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CAR T-cell Therapy

CAR T Cell Therapy for Leukemia and Lymphoma

Phase 1
Recruiting
Research Sponsored by Autolus Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients < 18 years old at screening
B ALL Cohort: r/r CD19-positive B ALL meeting specific criteria such as primary refractory disease, high risk infant ALL, relapsed or refractory disease after multiple lines of therapy, and Philadelphia chromosome positive disease
Must not have
Diagnosis of chronic myelogenous leukemia lymphoid in blast crisis
History or presence of clinically relevant central nervous system (CNS) pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Summary

This trial will test the safety and effectiveness of using modified T cells to target specific markers in children with certain types of leukemia and lymphoma that haven't responded to treatment.

Who is the study for?
This trial is for pediatric patients under 18 with relapsed or refractory B-cell acute lymphoblastic leukemia (B ALL) and aggressive mature B-cell non-Hodgkin lymphoma (B NHL). They must have tried at least two systemic therapies, weigh more than 6 kg, and have a performance status score of ≥50%. It's not for those who've had certain treatments less than three months ago or don't meet other specific health criteria.
What is being tested?
The study tests AUTO1, a CAR T cell therapy targeting CD19 in children with specific types of blood cancer that haven't responded to previous treatments. The aim is to see how safe it is and how well it works against these cancers.
What are the potential side effects?
CAR T cell therapy like AUTO1 can cause side effects such as fever, fatigue, headache, difficulty breathing, low blood pressure, and may affect normal cells leading to anemia or infections. More serious but less common risks include neurological events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 18 years old.
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My B-cell ALL is CD19 positive and has not responded well to treatments.
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I weigh at least 6 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a specific type of leukemia in an advanced stage.
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I have a significant brain or nerve condition.
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I had a stem cell transplant less than 3 months ago.
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I have had severe side effects from blinatumomab treatment.
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My brain or spinal cord cancer has worsened or caused changes in my nervous system.
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I am currently fighting an infection that needs strong medication.
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I have received treatment targeting CD19 before, but not blinatumomab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Overall remission rate (ORR) in B ALL patients
Overall response rate (ORR) in B NHL patients

Trial Design

1Treatment groups
Experimental Treatment
Group I: AUTO1Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Autolus LimitedLead Sponsor
7 Previous Clinical Trials
973 Total Patients Enrolled
~16 spots leftby Nov 2027
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