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CAR T-cell Therapy
Gene-Modified T Cells for Acute Lymphoblastic Leukemia
Phase 1
Waitlist Available
Led By Jae Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed B-ALL and refractory patients are defined
Adult patients are eligible (> or = to 18 year old)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing an experimental treatment for leukemia that involves modifying immune cells called "T cells" to help them fight the cancer.
Who is the study for?
Adults over 18 with B-ALL leukemia that's resistant, relapsed, or in first complete remission can join. They need good heart and lung function, manageable blood chemistry levels, and a life expectancy over 3 months. Not allowed are those with recent heart attacks, severe heart failure, active GVHD from prior transplants, HIV/Hepatitis infections, active brain leukemia or other cancers needing treatment.Check my eligibility
What is being tested?
The trial tests T cells genetically modified to target CD19 on leukemia cells after being reinfused into the patient. The study aims to find the safe dose of these T cells post chemotherapy which is given to reduce leukemia and help T cells last longer.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to modified T-cells attacking normal tissues (autoimmunity), symptoms related to infusion like fever or chills, and typical chemotherapy-related issues such as nausea, fatigue or increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My B-ALL cancer has returned or is not responding to treatment.
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I am 18 years old or older.
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I have been diagnosed with B-ALL.
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My leukemia cells test positive for CD19.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in adult patients with B-ALL.
Secondary outcome measures
To assess the anti-leukemic effect of adoptively transferred anti-CD19 T cells.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pts with B Cell Acute Lymphoblastic LeukemiaExperimental Treatment1 Intervention
This is a phase I study. Patients with CD19+ ALL (CR, relapsed, MRD, or refractory) are eligible for enrollment. B-ALL patients in first CR will be enrolled but only treated if they develop MRD or a frank relapse, while patients with MRD or with documented relapsed/refractory disease are eligible for immediate treatment. The T cell doses originally proposed in this study were based on doses administered safely in prior autologous T cell adoptive therapy trials but the dose has been modified based on the toxicities observed in patients with morphologic evidence of disease. Patients will be treated with different doses of T cells depending on the amount of disease at the time of T cell infusion. Patients in Cohort 1 (<5% blasts in the BM) will continue to receive 10^6 19-28z+ T cells/kg as previously. Patients in Cohort 2 (≥5% blasts in the BM) will receive the reduced dose of 1x106 19-28z+ T cells/kg).
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,937 Previous Clinical Trials
588,227 Total Patients Enrolled
116 Trials studying Leukemia
9,249 Patients Enrolled for Leukemia
Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
14 Previous Clinical Trials
392 Total Patients Enrolled
10 Trials studying Leukemia
231 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My B-ALL cancer has returned or is not responding to treatment.My leukemia has spread to my brain or spinal cord recently.I had a stem cell transplant from a donor and am experiencing complications.I have HIV, hepatitis B, or hepatitis C.I have another active cancer besides the one being treated.I am 18 years old or older.My B-cell ALL is not responding to treatment, has returned, or is in the first complete remission.I need assistance with my daily activities.I have been diagnosed with B-ALL.My leukemia cells test positive for CD19.My kidney, liver, heart, and lung functions are within normal ranges and I am eligible for a specific blood filtering procedure.My blood cell counts are normal, indicating I am in complete remission.I have a heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Pts with B Cell Acute Lymphoblastic Leukemia
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.
What safety concerns should be taken into consideration when using gene-altered T cells for patient care?
"Due to scarce data regarding the safety and efficacy of gene-modified T cells, our team at Power rated their risk as a 1 on an ascending scale from 1-3."
Answered by AI
Are additional volunteers being accepted into the trial at this time?
"According to clinicaltrials.gov, the advertised trial is not actively seeking participants at this time. It was first posted on May 1st 2010 and last updated February 1st 2022--however, there are currently 1498 other medical studies that are soliciting enrolments."
Answered by AI
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