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CAR T-cell Therapy

CAR-T Cells for Lymphoma and Leukemia (PRODIGY Trial)

Phase 1

Recruiting

Led By Sagar Patel, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed relapsed or refractory CD-19+ malignancy, including: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)/Richter's syndrome. CD-19+ must be confirmed by immunohistochemistry or flow cytometry analysis

Subjects who have relapsed or refractory disease after failing at least 2 or more prior lines of therapy

Must not have

Subjects with active infection that requires systemic treatment

Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is a type of study that involves using a type of treatment called anti-CD19 CAR-T cells to treat certain types of cancer (NHL, CLL, and ALL) that have come

Who is the study for?

This trial is for people with certain blood cancers (like Non-Hodgkin's Lymphoma and Acute Lymphoblastic Leukemia) that have come back or didn't respond to treatment. Participants should have cancer cells with a marker called CD19. Specific eligibility details are not provided, but typically include health status and prior treatments.

What is being tested?

The study tests CAR-T cell therapy, where patients' immune cells are engineered to fight their CD19 positive cancer after a pre-treatment with fludarabine and cyclophosphamide. It's an early-phase trial assessing safety of the manufactured CAR-T cells using CellReGen technology.

What are the potential side effects?

CAR-T cell therapy can cause side effects like fever, difficulty breathing, feeling very tired, confusion, weakness in different parts of the body, fast heartbeat and low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is CD-19 positive and includes conditions like NHL, ALL, or CLL.

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My condition did not improve after 2 or more treatments.

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My liver function tests are within the normal range.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I am not pregnant, am post-menopausal, or have been surgically sterilized.

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My kidney function is within the required range.

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I do not have, nor am I suspected to have, an infection.

Exclusion Criteria

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

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I am currently being treated for an infection.

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I haven't had major surgery in the last 4 weeks or I've fully recovered from it.

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I do not have a history of significant brain-related health issues like epilepsy or Parkinson's.

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I do not have active infections like TB, hepatitis B, C, or HIV.

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I have an autoimmune disease and have taken immunosuppressive medication in the last 6 months.

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I have cancer that has spread to my brain.

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I am not taking any medications that are not allowed in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Production and infusion of CAR-T therapy in 5/6 patients who have undergone successful apheresis and no more than 3/6 patients with ≥ grade 3 non-hematological CAR-T related toxicities or events of special interest within 28 days of CAR-T administration.

Secondary study objectives

Disease free survival at 1 year post CAR-T administration based on 2014 Lugano Criteria (NHL patients) , IWCLL criteria (CLL patients) or EWALL recommendations (ALL patients).

Objective response rate (ORR) defined as the proportion of subjects achieving a confirmed PR or CR at Day 28 and Month 3.

Overall survival as defined as the time from CAR-T administration until 6 months and 12 months post CAR-T administration