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CAR T-cell Therapy

CAR T-Cell Therapy and Vaccine for Acute Lymphoblastic Leukemia

Phase < 1

Waitlist Available

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

DONOR CRITERIA: KPS ≥ 70

Age: ≥ 18 years

Must not have

Any contraindications to standard conditioning transplant regimens per standard of care practices at COH

Participants with active autoimmune disease requiring systemic immune suppressive therapy are not allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with high-risk acute lymphoblastic leukemia. The treatment involves using modified immune cells called CAR T cells, which are designed to attack cancer cells. These CAR

Who is the study for?

This trial is for high-risk acute lymphoblastic leukemia patients who have undergone a stem cell transplant from a matched related donor. Participants must be eligible for all study procedures and interventions.

What is being tested?

The trial tests the safety and effectiveness of CMV-specific CD19-CAR T cells combined with a CMV-MVA vaccine in treating leukemia post-stem cell transplant. It involves modifying immune cells to target cancer, followed by vaccination to enhance the immune response.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, flu-like symptoms, changes in blood pressure or heart rate, fatigue, fever, chills, and risk of infection due to immune system modification.

Eligibility Criteria

Inclusion Criteria

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

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My donor is mostly able to care for themselves.

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

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My heart pumps well, with an ejection fraction of 45% or higher.

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

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My kidney function is within the required range and I am not on dialysis.

Exclusion Criteria

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

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I have no health issues that prevent me from undergoing standard transplant procedures.

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I am not on immune suppressive therapy for an autoimmune disease.

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I do not have any immune or inflammatory diseases affecting my brain or nerves.

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I do not have any uncontrolled illnesses that could affect my participation in the study.

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I have a bleeding disorder like von Willebrand's or hemophilia.

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I have seizures that are not controlled by medication.

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I have active viral hepatitis.

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I have an infection that isn't getting better with antibiotics.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 toxicities (DLT)

Incidence of adverse events (AEs)

Secondary study objectives

Acute graft versus host disease (GVHD)

Chronic GVHD

Cytomegalovirus reactivation requiring antiviral treatment

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 (allo CMV-specific CD19-CAR T cells, CMV-MVA vaccine)Experimental Treatment15 Interventions

Patients receive HSCT conditioning regimen followed by alloHSCT per standard of care. Starting 28-49 days after alloHSCT, patients receive allo CMV-specific CD19-CAR T cells IV over 10-15 minutes on day 0. Patients receive CMV-MVA triplex vaccine IM on day 28 in the absence of DLTs and may receive an additional CMV-MVA triplex vaccine IM on day 56 in the absence of DLTs during the second evaluation period. Patients undergo ECHO or MUGA, blood and optional CSF sample collection and bone marrow biopsy and aspiration throughout the study. Patient may also undergo chest x-ray and lumbar puncture as needed per PI discretion and PET/CT or CT as clinically indicated throughout the study. Additionally, patients with neurological abnormalities at baseline may undergo MRI of brain throughout the study.

Group II: Part 1 (allo CMV-specific CD19-CAR T cellsExperimental Treatment14 Interventions

Patients receive HSCT conditioning regimen followed by alloHSCT per standard of care. Starting 28-49 days after alloHSCT, patients receive allo CMV-specific CD19-CAR T cells IV over 10-15 minutes on day 0. Patients undergo ECHO or MUGA, blood and optional CSF sample collection and bone marrow biopsy and aspiration throughout the study. Patient may also undergo chest x-ray and lumbar puncture as needed per PI discretion and PET/CT or CT as clinically indicated throughout the study. Additionally, patients with neurological abnormalities at baseline may undergo MRI of brain throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1240

Biospecimen Collection

2004

Completed Phase 3

~2030