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 Center

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 below
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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 weeks
Treatment ~ Varies
Follow ups ~ through study completion an average of 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of 3 years for reporting.

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 Center
12 Previous Clinical Trials
1,601 Total Patients Enrolled

Media Library

IVS-3001 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05672459 — Phase 1 & 2
Solid Tumors Research Study Groups: Dose Escalation (Part 1) and Expansion (Part 2 )
Solid Tumors Clinical Trial 2023: IVS-3001 Highlights & Side Effects. Trial Name: NCT05672459 — Phase 1 & 2
IVS-3001 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05672459 — Phase 1 & 2

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
~78 spots leftby Jun 2026