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CAR T-cell Therapy

Cohort B (EGFRt/19- 28z/IL-12 CAR T cells, conditioning) for Chronic Lymphocytic Leukemia

Phase 1

Waitlist Available

Led By Francisco J Hernandez-ILizaliturri

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

"This trial is testing a new type of treatment called EGFRt/19-28z/IL-12 CAR T cells for patients with certain types of blood cancers that have not responded to previous treatment

Who is the study for?

This trial is for patients with certain blood cancers (like lymphoma or leukemia) that have a protein called CD19 and haven't improved after treatment or have come back. Participants need to be in good physical shape, with no major heart, lung, kidney, liver, or mental health issues.Check my eligibility

What is being tested?

The study tests genetically modified immune cells (EGFRt/19-28z/IL-12 CAR T cells) to see if they're safe and effective against these CD19+ blood cancers. It's an early-phase trial to find the right dose of these engineered T cells that are infused back into the patient.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, flu-like symptoms, fatigue, fever, chills, breathing difficulties, changes in blood pressure and heart rate. There may also be risks related to how the immune system reacts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of adverse events

Maximal tolerated dose (MTD) of EGFRt/19-28z/IL-12 chimeric antigen receptor T-cells

Secondary outcome measures

Event free survival

Incidence of CR/CRi + partial response (PR) (ORR)

Incidence of complete remission (CR)/complete remission with incomplete count recovery (CRi)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B (EGFRt/19- 28z/IL-12 CAR T cells, conditioning)Experimental Treatment12 Interventions

Patients undergo leukapheresis prior to treatment and receive lymphodepletion chemotherapy with cyclophosphamide IV over 2 hours and fludarabine IV over 30 minutes on days -5, -4, and -3. Patients then receive EGFRt/19- 28z/IL-12 CAR T cells IV over 5 to 30 minutes on day 0. Patients also undergo ECHO or MUGA during screening. Patients also undergo CT or PET as well as bone marrow biopsy and aspiration and blood sample collection throughout the trial. Additionally, patients undergo a tissue biopsy during screening and on the trial.

Group II: Cohort A (EGFRt/19- 28z/IL-12 CAR T cells)Experimental Treatment10 Interventions

Patients undergo leukapheresis prior to treatment. Patients receive EGFRt/19- 28z/IL-12 CAR T cells IV over 5 to 30 minutes on day 0. Patients also undergo ECHO or MUGA during screening. Patients also undergo CT or PET as well as bone marrow biopsy and aspiration and blood sample collection throughout the trial. Additionally, patients undergo a tissue biopsy during screening and on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Biospecimen Collection

2004

Completed Phase 2

~1730

Biopsy

2014

Completed Phase 4

~1090

Cyclophosphamide

1995

Completed Phase 3

~3770

Positron Emission Tomography

2008

Completed Phase 2

~2240

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Computed Tomography

2017

Completed Phase 2

~2720

Echocardiography

2013

Completed Phase 4

~11670

Leukapheresis

2016

Completed Phase 2

~690

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,822 Total Patients Enrolled

Francisco J Hernandez-ILizaliturriPrincipal InvestigatorRoswell Park Cancer Institute

Frequently Asked Questions

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

Is this clinical trial currently accepting new participants?

"As per clinicaltrials.gov, the current status of this trial is not open for recruitment. Originally registered on April 15th, 2024, with the latest update made on April 1st, 2024. While this particular study isn't enrolling participants currently, it's worth noting that there are a total of 3938 other ongoing trials actively seeking eligible candidates at present."

Answered by AI

To what extent does Cohort A (EGFRt/19- 28z/IL-12 CAR T cells) pose risks for individuals?

"The safety rating for Cohort A (EGFRt/19-28z/IL-12 CAR T cells) is rated at 1 by our team at Power due to the early Phase 1 trial nature, indicating a scarcity of data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies

2024. "Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06343376.