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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of huCART19 Administration
Safety of huCART19 Administration
Secondary outcome measures
Anti-tumor response due to huCART19 cell infusions
Event Free Survival
Manufacturing Feasibility
+5 more

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
708 Previous Clinical Trials
8,582,731 Total Patients Enrolled
Stephan Grupp MD PhDLead Sponsor
4 Previous Clinical Trials
224 Total Patients Enrolled
Stephan Grupp, MD,PhDStudy DirectorChildren's Hospital of Philadelphia

Media Library

Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05480449 — Phase 1 & 2
Acute Lymphoblastic Leukemia Research Study Groups: Dose Escalation Arm, Dose Expansion Arms
Acute Lymphoblastic Leukemia Clinical Trial 2023: Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19) Highlights & Side Effects. Trial Name: NCT05480449 — Phase 1 & 2
Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells (huCART19) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05480449 — Phase 1 & 2

Frequently Asked Questions

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

To date, how many people have signed up to be a part of this research project?

"That is correct. The information on clinicaltrials.gov does show that this particular trial is looking for participants at the moment. This trial was first posted on 9/20/2022 and was last updated on 10/5/2022. They are searching for a total of 89 patients from 1 site."

Answered by AI

Are there any current vacancies for this experimental treatment program?

"Presently, this clinical trial is seeking enrolment from patients. All information regarding the study was first posted on September 20th, 2022 with the most recent edit taking place on October 5th, 2022."

Answered by AI

Will this research project be considering any volunteers who are not yet seventy years old?

"The age range for participants in this clinical trial is 0 to 29 years old. Out of all the 477 similar studies, this one focuses on a younger patient demographic. There are 1229 trials for patients over 65 years old."

Answered by AI

What benefits are researchers hoping to achieve from this clinical trial?

"The primary outcome of this study is the safety of huCART19 administration, which will be assessed over a period of approximately 5 years. Secondary outcomes include remission rate (defined as the overall remission rate among treated subjects at Day 28 post-huCART19 infusion), manufacturing feasibility (defined as the percentage of manufactured products that meet release criteria for vector transduction efficiency, T cell product purity, viability, and sterility), and event-free survival (defined as 1-year Event-Free Survival in subjects with relapsed/refractory B-ALL [Cohort A] and in subjects with poor response to"

Answered by AI

How do I sign up for the research study?

"This study is seeking to enroll 89 young patients, aged 0-29, who have b-lymphocytes and meet the following additional inclusion criteria: Signed informed consent, relapsed or refractory ALL or Lly, poor response to prior B cell directed engineered cell therapy, CNS3 disease responsive to therapy , CD19 tumor expression in bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry , age 0-29 years old , adequate organ function , adequate performance status defined as Lansky or Karnofsky performance score ≥50. Subjects of reproductive potential must agree to use acceptable birth"

Answered by AI
~59 spots leftby Sep 2027