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CAR T-cell Therapy
CAR T Cell Therapy for Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by Autolus Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase II: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1E-3 by central ClonoSEQ® NGS testing and <5% blasts in the BM at screening
Documented CD19 positivity within 1 month of screening
Must not have
Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management
Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for leukemia that involves genetically engineering a patient's own T cells to attack the cancer.
Who is the study for?
Adults over 18 with B cell acute lymphoblastic leukemia that's come back or hasn't responded to treatment. They must have a certain level of cancer cells in their bone marrow, be relatively healthy (ECOG status 0 or 1), and not have severe infections or other specific blood diseases. People with heart, liver, kidney, or lung problems can't join.
What is being tested?
The trial is testing AUTO1, a CAR T cell therapy designed to target CD19 on cancer cells in adults with relapsed/refractory B-ALL. It aims to see how safe it is and how well it works at different stages of the disease.
What are the potential side effects?
CAR T cell therapies like AUTO1 may cause symptoms such as fever, fatigue, headache, difficulty breathing, rapid heartbeat and low blood pressure. Some people might experience more serious effects affecting the brain or immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in my 2nd or later complete remission, with minimal disease detected and less than 5% cancer cells in my bone marrow.
Select...
My cancer was confirmed to be CD19 positive within the last month.
Select...
I am fully active or can carry out light work.
Select...
My B cell ALL has returned or is not responding to treatment.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently fighting an infection that needs strong medication.
Select...
I have had CD19 therapy but not blinatumomab, or I had severe side effects from blinatumomab.
Select...
I have been diagnosed with Burkitt's leukemia/lymphoma or CML in blast crisis.
Select...
I have Hepatitis B or C.
Select...
My leukemia is in an early phase and affects areas outside the bone marrow.
Select...
My cancer has spread to my brain and is affecting my nervous system.
Select...
I have a significant brain or spinal cord condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: AUTO1Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Autolus LimitedLead Sponsor
7 Previous Clinical Trials
844 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney, liver, lung, and heart functions are all within normal ranges.I am in my 2nd or later complete remission, with minimal disease detected and less than 5% cancer cells in my bone marrow.My cancer was confirmed to be CD19 positive within the last month.I am fully active or can carry out light work.My B cell ALL has returned or is not responding to treatment.I have Ph+ ALL and cannot tolerate or have not responded to at least two TKI treatments.I am 18 years old or older.I am currently fighting an infection that needs strong medication.I have had CD19 therapy but not blinatumomab, or I had severe side effects from blinatumomab.I have been diagnosed with Burkitt's leukemia/lymphoma or CML in blast crisis.I have Hepatitis B or C.My leukemia is in an early phase and affects areas outside the bone marrow.My cancer has spread to my brain and is affecting my nervous system.I have a significant brain or spinal cord condition.
Research Study Groups:
This trial has the following groups:- Group 1: AUTO1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.