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CAR T-cell Therapy
CAR T Cell Therapy (AUTO3) for Diffuse Large B-Cell Lymphoma (ALEXANDER Trial)
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
ALEXANDER Trial Summary
This trial is testing a new cancer treatment that uses a person's own immune cells to target and kill cancer cells. The treatment will be given with an anti-cancer drug to help keep the cancer from coming back.
Who is the study for?
Adults (≥18 years) with Diffuse Large B-Cell Lymphoma, including transformed cases and those who've had at least one prior therapy. Participants must have adequate organ function, not be pregnant or breastfeeding, agree to use effective contraception, and cannot have certain heart conditions, active infections or a history of significant neurological disorders.Check my eligibility
What is being tested?
The trial is testing AUTO3, a CAR T cell therapy targeting two proteins on cancer cells (CD19/22), followed by anti-PD1 antibody treatment for a limited time. The goal is to see how safe it is and how well it works in patients with DLBCL who haven't responded well to other treatments.See study design
What are the potential side effects?
Potential side effects may include immune system reactions causing inflammation in various organs, infusion-related reactions like fever or chills, fatigue, blood count changes increasing infection risk. Specific risks will depend on individual responses to the CAR T cell therapy.
ALEXANDER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I Escalation - Safety (incidence of Grade 3-5 toxicities) and identification of recommended Phase II dose and schedule.
Phase I Expansion - Safety (incidence of Grade 3-5 toxicities) in the outpatient / ambulatory care setting
Phase II - Overall response rate as per Lugano criteria
Secondary outcome measures
Complete response rate, as per Lugano criteria.
Duration of response (DOR).
Feasibility of generating AUTO3: number of patients' cells successfully manufactured as a proportion of the number of patients undergoing leukapheresis.
+2 moreALEXANDER Trial Design
1Treatment groups
Experimental Treatment
Group I: AUTO3Experimental Treatment1 Intervention
Patient with relapsed or refractory DLBCL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AUTO3
2017
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
Autolus LimitedLead Sponsor
7 Previous Clinical Trials
924 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious heart condition that is not currently under control or you have experienced a heart problem within the past year.You have a type of cancer that is not responding to chemotherapy treatment.Your kidneys, liver, lungs, and heart must be working well.You have a history of optic neuritis or other immune or inflammatory diseases that affect the central nervous system.You are allergic to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide, fludarabine, pembrolizumab, or tocilizumab.You currently have a serious infection.Your disease has come back or gotten worse within a year of receiving a stem cell transplant from your own body.Your kidney or liver function has worsened since the start of the study.You have previously received a transplant of stem cells from another person.You currently have cancer that has spread to your central nervous system (brain or spinal cord). However, if you had cancer in your central nervous system in the past and it was effectively treated at least 4 weeks ago (or 8 weeks ago before receiving a specific treatment called AUTO3 infusion), you may still be eligible.You have a type of lymphoma called DLBCL that developed from another type of slow-growing lymphoma, but not from Richter's transformation.You have a heart rhythm problem that is not well controlled, except if you have atrial fibrillation that is being treated to control your heart rate.You have received antibody therapy, such as anti-CD20 therapy, within the past 2 weeks or within the time it takes for the antibody to be mostly eliminated from your body.You have experienced a relapse after trying at least two different treatments or after receiving an autologous stem cell transplant.
Research Study Groups:
This trial has the following groups:- Group 1: AUTO3
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How widespread is the implementation of this trial across multiple sites?
"At this moment, 7 medical sites are recruiting patients for the trial. These locales include New york, Nashville and Miami as well as 4 other cities. To reduce travel requirements, individuals should pick a clinic that is closest to their current residence if they wish to enroll."
Answered by AI
Is the research program still open to enrollees?
"The information on clinicaltrials.gov reveals that this research project is not presently enrolling patients; however, the trial was initially announced on September 5th 2017 and its last update occurred October 19th 2022. Despite this particular study no longer searching for participants, there are 1775 other trials actively recruiting right now."
Answered by AI
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