← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
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.

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.
Primary outcome measures
Phase II - Cohort IIA: ORR defined as proportion of patients achieving CR or CRi as assessed by an IRRC. Cohort IIB: Proportion of patients achieving MRD-negative remission by central ClonoSEQ NGS testing (<1e-4 leukemic cells)
Phase Ib - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion
Secondary outcome measures
Phase II - Complete remission rate
Phase II - Detection of CAR T cells measured by PCR following AUTO1 infusion
Phase II - Duration of severe hypogammaglobulinaemia
+6 more

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

AUTO1 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04404660 — Phase 1 & 2
B Cell Acute Lymphoblastic Leukemia Research Study Groups: AUTO1
B Cell Acute Lymphoblastic Leukemia Clinical Trial 2023: AUTO1 Highlights & Side Effects. Trial Name: NCT04404660 — Phase 1 & 2
AUTO1 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04404660 — Phase 1 & 2

Frequently Asked Questions

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

How many participants have been recruited for this experiment?

"Affirmative. According to clinicaltrials.gov, this ongoing medical trial was posted on March 4th 2020 and has since been updated as recently as August 26th 2022. Currently, 215 participants are needed between 27 different study sites."

Answered by AI

Does this experimentation currently seek participants?

"Affirmative. Clinicaltrials.gov records demonstrate that this trial, which was initially posted on March 4th 2020, is presently enrolling participants. 215 volunteers are required to be recruited from 27 separate sites."

Answered by AI

Are there many locations currently undertaking this clinical experiment in Canada?

"27 medical institutions are currently recruiting patients for this trial, including Memorial Sloan Kettering Cancer Center in New york, University of Chicago in Chicago, and University of Nebraska in Omaha. Additionally, 24 more clinical sites throughout the United States offer enrolment opportunities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
2020. "A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04404660.
~30 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top