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CAR T-cell Therapy
CAR T-Cell Therapy for Leukemia
Phase 1
Recruiting
Led By Aimee C. Talleur, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky or Lansky performance score ≥ 50
Any relapse after allogeneic hematopoietic cell transplantation (HCT)
Must not have
NA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after car t-cell infusion
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new CAR T-cell product to see if it is safe and effective in treating patients with relapsed and/or refractory CD19-positive leukemia who are ≤ 21 years old.
Who is the study for?
This trial is for young patients (≤ 21 years old) with relapsed or refractory CD19-positive leukemia who haven't responded to previous treatments and are not suitable for autologous CD19-CAR T-cell therapy. They should have a matched family member donor, good heart, kidney, liver function, no severe infections or significant arrhythmias, and must agree to birth control if sexually active.
What is being tested?
The study tests the safety and maximum tolerated dose of allogeneic memory T-cells expressing a CD19-specific CAR in children and young adults with leukemia. It aims to find out how well these cells work against leukemia without causing graft-versus-host disease.
What are the potential side effects?
Potential side effects include reactions related to immune response such as inflammation in various organs, risk of infection due to weakened immunity from treatment, symptoms from graft-versus-host disease like rash or digestive issues, and general discomforts like fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most activities but may need help.
Select...
My condition relapsed after a stem cell transplant from a donor.
Select...
I am not a candidate for a specific type of cell therapy.
Select...
My leukemia tests positive for CD19.
Select...
My condition has not improved despite treatment.
Select...
My condition has worsened after initial improvement.
Select...
My liver enzymes are within 5 times the normal limit.
Select...
I haven't taken high doses of steroids within the last week.
Select...
My lung function is at least half of what is expected, or my oxygen levels are good without extra oxygen.
Select...
I have never been diagnosed with HIV.
Select...
My leukemia has returned or is not responding to treatment and tests positive for CD19.
Select...
I have not had a stem cell transplant from the same donor as my CAR T-cell therapy.
Select...
I have received a stem cell transplant from the same donor as my CAR T-cell therapy.
Select...
My condition has worsened or returned for at least the second time.
Select...
I do not have leukemia in my brain causing symptoms.
Select...
I am 18 years old or older.
Select...
I do not have any severe, uncontrolled infections.
Select...
My heart pumps well enough, meeting the minimum required efficiency.
Select...
I have had a failed attempt at collecting my own stem cells.
Select...
My condition did not improve after receiving additional treatment.
Select...
I have a family member who is at least a half match for organ or tissue donation.
Select...
I have been approved as a donor according to the required health regulations.
Select...
My kidney function is within the required range for my age.
Select...
I am 21 years old or younger.
Select...
My condition worsened or didn't improve after CD19-CAR T-cell therapy.
Select...
I am ineligible for a stem cell transplant as part of my first relapse treatment.
Select...
I have had a failed attempt at making CAR T-cells from my own cells.
Select...
My cancer did not respond to at least 2 rounds of strong chemotherapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
Not applicable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks after car t-cell infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after car t-cell infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose of allogeneic, CD19-CAR.CD45RA-negative cells
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: Group BExperimental Treatment6 Interventions
Participants in group B have not received a prior stem cell transplant from their CAR T-cell donor.
Group II: Group AExperimental Treatment6 Interventions
Participants in group A have received a prior stem cell transplant from their CAR T-cell donor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leukapheresis
2016
Completed Phase 2
~710
CliniMACS
2005
Completed Phase 3
~770
Mesna
2003
Completed Phase 2
~1380
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,438 Total Patients Enrolled
Aimee C. Talleur, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
1 Previous Clinical Trials
24 Total Patients Enrolled
Stephen Gottschalk, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
5 Previous Clinical Trials
104 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can do most activities but may need help.My condition relapsed after a stem cell transplant from a donor.I am not a candidate for a specific type of cell therapy.I have CD19-positive leukemia and cannot receive CAR T-cell therapy.You have never had a strong allergic reaction to products containing murine protein (protein from mice).My leukemia tests positive for CD19.My condition has not improved despite treatment.My condition has worsened after initial improvement.My liver enzymes are within 5 times the normal limit.I haven't taken high doses of steroids within the last week.My lung function is at least half of what is expected, or my oxygen levels are good without extra oxygen.I have never been diagnosed with HIV.It has been over 3 months since my hematopoietic cell transplantation.My leukemia has returned or is not responding to treatment and tests positive for CD19.I have not had a stem cell transplant from the same donor as my CAR T-cell therapy.I have received a stem cell transplant from the same donor as my CAR T-cell therapy.My condition has worsened or returned for at least the second time.I haven't taken any medication in the last 14 days that could affect CAR T-cell therapy.I do not have leukemia in my brain causing symptoms.I am 18 years old or older.I am eligible to donate blood components for medical use.I do not have any severe, uncontrolled infections.I haven't had symptoms of GVHD in the last 2 months.My cancer was confirmed to be CD19 positive within the last 2 months.My heart pumps well enough, meeting the minimum required efficiency.I have had a failed attempt at collecting my own stem cells.I have recovered from my previous stem cell transplant.My condition did not improve after receiving additional treatment.I haven't had a donor lymphocyte infusion in the last 28 days.I have a family member who is at least a half match for organ or tissue donation.I have been approved as a donor according to the required health regulations.My kidney function is within the required range for my age.I have not had chemotherapy injected into my spine within the last week.I have recovered from severe side effects of my previous treatments.I am 21 years old or younger.My condition worsened or didn't improve after CD19-CAR T-cell therapy.I am ineligible for a stem cell transplant as part of my first relapse treatment.I have had a failed attempt at making CAR T-cells from my own cells.Not applicable.The study is only accepting certain types of patients.My cancer did not respond to at least 2 rounds of strong chemotherapy.If you are a woman of childbearing age, you must not be pregnant or breastfeeding at the time of the study. You will need to take a pregnancy test within 14 days prior to enrollment.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
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.
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