CAR T-cell Therapy
Dose Escalation (Part 1) and Expansion (Part 2 ) for Solid Tumors
M D Anderson Cancer Center, Houston, TX
Single Injection of IVS-3001- Anti - HLA-G CAR-T cells +3 morePhase 1 & 2RecruitingLed by Aung Naing, MDResearch Sponsored by M.D. Anderson Cancer CenterEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or pathologically confirmed diagnosis of a locally advanced unresectable or metastatic HLA-G+ select solid tumor malignancy who failed or intolerant to standard of care therapies known to confer clinical benefit per treating physician.
- Cohort 1: HLA-G+ clear cell renal cell carcinoma who failed or intolerant to checkpoint inhibitor (CPI) and tyrosine kinase inhibitor (TKI)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow upsthrough study completion an average of 3 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will test a new cancer treatment for people with advanced solid tumors that are HLA-G positive.
Eligible Conditions
- Solid Tumors
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have a confirmed diagnosis of an advanced cancer that cannot be surgically removed. You have tried and didn't respond well or couldn't tolerate the standard treatments recommended by your doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow ups ~ through study completion an average of 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ 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
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: 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
Fludarabine phosphate
2007
Completed Phase 2
~360
Cyclophosphamide
1995
Completed Phase 3
~3790
leukapheresis
2004
Completed Phase 3
~230
Find a site
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,872 Previous Clinical Trials
1,780,822 Total Patients Enrolled
InvectysIndustry Sponsor
4 Previous Clinical Trials
112 Total Patients Enrolled
Aung Naing, MDPrincipal Investigator
M.D. Anderson Cancer Center12 Previous Clinical Trials
1,601 Total Patients Enrolled
Media Library
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