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CAR T-cell Therapy

CART22 Therapy for B-Cell Leukemia

Phase 1
Recruiting
Led By Stephan Grupp, 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
Documentation of CD22 tumor expression in bone marrow or peripheral blood by flow cytometry at relapse
Relapsed or refractory B-cell ALL meeting specific criteria
Must not have
Progressive CNS3 disease or CNS parenchymal lesions increasing risk of CNS toxicity
HIV Infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment for kids with leukemia that has relapsed or is resistant to other treatments.

Who is the study for?
This trial is for children and young adults aged 1-29 with relapsed or refractory B-cell acute lymphoblastic leukemia. Participants must have adequate organ function, documented CD22 tumor expression, and agree to birth control if applicable. Excluded are those with HIV, active hepatitis B/C, certain CNS diseases, use of systemic steroids/immunosuppressants (with exceptions), pregnancy/nursing women, recent investigational drug use.
What is being tested?
The study tests a single dose of CART22 cells in pediatric patients. These cells are modified T cells engineered to target CD22 on leukemia cells using a special receptor called 'chimeric antigen receptors' with co-stimulatory domains TCRζ/4-1BB.
What are the potential side effects?
Potential side effects may include immune system reactions leading to inflammation in various organs, infusion-related reactions similar to allergic responses, fatigue due to the body's reaction to treatment, 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 cancer shows CD22 expression in my latest tests.
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My B-cell ALL has returned or didn't respond to treatment.
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I am between 1 and 29 years old.
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I can do most activities but may need help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My brain condition is worsening or increases my risk of brain side effects.
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I am HIV positive.
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I am currently receiving treatment for ongoing graft-versus-host disease.
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I have active hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS)
Secondary study objectives
Describe response in terms of minimal residual disease (MRD).
Overall Complete Remission Rate (ORR) at Day 28.
Percentage of manufacturing products that do not meet release criteria.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pediatric patients with relapsed or refractory B-cell acute lymphoblastic leukemiaExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cohort 1
2012
Completed Phase 2
~60
Cohort 3
2015
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,358 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
731 Previous Clinical Trials
8,472,771 Total Patients Enrolled
Stephan Grupp, MD, PhDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
81 Total Patients Enrolled

Media Library

CART22 cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02650414 — Phase 1
B-Cell Lymphoma Research Study Groups: Pediatric patients with relapsed or refractory B-cell acute lymphoblastic leukemia
B-Cell Lymphoma Clinical Trial 2023: CART22 cells Highlights & Side Effects. Trial Name: NCT02650414 — Phase 1
CART22 cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02650414 — Phase 1
~24 spots leftby Dec 2037
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