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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
Must not have
Active hepatitis B or active hepatitis C.
CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active hepatitis B or C.
Select...
My brain condition is worsening despite treatment, or I have brain lesions that could make treatment risky.
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I do not have any ongoing infections that aren’t responding to treatment.
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I am currently receiving treatment for active graft-versus-host disease.
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I am HIV positive.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Lymphoblastic Leukemia (ALL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while targeted therapy involves drugs that specifically target genetic mutations or proteins that contribute to cancer growth, such as tyrosine kinase inhibitors for Philadelphia chromosome-positive ALL. Immunotherapy, including treatments like huCART19 cells, redirects a patient's own T cells to target and destroy CD19-expressing B cells, which are often malignant in ALL. This approach is significant for ALL patients as it offers a highly specific attack on cancer cells, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,027 Previous Clinical Trials
42,885,611 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
712 Previous Clinical Trials
8,589,917 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
~0 spots leftby Aug 2024