RecruitingPhase 1NCT04892277

CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies

Phase I Dose Escalation Trial of CD19 Directed Chimeric Antigen Receptor T Cell Therapy in the Treatment of Relapsed/Refractory B Cell Malignancies


Sponsor

Mayo Clinic

Enrollment

25 participants

Start Date

Oct 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. Some T cells are removed from the blood, and then laboratory, researchers will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat cancer. The new modified T cells are called the IC19/1563 treatment. IC19/1563 may help treat patients with relapsed/refractory B cell malignancies.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a personalized immune cell therapy (CAR-T cell therapy targeting a protein called CD19) for patients with relapsed or treatment-resistant B-cell blood cancers, including various types of lymphoma and chronic lymphocytic leukemia (CLL). Researchers want to know if this approach is safe and effective in a broader population than currently approved products. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory B-cell lymphoma (any type), CLL, or SLL that has not responded to or progressed after two or more prior treatments - You cannot receive or do not qualify for currently approved CAR-T products - You have measurable disease on imaging and adequate organ function - You are not pregnant and agree to use effective contraception **You may NOT be eligible if...** - You are currently able to receive a commercially approved CD19 CAR-T therapy - You have a history of seizures, autoimmune brain disease, or severe neurological conditions - You have had a heart attack, heart failure (Class III/IV), or cardiac stent/angioplasty within 6 months - You have active hepatitis B, hepatitis C, or HIV - You are on high-dose steroids or systemic immunosuppressants - You have another active cancer requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563

Given IV

DRUGBendamustine

Given IV

PROCEDUREBiospecimen Collection

Undergo collection of blood and tissue samples

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT

DRUGCyclophosphamide

Given IV

DRUGFludarabine

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo CT/PET


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT04892277


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