HLA-A*0201 Positive Cells PresentPhase 1NCT03450122
Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma
A Phase 1 study testing Aldesleukin, Autologous NY-ESO-1-specific CD8-positive T Lymphocytes and Cyclophosphamide in people with HLA-A*0201 Positive Cells Present and NY-ESO-1 Positive Tumor Cells Present, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies how well autologous NY-ESO-1-specific CD8-positive T lymphocytes (modified T lymphocytes [T cells]), chemotherapy, and aldesleukin with or without dendritic cell-targeting lentiviral vector ID-LV305 (LV305) and immunotherapeutic combination product CMB305 (CMB305) work in treating… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HLA-A*0201 Positive Cells Present, NY-ESO-1 Positive Tumor Cells Present, Recurrent Myxoid Liposarcoma
- What is being tested?
- Aldesleukin, Autologous NY-ESO-1-specific CD8-positive T Lymphocytes and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2018to 6 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histopathologic documentation of synovial sarcoma or myxoid liposarcoma with the diagnosis of advanced or recurrent disease who have received prior standard chemotherapy. Patients with other sarcoma subtypes if proven to be NY-ESO-1 positive and meeting all other eligibility criteria listed below will also be included.
- Tumor expression of NY-ESO-1 (2+ staining or > 25%) by immunohistochemistry (IHC).
- Expression of HLA-A*0201.
- Eastern Cooperative Oncology Group (ECOG)/ Zubrod performance status of '0-1'
- Life expectancy > 6 months.
- Electrocardiography (ECG) without evidence of clinically significant arrhythmia or ischemia.
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- Women of childbearing potential (WOCBP) must be using at least one highly effective or two effective accepted methods of contraception to avoid conception throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion and/or at least 3 months after the study agents LV305 or CMB305 are stopped. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
- Men must be willing and able to use an acceptable method of birth control such as latex condom during the dosing period and for at least 3 months after completion of the study agent administration (T cell infusion and/or LV305 or CMB305) if their sexual partners are WOCBP.
- Willing and able to give informed consent.
- (Prior to treatment) Note: evaluate at least 1 week before T cell infusion. a. Adequate venous access - consider peripherally inserted central catheter (PICC) or central line. b. ECOG/Zubrod performance status of '0-1. c. Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, computed tomography [CT scan]). d. At least 4 weeks must have elapsed since the last chemotherapy, immunotherapy, radiotherapy or major surgery. At least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin. e. Toxicity related to prior therapy must either have returned to =< grade 1, baseline, or been deemed irreversible. f. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 3 months after study drug is stopped. g. Willing and able to give informed consent.
Who cannot join
- Patients with active infections or oral temperature > 38.2 Celsius (C) within 72 hours of leukapheresis. The procedure may be deferred.
- Investigational therapy within 3 weeks.
- Prior administration of other NY-ESO-1 targeting immunotherapeutics.
- Significant immunosuppression from concurrent, recent (=< 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti-inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy.
- Cancer therapies, including chemotherapy, radiation, biologic, or kinase inhibitors, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) within 3 weeks prior.
- Psychiatric, other medical illness or other condition that in the opinion of the principal investigator (PI) prevents compliance with study procedures or ability to provide valid informed consent.
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- Significant autoimmune disease with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapy.
- Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) grade III or IV heart failure.
- Peripheral blood leukocyte count (white blood cells [WBC]) < 3000/mm^3.
- Absolute neutrophil count =< 1500/mm^3.
- Platelets < 75000/mm^3.
- Hemoglobin < 10 gm/dL.
- Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN).
- Total serum bilirubin > 1.5 x ULN (patients with Gilbert's disease may be included if their total bilirubin is =< 3.0 mg/dL).
- Creatinine > 1.5 x ULN. If higher check 24hr clearance, if < 50 ml/min then patient will be excluded.
- INR (prothrombin time ratio) or partial thromboplastin time (PTT) > 1.5 x ULN (Please note: patients with hematopoietic cell transplantation (Hct) < 30%, WBC < 2500/mm/^3 and platelets < 50,000/mm^3 immediately prior to leukapheresis. The procedure may be deferred.)
- History of other cancer within 3 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ).
