← Back to Search

CAR T-cell Therapy

Cellular Immunotherapy 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

Patients with minimal residual disease (MRD) defined as presence of malignant cells at 0.01% or more by flow cytometry or PCR analysis at completion of initial remission induction therapy

Patients with Karnofsky performance status (KPS) of >= 70%

Must not have

Patients receiving other investigational agents, concurrent biological, chemotherapy, or radiation therapy

Patients with any lymphoproliferative disorder

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 cancer therapy that uses modified genes to help the body build an immune response to kill cancer cells.

Who is the study for?

This trial is for patients with high-risk acute lymphoblastic leukemia who have had a relapse or still have disease after treatment. They must be in good physical condition, not need oxygen support, and have normal organ function. Pregnant women and those with active infections or other cancers are excluded.

What is being tested?

The trial tests cellular immunotherapy by modifying white blood cells to fight cancer. It aims to determine the best dose and side effects of this therapy using T-lymphocytes engineered to target leukemia cells.

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related responses, fatigue, fever, chills, shortness of breath, low blood pressure, nausea and potential damage to organs targeted by the modified T-cells.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a small amount of cancer cells left after my first treatment.

Select...

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

Select...

I agree to use effective birth control during and for six months after the study.

Select...

My white blood cell count is 10,000 or less before T cell ablation.

Select...

My T cells have been prepared for infusion.

Select...

My disease has come back or hasn't responded to treatment.

Select...

I have ALL that has come back or not fully gone away after treatment, and my cancer cells are CD19 positive.

Exclusion Criteria

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

Select...

I am not currently on any experimental treatments or undergoing chemotherapy or radiation.

Select...

I have a disorder that affects my lymph cells.

Select...

I do not have any uncontrolled illnesses or conditions that would limit my participation.

Select...

I do not have active hepatitis, HIV, or any signs of infection.

Select...

I do not have another active cancer, and 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

Complete response (CR) or CR with incomplete bone marrow recovery (CRi) with the exception of participants in CR or CRi that go from minimal residual disease (MRD) negative to MRD positive or progress as determined by the principal investigator

DLT rate at RP2D assessed using CTCAE version 4.0 for Arm II (CD19R(EQ)28zeta/EGFRt+ naive and memory T cells [TN/NEM])

Dose-limiting toxicity (DLT) rate at the phase II recommended dose (RP2D) (CD19R(EQ)28zeta/EGFRt+ central memory T cells)

+1 more

Secondary study objectives

Immunoglobulin G

Detection of transferred T cells in the circulation for at least 28 days by quantitative-polymerase chain reaction (PCR)

No MRD

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

Active Control

Group I: Arm I (cellular immunotherapy closed to accrual January 2019)Experimental Treatment2 Interventions

Patients receive lymphodepleting regimen per treating physician's discretion 3-14 days before the T-cell infusion. Patients receive CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells IV over 15 minutes on day 0. Patients who have evidence of disease, whose tumor(s) continue to express the appropriate antigen target may receive an optional second infusion of CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells after 28 days.

Group II: Arm II (cellular immunotherapy)Active Control2 Interventions

Patients receive lymphodepleting regimen per treating physician's discretion 3-14 days before the T-cell infusion. Patients receive CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/nem-enriched T cells IV over 15 minutes on day 0. Patients who have evidence of disease, whose tumor(s) continue to express the appropriate antigen target may receive an optional second infusion of CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/nem-enriched T cells after 28 days.

0 / 12Eligibility criteria met