Your session is about to expire
← Back to Search
CAR T-cell Therapy
CAR-T Cell Therapy for Solid Cancer
Phase 1 & 2
Recruiting
Led By Aung Naing, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 3 years
Awards & highlights
Study Summary
This trial will test a new cancer treatment for people with advanced solid tumors that are HLA-G positive.
Who is the study for?
Adults with advanced HLA-G-positive solid tumors that have not responded to standard treatments can join this trial. They must be in good enough health, with a life expectancy over 12 weeks and an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Participants need adequate organ function and agree to use effective birth control if applicable.Check my eligibility
What is being tested?
The trial is testing IVS-3001, a new type of CAR-T cell therapy targeting HLA-G on tumor cells. It's given after chemotherapy drugs Fludarabine and Cyclophosphamide prepare the body (lymphodepletion). The study will assess safety, how the body processes the treatment (pharmacokinetics), and its effectiveness against different types of solid tumors.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever, fatigue, changes in blood pressure; issues from high levels of inflammation like difficulty breathing; organ dysfunction; infusion-related reactions during treatment administration; and effects from pre-treatment chemotherapy like nausea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion an average of 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
. Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation (Part 1) and Expansion (Part 2 )Experimental Treatment4 Interventions
Participants will receive IVS 3001 at the selected dose Participants will receive IVS 3001 at the recommended phase 2 dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
leukapheresis
2004
Completed Phase 3
~230
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine phosphate
2007
Completed Phase 2
~360
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,357 Total Patients Enrolled
InvectysIndustry Sponsor
4 Previous Clinical Trials
112 Total Patients Enrolled
Aung Naing, MDPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,601 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had another type of cancer, but it's an exception.I have previously received CAR T cell or similar therapy.My tumor shows HLA-G expression.I have not received a live virus vaccine in the last 6 weeks.I am fully active or can carry out light work.I do not have any unmanaged ongoing illnesses.I have a stored tissue sample from before my treatment.I will be receiving immunotherapy during and after the trial.I do not have active hepatitis B or C, nor HIV.My cancer originated in the brain or spinal cord.I have heart problems that affect my daily activities.My side effects from previous cancer treatments are mild or gone.I have brain metastases that are untreated or getting worse.I have a significant brain or nervous system condition.I am 18 years old or older.My heart, blood, liver, and kidneys are all functioning well.I am pregnant, planning to become pregnant soon, or am breastfeeding.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I haven't taken steroids or immunosuppressants recently.I am a man planning to father a child within a year after my treatment.I have an autoimmune disease or need medicine that weakens my immune system.I finished palliative radiotherapy less than 2 weeks ago before starting lymphodepletion.My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.I agree to use two effective birth control methods for a year after my last dose.I have a lung condition that causes symptoms.I am willing to undergo a biopsy if I don't have existing tissue samples.I do not have an active infection.I have had significant bleeding in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation (Part 1) and Expansion (Part 2 )
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.
Are there any vacancies open for participants in this experiment?
"The information on clinicaltrials.gov indicates that enrollment for this particular trial is not currently taking place; however, the initial post was published on June 30th 2023 and last edited January 3rd 2023. Despite this specific study being closed to candidates at present time, there are still 2504 other studies actively seeking participants."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger