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CAR T-cell Therapy

CAR T Cell Therapy for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By Manali Kamdar, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Subjects must not have signs or symptoms of CNS disease or detectable evidence of CNS disease on MRI at screening

Histologically confirmed aggressive B-cell NHL including specific types defined by WHO 2008

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post infusion

Awards & highlights

Study Summary

This trial is testing a new cancer treatment for people with a certain type of lymphoma. The treatment involves using the patient's own immune cells, which are modified in the lab to better target and kill the cancer cells. The trial is designed to see if the treatment is safe and effective.

Who is the study for?

Adolescents and adults with relapsed/refractory B-cell Non-Hodgkin Lymphoma who have tried at least two therapies, including an anthracycline and anti-CD20 monoclonal antibody. Participants must be over 16 years old, in good physical condition (ECOG score of 0 or 1), with no active central nervous system disease, adequate organ function, not pregnant or breastfeeding, willing to use birth control, and able to give informed consent.Check my eligibility

What is being tested?

The trial is testing the safety and tolerability of a new therapy using CD19x22 CAR T cells for those with aggressive forms of B-cell Non-Hodgkin Lymphoma that haven't responded well to other treatments. The first phase will find the highest dose patients can tolerate without severe side effects; the second phase will assess how effective this treatment is.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to cell infusion, symptoms related to inflammation in various organs caused by the CAR T cells targeting healthy tissue along with cancerous ones (known as 'on-target off-tumor' effects), fatigue from treatment-related stress on the body's systems, blood disorders resulting from bone marrow suppression by CAR T cells.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any brain-related symptoms or signs of disease on my brain MRI.

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My lymphoma is a type of aggressive B-cell NHL as confirmed by tests.

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My condition worsened or didn't improve after two different treatments.

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I am capable of becoming pregnant and have a negative pregnancy test.

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I am fully active or able to carry out light work.

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My condition worsened after a stem cell transplant using my own cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post 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

Phase 1: Determine the Phase 1b Dose Level

Phase 1: Overall Tolerability of CD19x22 CAR T Therapy in CAR-naive Subjects as Assessed by Type, Frequency, and Severity of Adverse Events (AEs)

CD19 Antigens

+2 more

Secondary outcome measures

Evaluate Clinical Efficacy of CD19x22 CAR T

Percentage of Patients for Whom the Desired Dose of CAR T Cells was Successfully Produced

Percentage of Study Participants who Receive CD19x22 CAR T Cell Infusion without Infusion Reaction

Trial Design

1Treatment groups

Experimental Treatment

Group I: CD19x22 CAR T Cell InfusionExperimental Treatment1 Intervention

Lymphodepleting chemotherapy following by infusion of CD19x22 CAR T Cells

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,506 Total Patients Enrolled

Manali Kamdar, MDPrincipal InvestigatorUniversity of Colorado, Denver

2 Previous Clinical Trials

15 Total Patients Enrolled

Jonathan Gutman, MDPrincipal InvestigatorColorado Research Center

Media Library

CD19x22 CAR T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05098613 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: CD19x22 CAR T Cell Infusion

Non-Hodgkin's Lymphoma Clinical Trial 2023: CD19x22 CAR T Cells Highlights & Side Effects. Trial Name: NCT05098613 — Phase 1

CD19x22 CAR T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05098613 — Phase 1

Frequently Asked Questions

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

What is the risk profile of CD19x22 CAR T Cells for human use?

"Due to the lack of clinical evidence surrounding CD19x22 CAR T Cells, our team at Power has assigned them a rating of 1 on the safety scale. This is in line with Phase 1 trial requirements that imply little data exists around efficacy and safety."

Answered by AI

Are there any opportunities to join this research trial at the present time?

"The information found on clinicaltrials.gov declares that this particular medical trial, initially posted in December 2021 and last updated in September 2022, is not presently accepting participants. Despite that, a total of 1780 different studies are still recruiting patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients

2021. "Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05098613.