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CAR T-cell Therapy

CAR T Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1

Recruiting

Led By Ibrahim Aldoss

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Histologically confirmed CD19+ relapsed/refractory ALL with at least 2 prior lines of therapy

Women of childbearing potential (WOCBP): negative urine or serum pregnancy test

Must not have

Clinically significant uncontrolled illness

Received prior CAR T therapy within 90 days of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new therapy called huCD19-CAR T cell therapy for treating patients with a type of leukemia called B-cell acute lymphoblastic leukemia (ALL) that has not responded to

Who is the study for?

This trial is for patients with CD19 positive B-cell acute lymphoblastic leukemia that has relapsed or is refractory. Participants must have adequate organ function and no active infections. They cannot join if they've had certain recent treatments, other cancers, central nervous system involvement by leukemia, or are pregnant.

What is being tested?

The trial tests huCD19-CAR T cell therapy where a patient's immune cells are modified to attack cancer cells, combined with chemotherapy drugs fludarabine and cyclophosphamide. It aims to see if this approach is safe and effective against relapsed/refractory ALL.

What are the potential side effects?

Potential side effects include reactions at the infusion site, flu-like symptoms, changes in blood pressure or heart rate, difficulty breathing, fever, fatigue, headache and may also affect normal blood-forming cells leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My leukemia has returned or didn't respond to treatment after two attempts.

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I am a woman who can have children and have a negative pregnancy test.

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I do not have seizures that are currently uncontrolled.

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My bilirubin levels are normal or slightly elevated, not due to liver cancer.

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My cancer has returned after treatment or hasn't responded to treatment.

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My liver is functioning well, with normal bilirubin and enzyme levels.

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I do not have any ongoing infections that aren't under control.

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I can have a central line placed for treatment if I don't already have one.

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I am 18 years old or older.

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I am mostly able to carry out my daily activities.

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I don't need medication to maintain my blood pressure, and I don't have uncontrolled heart issues.

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I don't need extra oxygen and my oxygen levels are above 92% without help.

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I do not need medication to maintain my blood pressure and I don't have irregular heartbeats that cause symptoms.

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I am mostly able to care for myself.

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I do not have any untreated or active infections.

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My heart condition does not severely limit my daily activities.

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I don't have a fever above 38.5°C and no recent infections.

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My blood has more than 1% CAR T cells.

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I don't need extra oxygen to maintain my oxygen levels and have no worsening lung issues on a recent chest x-ray.

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I don't need extra oxygen to maintain my oxygen levels and my chest x-ray shows no worsening issues.

Exclusion Criteria

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

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I do not have any uncontrolled serious illnesses.

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I received CAR T therapy less than 3 months ago.

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I have severe heart condition limitations.

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I am currently fighting an infection that needs antibiotics.

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I had a stem cell transplant from a donor within the last 100 days.

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I do not have uncontrolled seizures, recent strokes, severe brain injuries, dementia, cerebellar disease, or psychosis.

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I have a history of HIV or hepatitis B/C.

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I am not pregnant or breastfeeding.

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I am on medication for an autoimmune disease or for graft versus host disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years 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 limiting toxicity (DLT)

Secondary study objectives

Duration of response (DOR)

Extramedullary relapse

Minimal residual disease (MRD)

+6 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: Treatment (huCD19-CAR T)Experimental Treatment14 Interventions

Patients undergo leukapheresis then receive lymphodepletion chemotherapy with fludarabine IV and cyclophosphamide IV on days -5, -4 and -3 and huCD19-CAR T IV cells over 10-15 minutes on day 0. Patients may optionally receive cetuximab IV over 60-120 minutes at least 28 days post T cell infusion and undergo alloHCT. Additionally, patients undergo ECHO or MUGA, CT or PET/CT and optional MRI on study and bone marrow biopsy and aspiration and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Multigated Acquisition Scan

2015

Completed Phase 3

~270

Bone Marrow Aspiration

2011

Completed Phase 2

~1740