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CAR T-cell Therapy

Anti-CD19 CAR-T Cell Infusion for Non-Hodgkin's Lymphoma (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

PRODIGY Trial 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.Check my eligibility

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.See study design

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.

PRODIGY Trial 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.

PRODIGY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

PRODIGY Trial Design

1Treatment groups

Experimental Treatment

Group I: Anti-CD19 CAR-T Cell InfusionExperimental Treatment1 Intervention

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,778,895 Total Patients Enrolled

Sagar Patel, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

1 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

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

Are there currently ongoing patient enrollments for this clinical trial?

"According to the details provided on clinicaltrials.gov, this particular trial is not currently accepting new participants. Its initial posting date was January 15th, 2024 and it was last updated on January 17th, 2024. However, there are indeed a total of 839 other ongoing clinical trials actively seeking eligible individuals for participation at present."

Answered by AI

What is the level of safety associated with administering Anti-CD19 CAR-T cell infusion to individuals?

"Based on the categorization of this trial as Phase 1, which indicates limited data supporting both safety and efficacy, our team at Power rates the safety of Anti-CD19 CAR-T Cell Infusion as a 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies

2024. "Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06227026.