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CAR T-cell Therapy

Armored CAR T Cells for Blood Cancer

Phase 1

Waitlist Available

Led By Jae Park, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have CD19+ B cell malignancy with relapsed or refractory disease

Patients with DLBCL, Transformed B cell lymphoma, or High grade B cell lymphoma must have biopsy proven relapsed disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up occurring within 30 days from the last infusion

Awards & highlights

Study Summary

This trial is testing different doses of specially prepared cells to see if they are safe for patients with cancer that has progressed after standard therapy. If the patients meet all eligibility criteria, they can be enrolled a second time to receive treatment in a higher dose level cohort.

Who is the study for?

Adults with certain blood cancers like CLL, ALL, and others that have not responded to standard treatments can join. They must have a specific marker called CD19 on their cancer cells and meet health criteria such as proper kidney function, liver function, heart performance (LVEF ≥40%), and no severe active infections or autoimmune diseases.Check my eligibility

What is being tested?

This trial is testing different doses of 'armored' CAR T cells designed to target CD19+ cancer cells in patients whose disease has returned after treatment. The study aims to find the safest dose level for these modified T cells and see how they affect the patient's body and cancer.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, changes in blood counts, fatigue, fever, breathing difficulties, organ inflammation or dysfunction due to the engineered T cell activity against cancerous B cells.

Eligibility Criteria

Inclusion Criteria

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

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My cancer affects B cells, has returned or didn't respond to treatment, and tests positive for CD19.

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My lymphoma has returned after treatment, confirmed by a biopsy.

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My iNHL cancer did not respond or has returned after 2 treatments.

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My CLL has not responded to at least 2 prior treatments and needs more treatment.

Select...

My oxygen levels are 92% or higher on room air.

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My leukemia or lymphoma did not respond to my first chemotherapy.

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I have ALL and my treatment with a specific cancer drug has not worked.

Select...

I am 18 years old or older.

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My iNHL cancer did not respond or has returned after treatment with a biologic agent.

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My lymphoma did not respond or has returned after treatment.

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I have a type of B cell lymphoma and am not eligible for a transplant.

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My CLL has not responded or has returned after treatment with a biologic agent.

Select...

My leukemia or lymphoma has returned after undergoing chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ occurring within 30 days from the last infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~occurring within 30 days from the last infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and occurring within 30 days from the last 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

Maximum tolerated dose (MTD)

Trial Design

1Treatment groups

Experimental Treatment

Group I: EGFRt/19-28z/4-1BBL CAR T cellsExperimental Treatment1 Intervention

Following enrollment, patients will undergo leukapheresis of peripheral blood for further T cell enrichment, activation and genetic modification using a retroviral vector encoding a CD19targeted CAR, the co-stimulatory ligand 4-1BBL and the EGFRt safety system (EGFRt/19-28z/4-1BBL). These T cells will be expanded and after the appropriate number of cells is generated, the modified T cells may be infused fresh or frozen for later use according to standard operation procedures. Modified T cell infusions will be administered 2-7 days following completion of the treating investigator's choice of conditioning chemotherapy. Serial sampling of blood and bone marrow will be performed following treatment to assess toxicity, therapeutic effects, and survival of the genetically modified T cells.

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,583 Total Patients Enrolled

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyIndustry Sponsor

14 Previous Clinical Trials

1,688 Total Patients Enrolled

Juno Therapeutics, Inc.Industry Sponsor

7 Previous Clinical Trials

770 Total Patients Enrolled

Media Library

EGFRt/19-28z/4-1BBL CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03085173 — Phase 1

Chronic Lymphocytic Leukemia Research Study Groups: EGFRt/19-28z/4-1BBL CAR T cells

Chronic Lymphocytic Leukemia Clinical Trial 2023: EGFRt/19-28z/4-1BBL CAR T cells Highlights & Side Effects. Trial Name: NCT03085173 — Phase 1

EGFRt/19-28z/4-1BBL CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03085173 — Phase 1

Frequently Asked Questions

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

Is this study still open to participants?

"Unfortunately, this clinical trial is not presently accepting participants at this time. According to the information displayed on clinicaltrials.gov, it was initially posted in March 15th 2017 and last edited October 24th 2022. However, there are many other medical studies actively recruiting patients with 613 being available right now."

Answered by AI

What potential risks do EGFRt/19-28z/4-1BBL CAR T cells pose to patients?

"Despite limited efficacy and safety data, EGFRt/19-28z/4-1BBL CAR T cells were given a score of 1 by Power's team due to this being an early Phase 1 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of "Armored" CAR T Cells Targeting CD19 For Patients With Relapsed CD19+ Hematologic Malignancies

2017. "A Trial of "Armored" CAR T Cells Targeting CD19 For Patients With Relapsed CD19+ Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03085173.