Solid TumorPhase 1/2NCT05672459
A Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors
A Phase 1/2 study testing Single Injection of IVS-3001- Anti - HLA-G CAR-T cells, Fludarabine phosphate and Cyclophosphamide in people with Solid Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The proposed clinical study is a Phase 1/2a trial to investigate the safety, tolerability, pharmacokinetics and clinical activity of anti-HLA-G CAR-T cells IVS-3001 administered to subjects with previously treated, locally advanced, or metastatic solid tumors which are HLA-G positive (HLA-G+) - as determined by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Single Injection of IVS-3001- Anti - HLA-G CAR-T cells, Fludarabine phosphate and Cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 29 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old.
- 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.
- For Phase 2a, eligible subjects will be enrolled into indication-specific cohorts:
- Cohort 1: HLA-G+ clear cell renal cell carcinoma who failed or intolerant to checkpoint inhibitor (CPI) and tyrosine kinase inhibitor (TKI)
- Cohort 2: Epithelial ovarian carcinoma who failed or intolerant to platinum-based therapy, and should have failed or intolerant for PARP inhibitor if BRCA 1/2 mutated
- Cohort 3: Other HLA-G+ tumors (biomarker driven) who failed or intolerant to at least one prior line of therapy and for whom at discretion of treating physician there is no standard therapy to confer a clinical benefit
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- HLA-G expression on tumor cells (any level of expression is acceptable) as determined by immunohistochemistry (IHC) analysis on tumor biopsies using the 4H84 antibody [1, 2]
- Measurable disease (at least one target lesion) per RECIST v1.1 [3]
- Life expectancy >12 weeks.
- Availability of a pre-treatment tumor archived tissue specimen to test for HLA-G expression.
- In case an archival tissue is not available, patients should be willing to consent for pretreatment biopsy to screen for HLA-G expression.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 [4]
- Subjects must have adequate venous access for apheresis or agree to use of a central line for apheresis collection.
- Subject has adequate organ function:
- Cardiac: Left ventricular ejection fraction (LVEF) at rest must be >45%.
- Hematologic:
- Absolute lymphocyte count ≥ 300/μL.
- Absolute neutrophil count ≥ 1000/μL
- Platelets ≥ 75,000/μL
- Hemoglobin ≥ 8.0 g/dL.
- Hepatic:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN), or ≤ 3 x ULN if due to Gilbert's disease
- Serum aspartate aminotransferase and alanine aminotransferase ≤ 3x ULN, or ≤ 5 x ULN if liver metastases are present.
- Renal:
- Creatinine ≤ 1.5 x ULN or eGFR ≥ 50 ml/min
- From the time of Screening/Study Treatment ICF signature, a female subject must be either:
- Not of childbearing potential defined as:
- Postmenopausal (> 45 years of age with amenorrhea ≥ 12 months).
- Permanently sterilized.
- Otherwise, incapable of pregnancy.
- Of childbearing potential and agrees to use 2 highly effective methods of birth control (Effectiveness of Contraception Methods, Centers for Disease Control [CDC] 2018) before lymphodepletion and for at least 12 months after lymphodepletion
- From the time of Screening/Study Treatment ICF signature, male subjects with female partners of childbearing potential must agree to use 2 highly effective methods of birth control (Effectiveness of Contraception Methods, CDC 2018) for at least 12 months after the last dose of IVS-3001.
Who cannot join
- Subjects who meet any of the following criteria are NOT eligible for the study.
- Immunotherapy at enrollment and after. Note: Bridging therapies (including herbal therapies) other than immunotherapies are allowed from cell harvest to 2 weeks before lymphodepletion (5 weeks for nitrosoureas or mitomycin) or 5 half-lives, whichever is shorter and must be reported in the CRF.
- Palliative radiotherapy is permitted but treatment must be completed at least 2 weeks prior to the start of lymphodepletion.
- Symptomatic, untreated, or actively progressing central nervous system metastases (subjects with prior brain metastases treated at least 2 weeks prior to the planned IVS-3001 infusion who are clinically stable and do not require chronic corticosteroid treatment are allowed.
- Primary CNS tumors.
- History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or leptomeningeal disease.
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- Ongoing toxicities related to prior anticancer therapy that have not resolved to Grade ≤ 1 (other than alopecia). Note: Current unresolved Grade ≥ 2 non-hematologic toxicity may be allowed after discussing with the study Chair/Co-Chair.
- Participation in any investigational drug study within 4 weeks prior to cell infusion.
