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CAR T-cell Therapy

CAR-T Therapy for Leukemia

Phase 1 & 2

Waitlist Available

Led By Bachanova Veronika, MD

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

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

Must have

Adequate organ function: Renal: Calculated estimated glomerular filtration rate ≥50 mL/min/1.73 m2, Hepatic: ALT and AST < 3x upper limit of normal, bilirubin < 2x upper limit of normal, Cardiac: Left ventricular ejection fraction (LVEF) > 45%, Pulmonary: SpO2 > 92% on room air

Diagnosis of R/R CD19+ B-ALL after failure of standard of care therapies with CD19 expression on blasts confirmed by flow cytometry or immunohistochemistry

Must not have

Diagnosis of Burkitt lymphoma

Class II or greater New York Heart Association Functional Classification criteria or serious cardiac arrhythmias likely to increase the risk of cardiac complications of cytokine therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment using modified donor immune cells in adults with a type of leukemia that hasn't responded to other treatments. These special cells are trained to find and control cancer cells. This approach has changed the treatment paradigm for relapsed or refractory lymphoma by enabling immune cells to detect and eliminate cancer cells.

Who is the study for?

Adults with relapsed/refractory CD19+ B-ALL who've failed standard treatments can join this trial. They must have a certain level of organ function, not be on recent immunosuppressives or investigational drugs, and cannot be pregnant or breastfeeding. Those with active infections, severe heart conditions, allergies to specific manufacturing components, or available FDA-approved CAR T cell therapy are excluded.

What is being tested?

The trial is testing the safety and effectiveness of allogeneic CAR19 regulatory T cells (CAR19-tTreg) in adults with stubborn leukemia that hasn't responded to other treatments. It's a two-part study: first finding the right dose and then seeing how well it works more broadly.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever and fatigue, issues from infused cells like allergic reactions or infusion-related symptoms, and possible organ inflammation due to the treatment's targeted action.

Eligibility Criteria

Inclusion Criteria

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

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My leukemia (B-ALL) is resistant to standard treatments and tests positive for CD19.

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I am mostly able to care for myself and carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Burkitt lymphoma.

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I have heart problems that could make treatment risky.

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An FDA-approved CAR T cell therapy for CD19+ B-ALL is available to me.

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I am HIV positive and on anti-retroviral therapy.

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I am on medication to suppress my immune system due to an autoimmune disease.

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I have been diagnosed with leukemia in my brain or spinal cord.

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I have not had a heart attack or severe heart issues in the last 2 months.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Finding of CAR19-tTregs

Measure CAR19-tTregs efficacy

Secondary study objectives

Incidence of CR

Incidence of grade 3-4 cytokine release syndrome (CRS)

Incidence of immune cell associated neurotoxicity syndrome (ICANS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase I/IIExperimental Treatment3 Interventions

Determine the maximum tolerated dose (MTD) of CAR19-tTreg. It will be administered in a single dose after high dose lymphodepleting chemotherapy to promote adoptive transfer. First dose of 1.0 x 10 6 CAR19-tTreg/kg recipient body weight (dose level 1).The subsequent doses are 3.0, 10.0 and 30.0 x 10 6 CAR19- tTreg/kg. PHASE II Expand trial on maximum tolerated dose (MTD) of CAR19-tTreg from Phase I. It will be administered in a single dose after high dose lymphodepleting chemotherapy to promote adoptive transfer.The CAR19-tTreg/kg dose is to be determined.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310