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CAR T-cell Therapy

CAR-T Therapy for Leukemia

Phase 1 & 2

Recruiting

Led By Matthew Foster, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Karnofsky score > 60% if ≥16 years old, or Lansky performance score of greater than 60% if <16 years old

Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception

Must not have

Subjects must not have tumor in a location where enlargement could cause airway obstruction

Subjects with relapsed fulminant CD19+ ALL that is rapidly progressing with circulating lymphoblasts that are rising in proportion to >50% of circulating white blood cells

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to fight cancer by combining two existing methods. Antibodies attach to cancer cells, and T cells kill them. The new treatment, ATLCAR.CD19, is an antibody attached to a T cell. It has shown promise, but causes side effects in some patients.

Who is the study for?

This trial is for people aged 3-70 with relapsed/refractory B cell ALL, who've had some prior treatment. They must have a certain level of health and organ function, agree to contraception methods if applicable, and not be pregnant or breastfeeding. Those with severe infections or other active cancers aren't eligible.

What is being tested?

The study tests autologous T cells modified with a CD19 antigen (iC9-CAR19 cells) to treat leukemia. It includes an 'off switch' to reduce side effects like cytokine release syndrome. The goal is to find the safest dose that works best against cancer.

What are the potential side effects?

Potential side effects include flu-like symptoms from mild cytokine release syndrome to more serious issues such as neurotoxicity, cardiac arrest, multi-system organ failure, or even death in severe cases.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly independent in my daily activities.

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I am a man who either had a vasectomy or will use contraception.

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I am between 3-17 years old and weigh at least 10 kg, or I am an adult aged 18-70.

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My T cells have been modified and meet specific quality standards.

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My cancer cells are CD19 positive.

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I am willing to use two forms of birth control or abstain from sex.

Exclusion Criteria

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

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My tumor is not located where it could block my airway if it grows.

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My aggressive leukemia is worsening with over half of my white blood cells being cancerous.

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I do not need extra oxygen to maintain my oxygen levels above 90%.

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I am currently taking 10 mg or more of prednisone daily or its equivalent.

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I am taking corticosteroids equivalent to or more than 10 mg/day of prednisone.

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I have had a condition where my lymphocytes multiply unusually.

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I do not have active HIV, hepatitis B, or hepatitis C.

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I have another cancer that is growing and needs treatment.

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I have not had certain cancer treatments in the last 2 weeks.

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I have not had salvage chemotherapy within the last week.

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I have a history of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Number of participants with adverse events as a measure of safety and tolerability of iC9-CAR19 T cells

Secondary study objectives

Changes in patient reported health-related quality of life in adult patients

Changes in patient reported physical functions in adult patients

Changes in persistence of iC9-CAR19 T cells in vivo

+8 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: iC9-CAR19 cellsExperimental Treatment4 Interventions

The 3+3 design in adult subjects and an independent study using 3+3 design in pediatric subjects. The starting dose of 5 x 10\^5 transduced cells/kg will enroll 3 adult subjects in the initial cohort. If there are no dose limiting toxicities w/in 4 weeks of the cell infusion in these 3 subjects, then the next cohort will evaluate 1 x10\^6 transduced cells/kg in adults. If there is toxicity in 1/3 patients in the initial cohort, the cohort will be expanded to enroll up to 6 adult patients. If the dose level 1 is determined to be above the tolerated cell dose, de-escalation would occur to dose level -1 where subjects would receive 1 x 10\^5 transduced cells/kg. All subjects will receive a lymphodepleting regimen of fludarabine and cyclophosphamide before administration of iC9-CAR19 T cells.

Group II: Expansion Cohort Second Administration of iC9-CAR19 cellsExperimental Treatment4 Interventions

After the recommended phase 2 dose (RP2D) of iC9-CAR19 T cells has been determined in adults, up to 18 additional adult subjects will be enrolled in an expansion cohort at the RP2D. In the expansion cohort, subjects will be offered a second infusion of iC9-CAR19 T cells based on B-cell recovery and minimal residual disease (MRD) status. All subjects will receive a lymphodepleting regimen of fludarabine and cyclophosphamide before second administration of iC9-CAR19 T cells. Subjects in the expansion cohort who experience ≥grade 2 CRS or ICANS, did not respond to the initial dose of the standard of care treatment will be enrolled in a sub-study of rimiducid.

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