- Autoimmune disease, chronic infection or any disease requiring systemic immunosuppressive therapy (e.g., calcineurin inhibitors, methotrexate, immunosuppressive antibodies such as anti-IL-6 or anti-IL-6-receptor).
- Prior CAR T cell or other genetically modified T cell therapy.
- Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- Symptomatic congestive heart failure requiring treatment.
- Clinically significant cardiac arrhythmia.
- Uncontrolled hypertension Acute myocardial infarction or unstable angina pectoris within 6 months prior to enrollment.
- QTcF > 480 msec; or, marked limitation of physical activity due to symptoms, or unable to carry on any physical activity without discomfort (New York Heart Association Functional Class III-IV).
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to enrollment, or anticipation of the need for a major surgical procedure during the study.
- Received a vaccine containing live virus within 6 weeks prior the lymphodepletion.
- Treatment with systemic chronic steroid therapy (prednisone ≥ 10 mg/day or equivalent) or any other immunosuppressive therapy (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 7 days or 7 half- lives of the prescribed therapy, whichever is shorter, prior to the planned apheresis date.
- Note:
- The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
- Patients who receive low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
- Uncontrolled intercurrent illness including but not limited to poorly controlled hypertension or diabetes, or any medical condition determined by the investigator to be a risk for enrolling in the protocol.
- Untreated or active infection at the time of initial screening, within 72 hours before lymphodepletion or at the time of leukapheresis. Prior oral or IV antibiotics antifungals or antiviral medications must be completed at least 1 week prior to IVS-3001 infusion except for use of prophylactic antimicrobial agents.
- Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of Screening:
- Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test during Screening. Subjects with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBc Ab) test at screening are eligible for the study if HBV deoxyribonucleic acid (DNA) test is negative. If a subject has a negative HBsAg test and a positive total HBc Ab test at screening, an HBV DNA test should be performed HBV viral load must be less than 100 UI/mL evaluated by PCR
- Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test during Screening. The HCV RNA test will be performed only for subjects who have a positive HCV test. If patient infected with HBV the viral load must be less than 100 UI/mL evaluated by PCR.
- History of Grade ≥ 2 bleeding within 4 weeks.
- Subjects with symptomatic intrinsic lung disease
- Subject is a woman of child-bearing potential and is pregnant (positive serum β-human choriogonadotropin test at Baseline), planning to become pregnant within 12 months after lymphodepletion, or is breastfeeding.
- Subject is a man who plans to donate sperm or father a child within 12 months after lymphodepletion.
- History of second primary malignant disease with the following exceptions:
- Malignancies that were treated and have not recurred within 2 years prior to Screening.
- Completely resected basal cell or squamous cell skin cancers.
- Any malignancy considered to be indolent, not requiring therapy and with low metastatic potential.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2a, Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors
The proposed clinical study is a Phase 1/2a trial to investigate the safety, tolerability, pharmacokinetics and clinical activity of anti-HLA-G CAR-T cells IVS-3001 administered to subjects with previously treated, locally advanced, or metastatic solid tumors which are HLA-G positive (HLA-G+) - as determined by immunohistochemistry (IHC) analysis on tumor biopsies using the 4H84 antibody.
Read the detailed description
Primary Objectives:
IVS-3001 is an autologous CAR-T cell therapy targeting human leukocyte antigen (HLA-G)
- Phase 1: To determine the safety, tolerability and the recommended phase 2 dose (RP2D) of IVS-3001 in subjects with refractory or relapsed HLA-G+ solid tumors.
- Phase 2a: To evaluate the anti-tumor activity of IVS-3001 in selected HLA-G+ solid tumor types.
Secondary Objectives:
- To evaluate pharmacokinetic profile of IVS-3001: persistence, expansion.
- To evaluate the clinical activity of IVS-3001 in selected HLA-G+ solid tumor types.
- To assess the long-term safety of IVS-3001.
Exploratory Objectives:
- To explore functionality of IVS-3001 as well as immune biomarkers linked with IVS-3001 and their relationship with clinical response
- Conditions
- Solid Tumor
- Being tested
- Single Injection of IVS-3001- Anti - HLA-G CAR-T cells, Fludarabine phosphate, Cyclophosphamide, leukapheresis
- Keywords
- IVS-3001, CART, HLA-G, ccRCC-renal cell carcinoma, Kidney cancer, EOC-epithelial ovarian cancer
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Injection of IVS-3001- Anti - HLA-G CAR-T cellsDrug
Given by IV (vein)
Given by IV (vein)
CyclophosphamideDrug
Given by IV (vein)
leukapheresisProcedure or surgery
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation (Part 1) and Expansion (Part 2 ) | Experimental | Participants will receive IVS 3001 at the selected dose Participants will receive IVS 3001 at the recommended phase 2 dose Receives: Drug: Single Injection of IVS-3001- Anti - HLA-G CAR-T cells; Drug: Fludarabine phosphate; Drug: Cyclophosphamide; Procedure: leukapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion an average of 3 years.
. Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: through study completion an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start21 Jun 2023
- Primary completion29 Jun 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Invectys
- Responsible party
- Sponsor
- Investigators
- Aung Naing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672459
- Sponsor's protocol ID
- 2022-0261
- Other IDs
- NCI-2023-00020
- Status last verified
- Jun 2026
- First submitted
- 3 Jan 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors
- ClinicalTrials.gov ID
- NCT05672459
- Acronym / sponsor ID
- 2022-0261
- Conditions
- Solid Tumor
- Keywords
- IVS-3001, CART, HLA-G, ccRCC-renal cell carcinoma, Kidney cancer, EOC-epithelial ovarian cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Invectys
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 29 Jun 2028 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed clinical study is a Phase 1/2a trial to investigate the safety, tolerability, pharmacokinetics and clinical activity of anti-HLA-G CAR-T cells IVS-3001 administered to subjects with previously treated, locally advanced, or metastatic solid tumors which are HLA-G positive (HLA-G+) - as determined by immunohistochemistry (IHC) analysis on tumor biopsies using the 4H84 antibody.
Detailed description
Primary Objectives:
IVS-3001 is an autologous CAR-T cell therapy targeting human leukocyte antigen (HLA-G)
- Phase 1: To determine the safety, tolerability and the recommended phase 2 dose (RP2D) of IVS-3001 in subjects with refractory or relapsed HLA-G+ solid tumors.
- Phase 2a: To evaluate the anti-tumor activity of IVS-3001 in selected HLA-G+ solid tumor types.
Secondary Objectives:
- To evaluate pharmacokinetic profile of IVS-3001: persistence, expansion.
- To evaluate the clinical activity of IVS-3001 in selected HLA-G+ solid tumor types.
- To assess the long-term safety of IVS-3001.
Exploratory Objectives:
- To explore functionality of IVS-3001 as well as immune biomarkers linked with IVS-3001 and their relationship with clinical response
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation (Part 1) and Expansion (Part 2 ) | Experimental | Drug: Single Injection of IVS-3001- Anti - HLA-G CAR-T cells, Drug: Fludarabine phosphate, Drug: Cyclophosphamide, Procedure: leukapheresisParticipants will receive IVS 3001 at the selected dose Participants will receive IVS 3001 at the recommended phase 2 dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Age ≥18 years old.
- 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.
- HLA-G expression on tumor cells (any level of expression is acceptable) as determined by immunohistochemistry (IHC) analysis on tumor biopsies using the 4H84 antibody [1, 2]
- Measurable disease (at least one target lesion) per RECIST v1.1 [3]
- Life expectancy >12 weeks.
Key exclusion criteria (34 listed)
- Subjects who meet any of the following criteria are NOT eligible for the study.
- Immunotherapy at enrollment and after. Note: Bridging therapies (including herbal therapies) other than immunotherapies are allowed from cell harvest to 2 weeks before lymphodepletion (5 weeks for nitrosoureas or mitomycin) or 5 half-lives, whichever is shorter and must be reported in the CRF.
- Palliative radiotherapy is permitted but treatment must be completed at least 2 weeks prior to the start of lymphodepletion.
- Symptomatic, untreated, or actively progressing central nervous system metastases (subjects with prior brain metastases treated at least 2 weeks prior to the planned IVS-3001 infusion who are clinically stable and do not require chronic corticosteroid treatment are allowed.
- Primary CNS tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Injection of IVS-3001- Anti - HLA-G CAR-T cellsGiven by IV (vein) | Drug | Dose Escalation (Part 1) and Expansion (Part 2 ) |
| Fludarabine phosphateGiven by IV (vein) | Drug | Dose Escalation (Part 1) and Expansion (Part 2 ) |
| CyclophosphamideGiven by IV (vein) | Drug | Dose Escalation (Part 1) and Expansion (Part 2 ) |
| leukapheresisGiven by IV (vein) | Procedure or surgery | Dose Escalation (Part 1) and Expansion (Part 2 ) |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion an average of 3 years.
. Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: through study completion an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aung Naing, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Single Injection of IVS-3001- Anti - HLA-G CAR-T cells, Fludarabine phosphate and Cyclophosphamide in people with Solid Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion an average of 3 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.