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CAR T-cell Therapy

huCART19 for Acute Lymphoblastic Leukemia

Phase 2
Waitlist Available
Led By Shannon Maude, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ii. First marrow relapse of B-ALL at < 36 months from diagnosis OR iii. 2nd or greater relapse OR
CD19+ relapse after prior cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new treatment for leukemia that uses the patient's own T cells that have been modified to target and kill leukemia cells.

Who is the study for?
This trial is for children and young adults aged 1-29 with high-risk B-cell acute lymphoblastic leukemia (B-ALL) that hasn't responded well to other treatments, or has come back after treatment. Participants must have CD19+ cancer cells, be in good enough health to undergo the therapy, and agree to use birth control if they can have children.Check my eligibility
What is being tested?
The study tests huCART19, a type of immunotherapy where a patient's own T cells are modified to target CD19 on leukemia cells. It focuses on those with very poor prognosis using standard chemotherapy or who've had an inadequate response or relapse after previous cell therapies.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system attacking normal cells by mistake (autoimmune responses), symptoms at the infusion site, tiredness, digestive issues like nausea or diarrhea, blood-related problems such as anemia or clotting issues, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My B-ALL has relapsed for the first time in less than 3 years or I've had multiple relapses.
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My cancer returned after cell therapy and is CD19 positive.
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My B-cell ALL has returned or is not responding to treatment.
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I have very high-risk B-ALL or high-risk relapsed B-ALL.
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I cannot have a stem cell transplant from a donor.
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My previous cell therapy didn't fully work.
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My cancer still shows CD19 after treatment targeting CD19.
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My condition has worsened or returned at least twice after treatment.
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My recent blood cancer diagnosis did not respond to initial treatment.
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My kidney function, based on my age and gender, is normal.
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My cancer did not respond to at least 2 initial treatments or 1 re-treatment.
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My disease did not respond to at least 2 initial treatments or 1 re-treatment.
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I have no health issues that prevent me from undergoing a stem cell transplant.
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My cancer still shows CD19 after treatment.
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My leukemia did not respond to initial treatment.
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I am mostly active and can do things for myself.
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I am between 3 months and 29 years old.
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I have had a stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
1-year Event-Free Survival in patients with newly diagnosed VHR B-ALL or high-risk relapse of B-ALL
1-year Event-Free Survival in patients with poor response to prior B cell directed engineered cell therapy
Secondary outcome measures
2-year Event-Free Survival in patients with newly diagnosed VHR B-ALL or high-risk relapse of B-ALL (cohort A).
2-year Event-Free Survival in patients with poor response to prior B cell directed engineered cell therapy (cohort B)
2-year Relapse-Free Survival in patients with newly diagnosed VHR B-ALL or high-risk relapse of B-ALL (cohort A).
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Poor Response to Prior B Cell Directed Engineered cell therapyExperimental Treatment1 Intervention
Group II: Newly Diagnosed VHR B-ALL or High-Risk Relapse of BExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
huCART19
2014
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,879,988 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
707 Previous Clinical Trials
8,581,191 Total Patients Enrolled
Shannon Maude, MD, PhDPrincipal InvestigatorChildren's Hospital of Philadelphia

Media Library

huCART19 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03792633 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Newly Diagnosed VHR B-ALL or High-Risk Relapse of B, Poor Response to Prior B Cell Directed Engineered cell therapy
Acute Lymphoblastic Leukemia Clinical Trial 2023: huCART19 Highlights & Side Effects. Trial Name: NCT03792633 — Phase 2
huCART19 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03792633 — Phase 2

Frequently Asked Questions

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

Are there any vacancies available for participants in this clinical trial?

"Affirmative. The information published on clinicaltrials.gov states that this medical trial is currently recruiting participants, which began January 18th 2019 and was last updated July 21st 2022. Sixty-three people are required to fulfill the study's needs at a single location."

Answered by AI

What is the limit to the number of participants being recruited for this research effort?

"Indeed. Clinicaltrials.gov displays that the trial, initially published on 18th January 2019 and recently modified on 21st July 2022 is currently accepting participants. 63 individuals are requested at a solitary location to participate in this clinical study."

Answered by AI

Does this research support elderly participants?

"This clinical study is inviting individuals aged 3 months to 29 years old to participate."

Answered by AI

Is huCART19 a viable option for treating patients with minimal risk?

"We rate the safety of huCART19 as a 2, since it is in Phase 2 and there is some evidence confirming its security but no confirmation that it works."

Answered by AI

What is the eligibility criteria for individuals wishing to participate in this clinical investigation?

"This clinical trial seeks 63 participants aged 3 months to 29 years old with leukemia or lymphoid malignancies. Candidates must also fulfill a number of additional requirements, such as signing an informed consent form, having adequate performance status and pulmonary reserve, being free from certain comorbidities and contraindications to allogeneic stem cell transplantation (SCT), documenting CD19 tumor expression in bone marrow or other tissues through flow cytometry at relapse, passing serum creatinine tests based on age/gender criteria and exhibiting left ventricular shortening fraction (LVSF) ≥ 28% or ejection fraction (LVEF"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL
2019. "Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03792633.
~5 spots leftby Aug 2024
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