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CAR T-cell Therapy
CAR T-Cell Therapy for Leukemia
Phase 1 & 2
Recruiting
Led By Allison Barz Leahy, MD
Research Sponsored by Stephan Grupp MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a new manufacturing process is safe and effective to produce cells to treat B-ALL.
Who is the study for?
This trial is for children and young adults aged 0-29 with B-cell Acute Lymphoblastic Leukemia (B-ALL) who have either relapsed or didn't respond well to previous treatments. Participants must have CD19+ ALL, adequate organ function, and a performance score of at least 50. They should not be pregnant, nursing, or have active infections like hepatitis B/C or HIV.
What is being tested?
The study tests the safety and effectiveness of huCART19 T cells made using a new method called CliniMACS Prodigy platform in patients with B-ALL. It aims to see if this second-generation process can improve treatment outcomes for these patients.
What are the potential side effects?
Potential side effects may include immune system reactions, increased risk of infection due to altered immune responses, allergic reactions specific to cell therapy infusion, fatigue from treatment procedures, and possible complications related to bone marrow suppression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of huCART19 Administration
Safety of huCART19 Administration
Secondary study objectives
Anti-tumor response due to huCART19 cell infusions
Event Free Survival
Manufacturing Feasibility
+5 moreAwards & 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: Dose Expansion ArmsExperimental Treatment1 Intervention
If at least one dose level of the dose escalation phase is determined to be safe, the phase 2b dose expansion phase of the trial will be opened to enrollment. Subjects will receive the highest dose of huCART19 cells that were determined to be safe in the dose escalation part of the trial. 2 cohorts are planned:
* Cohort A (relapsed/refractory, CAR T cell naïve)
* Cohort B (prior treatment with CD19-directed CAR T cells)
Group II: Dose Escalation ArmExperimental Treatment1 Intervention
The phase 1 dose escalation portion of the trial will use a standard "3+3" design to establish the recommended phase 2 dose of huCART19 cells in patients with subjects with prior treatment with CD19-directed CAR T cells. Two dose escalations of huCART19 are planned for the dose escalation phase.
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaOTHER
731 Previous Clinical Trials
8,472,230 Total Patients Enrolled
Stephan Grupp MD PhDLead Sponsor
4 Previous Clinical Trials
224 Total Patients Enrolled
Allison Barz Leahy, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
Stephan Grupp, MD,PhDStudy DirectorChildren's Hospital of Philadelphia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain-related disease is responding to treatment.I currently have an infection that is not under control.My brain condition is getting worse despite treatment, or I have brain lesions that could make treatment risky.I am HIV positive.I had a poor response to previous B cell therapy.I am on medication for my seizure disorder.I am currently receiving treatment for graft-versus-host disease.My leukemia cells test positive for CD19.I have relapsed or refractory ALL or LBL.I can do most of my daily activities by myself.I had severe brain side effects from previous CAR T cell therapy.My organs are working well.I am 29 years old or younger.My cancer shows CD19 expression in tests after receiving CD19-targeted therapy.I am not on steroids or immunosuppressants that could affect cell therapy, except for necessary treatments or inhaled steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Arm
- Group 2: Dose Expansion Arms
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.