- Positive screening tests for human immunodeficiency virus (HIV), hepatitis (Hep) B, Hep C, active tuberculosis or recent (< 2 week ago) clinically significant infection or evidence of active HIV, Hep B, or Hep C. (Note: If positive results are not indicative of true active or chronic infection, the patient can be treated.)
- Brain metastases considered unstable as: a. without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR b. associated with symptoms and/or findings; OR c. requiring corticosteroids or anticonvulsants in the prior 60 days.
- Pregnant, planning to become pregnant, or breast feeding.
- Known allergy(ies) to any component of CMB305 or LV305.
- Men or women of reproductive ability who are unwilling to use effective contraception and women of childbearing potential who are unwilling to undergo pregnancy testing before and during the study.
- Clinically significant pulmonary dysfunction, as determined by medical history and physical exam. Patients so identified will undergo pulmonary functions testing and those with forced expiratory volume in 1 second (FEV1) < 2.0 L or carbon monoxide diffusing capability (DLco) (correlation for hemoglobin [corr for Hgb]) < 75% will be excluded.
- Significant cardiovascular abnormalities as defined by any one of the following: a. congestive heart failure, b. clinically significant hypotension, c. symptoms of coronary artery disease, d. presence of cardiac arrhythmias on electrocardiography (EKG) requiring drug therapy, e. ejection fraction < 50 % (dobutimine stress echo).
- Active and untreated central nervous system (CNS) metastasis.
- Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptable.
- Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy.
- No prisoners or children will be enrolled on this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ NYESO-1-Specific T Cells and the NY-ESO-1 Immunostimulatory Agents LV305 or CMB305 for Patients With Sarcoma
This phase I trial studies how well autologous NY-ESO-1-specific CD8-positive T lymphocytes (modified T lymphocytes [T cells]), chemotherapy, and aldesleukin with or without dendritic cell-targeting lentiviral vector ID-LV305 (LV305) and immunotherapeutic combination product CMB305 (CMB305) work in treating participants with sarcoma that has spread to other places in the body (advanced) or that has come back (recurrent). Modified T cells used in this study are taken from participants, are changed in a laboratory, and may "kill" some types of tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide may help the body get ready to receive the modified T cells. Interleukins, such as aldesleukin, are proteins made by white blood cells and other cells in the body and may help regulate immune response. LV305 and CMB305 may help stimulate the immune system. Giving modified T cells, chemotherapy, aldesleukin, LV305, and CMB305 may work better in treating participants with sarcoma.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the safety of adoptively transferred CD8 T cells targeting NY-ESO-1 positive (+) tumors given alone and in combination with antigen-specific vaccination.
II. Evaluate the functional and numeric in vivo persistence of NY-ESO-1-specific CD8 T-cells given alone and in combination with antigen-specific vaccination.
SECONDARY OBJECTIVES:
- Evaluate the anti-tumor efficacy achieved following adoptive transfer of NY-ESO-specific CD8 T cells in combination with LV305 alone and with G305 vaccine in patients with advanced synovial and mixed round cell liposarcoma.
II. Evaluate the influence of antigen-specific vaccination on the induction of both CD8 and CD4 T cells to NY-ESO-1 and non-targeted tumor-associated antigens (antigen-spreading) and the correlation of these responses with clinical outcome.
OUTLINE: Participants are assigned to 1 of 3 groups.
COHORT 0: Participants receive cyclophosphamide intravenously (IV) over 30-60 minutes on day -2 and autologous NY-ESO-1-specific CD8-positive T lymphocytes IV over 60 minutes on day 0. Then, 6 hours later and twice a day for 14 days, receive aldesleukin subcutaneously (SC) in the absence of disease progression or unacceptable toxicity.
COHORT 1: Participants receive cyclophosphamide, autologous NY-ESO-1-specific CD8-positive T lymphocytes, and aldesleukin as in Cohort 0. Participants also receive dendritic cell-targeting lentiviral vector ID-LV305 intradermally (ID) on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity.
After conclusion of study treatment, participants are followed up every 4 weeks for 168 days, then every 3 months for 24 months.
