Your session is about to expire
← Back to Search
CAR T-cell Therapy
attIL12 T-Cell Therapy for Sarcoma
Phase 1
Recruiting
Led By John Livingston, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial will test a therapy to see if it can help control soft tissue or bone sarcoma.
Who is the study for?
This trial is for people aged 12 and older with advanced or metastatic soft tissue or bone sarcoma, who have tried at least one systemic therapy unless none exist for their subtype. They must be in good physical condition (ECOG status of 0 or 1), not pregnant, willing to use contraception, and have proper organ function. Exclusions include active infections like hepatitis B/C, autoimmune diseases within the past two years, untreated brain metastases, recent major surgery, HIV/AIDS, other cancer treatments ongoing or a second active malignancy.Check my eligibility
What is being tested?
The trial is testing attIL2-T cell therapy combined with Cyclophosphamide in patients with soft tissue or bone sarcomas. The goal is to determine a safe dosage that can control the disease. Participants will receive T-cells designed to target tumor cells directly.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs; symptoms from cyclophosphamide like nausea and low blood counts; increased risk of infection due to weakened immune defenses; and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To examine the incidence of adverse events.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B: Osteosarcoma Dose ExpansionExperimental Treatment2 Interventions
Participants will receive attIL2-T cell therapy at the recommended dose that was found in Phase 1.
Group II: Part A: Dose Findings (MTD)Experimental Treatment2 Interventions
The dose of attIL2-T cell therapy the participants will receive will depend on when the participants joined this study. The first group of participants will receive the lowest dose level of attIL2-T cell therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,356 Total Patients Enrolled
John Livingston, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
44 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 28 days.I have had a primary immunodeficiency, organ transplant, or tuberculosis.I am allergic to cyclophosphamide or the drugs being tested in this study.I have not had major surgery in the last 4 weeks or am still recovering from one.I have tested positive for HIV/AIDS.My osteosarcoma cannot be surgically removed and has come back or spread.My cancer has spread to my brain or spinal cord and hasn't been treated.I have another active cancer besides the one being treated.I do not have any unmanaged ongoing illnesses.I am 12 years old or older.My cancer is a confirmed advanced sarcoma in soft tissue or bone.I am willing to use birth control as required.I have had at least one treatment for sarcoma, unless there was no standard treatment available.I am fully active or can carry out light work.I am willing to have a core-needle biopsy.I don't have lasting side effects from cancer treatment, except for hair loss.My organ and bone marrow functions are within normal ranges.I agree to use birth control during the study.I am not currently on any cancer treatments like chemotherapy or immunotherapy.It's been over 3 weeks since my last chemotherapy or immunotherapy, or the appropriate time has passed since my last targeted therapy.It's been over 3 weeks since my last cancer treatment before my cell collection.I have a cognitive condition like Down syndrome but can still participate.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Dose Findings (MTD)
- Group 2: Part B: Osteosarcoma Dose Expansion
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.
Has the FDA sanctioned Part A: Dose Discoveries (MTD)?
"The safety of Part A: Dose Findings (MTD) is estimated to be a 1 due to the limited evidence from Phase 1 trials that supports efficacy and patient safety."
Answered by AI
Are there any opportunities to join this research project at the present moment?
"Unfortunately, according to clinicaltrials.gov this particular medical trial is not actively enrolling participants at the moment; it was initially posted on May 30th 2023 and last edited on 11/10/2022. Nevertheless, there are still 498 other studies that require volunteers currently."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger