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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after car t-cell infusion
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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I can do most activities but may need help.
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My condition relapsed after a stem cell transplant from a donor.
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I am not a candidate for a specific type of cell therapy.
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My leukemia tests positive for CD19.
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My condition has not improved despite treatment.
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My condition has worsened after initial improvement.
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My liver enzymes are within 5 times the normal limit.
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I haven't taken high doses of steroids within the last week.
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My lung function is at least half of what is expected, or my oxygen levels are good without extra oxygen.
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I have never been diagnosed with HIV.
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My leukemia has returned or is not responding to treatment and tests positive for CD19.
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I have not had a stem cell transplant from the same donor as my CAR T-cell therapy.
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I have received a stem cell transplant from the same donor as my CAR T-cell therapy.
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My condition has worsened or returned for at least the second time.
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I do not have leukemia in my brain causing symptoms.
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I am 18 years old or older.
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I do not have any severe, uncontrolled infections.
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My heart pumps well enough, meeting the minimum required efficiency.
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I have had a failed attempt at collecting my own stem cells.
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My condition did not improve after receiving additional treatment.
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I have a family member who is at least a half match for organ or tissue donation.
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I have been approved as a donor according to the required health regulations.
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My kidney function is within the required range for my age.
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I am 21 years old or younger.
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My condition worsened or didn't improve after CD19-CAR T-cell therapy.
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I am ineligible for a stem cell transplant as part of my first relapse treatment.
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I have had a failed attempt at making CAR T-cells from my own cells.
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My cancer did not respond to at least 2 rounds of strong chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after car t-cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after car t-cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose of allogeneic, CD19-CAR.CD45RA-negative cells

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
~690
CliniMACS
2005
Completed Phase 3
~770
Mesna
2003
Completed Phase 2
~1380
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,553 Total Patients Enrolled
Aimee C. Talleur, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
1 Previous Clinical Trials
26 Total Patients Enrolled
Stephen Gottschalk, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
5 Previous Clinical Trials
1,063 Total Patients Enrolled

Media Library

CD19-CAR(Mem) T-cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04881240 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Group A, Group B
Acute Lymphoblastic Leukemia Clinical Trial 2023: CD19-CAR(Mem) T-cells Highlights & Side Effects. Trial Name: NCT04881240 — Phase 1
CD19-CAR(Mem) T-cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04881240 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any prior investigations explored Leukapheresis as an approach?

"Presently, 893 clinical trials pertaining to Leukapheresis are ongoing. Of those investigations, 161 have advanced to the final stage of testing. Although most studies originate in Philadelphia, Pennsylvania there exist 28463 different locations running tests for this particular treatment."

Answered by AI

Does the FDA recognize Leukapheresis as a valid medical procedure?

"Limited supporting information regarding safety and efficacy puts the Leukapheresis at a score of 1 on our risk-assessment scale."

Answered by AI

Under what circumstances is Leukapheresis employed?

"Leukapheresis is primarily used to manage multiple sclerosis, but has also shown promise against certain forms of leukemia, myelocytic, acute and retinoblastoma as well as histiocytic lymphoma."

Answered by AI

What is the current enrollment of participants in this scientific experiment?

"Affirmative. Clinicaltrials.gov confirms that this medical trial, initially posted November 1st 2022 is actively recruiting participants at one site with the goal of enrolling 60 patients."

Answered by AI

Are there vacancies available for potential participants in this research project?

"The information presented on clinicaltrials.gov indicates that this medical trial is recruiting participants at the present time. The initial posting of this study occurred on November 1st 2022 and it was last revised October 11th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of CD19-directed Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia
2024. "Study of CD19-directed Allogeneic Memory T-cell Therapy for Relapsed/Refractory CD19+ Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04881240.
~40 spots leftby Jun 2026
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