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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have a small amount of cancer cells left after my first treatment.
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I am mostly able to care for myself and carry out daily activities.
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I agree to use effective birth control during and for six months after the study.
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My white blood cell count is 10,000 or less before T cell ablation.
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My T cells have been prepared for infusion.
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My disease has come back or hasn't responded to treatment.
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I have ALL that has come back or not fully gone away after treatment, and my cancer cells are CD19 positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Immunoglobulin G
Detection of transferred T cells in the circulation for at least 28 days by quantitative-polymerase chain reaction (PCR)
No MRD
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.
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,389 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,082 Total Patients Enrolled
Ibrahim AldossPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
21 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently on any experimental treatments or undergoing chemotherapy or radiation.I have a disorder that affects my lymph cells.I do not have any uncontrolled illnesses or conditions that would limit my participation.I have a small amount of cancer cells left after my first treatment.I haven't had cancer in the last 5 years, except for skin cancer.I do not have active hepatitis, HIV, or any signs of infection.I am mostly able to care for myself and carry out daily activities.I agree to use effective birth control during and for six months after the study.I stopped taking immunosuppressant drugs at least 2 weeks ago.My heart pumps well, with an ejection fraction over 45%.My white blood cell count is 10,000 or less before T cell ablation.I do not have major brain issues, drug allergies, steroid dependence, or active autoimmune diseases needing strong immune system suppression.My T cells have been prepared for infusion.My heart, lungs, kidneys, and liver are healthy enough for T cell ablation.I am in my second or later remission from ALL with a history of CD19+.My disease has come back or hasn't responded to treatment.I have ALL that has come back or not fully gone away after treatment, and my cancer cells are CD19 positive.I do not have another active cancer, and I am not pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (cellular immunotherapy closed to accrual January 2019)
- Group 2: Arm II (cellular immunotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experimental research currently accepting participants?
"As per the clinicaltrials.gov website, this research study is not actively recruiting patients anymore; however when it was initially posted on September 24th 2014 and last updated November 22nd 2022. Fortunately, there are 1,495 other available trials that participants can sign up for right now."
Answered by AI
What kind of risk do CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes present for individuals who receive them?
"Due to the limited data surrounding its safety and efficacy, CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes was assigned a score of 1."
Answered by AI
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