different treatment or taking experimental medications.
Research Study Groups:
This trial has the following groups:- Group 1: 8/12 Day Production of CAR-T for NHL
- Group 2: 8/12 Day Production of CAR-T for CLL
- Group 3: 8/12 Flexible Manufacturing with Mandated Cryopreservation
- Group 4: 12-Day Production of Car-T Cells for NHL
- Group 5: 8/12 Day Production of CAR-T for Relapsed/Refractory Primary or Secondary CNS Lymphoma
- Group 6: Phase 2 - Efficacy of CAR-20/19-T cells in MCL
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.
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