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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 below

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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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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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My platelet count is above 50,000 without recent transfusions.

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe side effects from past treatments not caused by my disease.

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I have previously received CAR T-cell therapy from a donor.

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I do not agree to participate in long-term follow-up.

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I have not had CAR-T cell therapy targeting CD19 or CD20 in the last 100 days or have significant remaining CAR-T cells.

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I have not had a stem cell transplant in the last 100 days, do not have GVHD, and am not on immunosuppression.

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I have a serious autoimmune disease or need high doses of steroids to control it.

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I developed a severe form of lymphoma or leukemia after an organ transplant.

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I have an active HIV, Hepatitis B, or C infection.

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I haven't had chemotherapy other than for lymphodepletion in the last 14 days.

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I haven't had chemotherapy or high-dose steroids in the weeks before my CAR-T cell collection.

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My cancer has spread to my brain or spinal cord.

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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

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

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.

0 / 19Eligibility criteria met

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Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

630 Previous Clinical Trials

1,179,856 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

CAR-20/19-T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04186520 — Phase 1 & 2

$Non-Hodgkin's Lymphoma Research Study Groups: 8/12 Day Production of CAR-T for NHL, 8/12 Day Production of CAR-T for CLL, 8/12 Flexible Manufacturing with Mandated Cryopreservation, 12-Day Production of Car-T Cells for NHL, 8/12 Day Production of CAR-T for Relapsed/Refractory Primary or Secondary CNS Lymphoma, Phase 2 - Efficacy of CAR-20/19-T cells in MCL$