- Conditions
- HLA-A*0201 Positive Cells Present, NY-ESO-1 Positive Tumor Cells Present, Recurrent Myxoid Liposarcoma, Recurrent Synovial Sarcoma
- Being tested
- Aldesleukin, Autologous NY-ESO-1-specific CD8-positive T Lymphocytes, Cyclophosphamide, Dendritic Cell-targeting Lentiviral Vector ID-LV305
- Medical subject headings
- Liposarcoma, Myxoid, Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AldesleukinBiological
Also called 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2
Given SC
Autologous NY-ESO-1-specific CD8-positive T LymphocytesBiological
Given IV
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida
Given IV
Dendritic Cell-targeting Lentiviral Vector ID-LV305Biological
Also called DCvex-NY-ESO-1, ID-LV305
Given ID
| Study group | Role | What they receive |
|---|---|---|
| Cohort 0 (cyclophosphamide, T cells, aldesleukin) | Experimental | Participants receive cyclophosphamide IV over 30-60 minutes on day -2 and autologous NY-ESO-1-specific CD8-positive T lymphocytes IV over 60 minutes on day 0. Then, 6 hours later and twice a day for 14 days, receive aldesleukin SC in the absence of disease progression or unacceptable toxicity. Receives: Biological: Aldesleukin; Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes; Drug: Cyclophosphamide |
| Cohort 1 (cyclophosphamide, T cells, aldesleukin, LV305) | Experimental | Participants receive cyclophosphamide, autologous NY-ESO-1-specific CD8-positive T lymphocytes, and aldesleukin as in Cohort 0. Participants also receive dendritic cell-targeting lentiviral vector ID-LV305 ID on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity. Receives: Biological: Aldesleukin; Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes; Drug: Cyclophosphamide; Biological: Dendritic Cell-targeting Lentiviral Vector ID-LV305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of in vivo persistence of transferred T cells
Will be assessed alone or in combination with dendritic cell-targeting lentiviral vector ID-LV305 (LV305) or in combination with CMB305.
Measured: Up to 168 days
The nature, frequency and severity of adverse events
n subjects receiving NY-ESO-1-specific T cells alone, T cells with LV305 and T cells with CMB305
Measured: Up to 168 days
The Laboratory abnormalities
Will be assessed in subjects receiving NY-ESO-1-specific T cells alone, T cells with LV305 and T cells with CMB305
Measured: Up to 168 days
Secondary outcomes (4)
Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and RECIST-based immune-related response (irRC) data
CT/MRI will be evaluated per RECIST v1.1 and RECIST- based irRC
Measured: Up to 168 days
Persistence of cellular immune response
Research blood draws at specific intervals will be collected and analyze for these outcomes
Measured: Up to 168 days
Differentiation phenotype
Research blood draws at specific intervals will be collected and analyze for these outcomes
Measured: Up to 168 days
Antigen-spreading
Research blood draws at specific intervals will be collected and analyze for these outcomes
Measured: Up to 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start13 Sep 2018
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HLA-A*0201 Positive Cells PresentStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neeta Somaiah, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450122
- Sponsor's protocol ID
- 2017-0315
- Other IDs
- NCI-2018-00926, 2017-0315
- Status last verified
- Oct 2023
- First submitted
- 19 Feb 2018
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ NYESO-1-Specific T Cells and the NY-ESO-1 Immunostimulatory Agents LV305 or CMB305 for Patients With Sarcoma
- ClinicalTrials.gov ID
- NCT03450122
- Acronym / sponsor ID
- 2017-0315
- Conditions
- HLA-A*0201 Positive Cells Present, NY-ESO-1 Positive Tumor Cells Present, Recurrent Myxoid Liposarcoma, Recurrent Synovial Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 1 Mar 2018 (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.
This phase I trial studies how well autologous NY-ESO-1-specific CD8-positive T lymphocytes (modified T lymphocytes [T cells]), chemotherapy, and aldesleukin with or without dendritic cell-targeting lentiviral vector ID-LV305 (LV305) and immunotherapeutic combination product CMB305 (CMB305) work in treating participants with sarcoma that has spread to other places in the body (advanced) or that has come back (recurrent). Modified T cells used in this study are taken from participants, are changed in a laboratory, and may "kill" some types of tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide may help the body get ready to receive the modified T cells. Interleukins, such as aldesleukin, are proteins made by white blood cells and other cells in the body and may help regulate immune response. LV305 and CMB305 may help stimulate the immune system. Giving modified T cells, chemotherapy, aldesleukin, LV305, and CMB305 may work better in treating participants with sarcoma.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the safety of adoptively transferred CD8 T cells targeting NY-ESO-1 positive (+) tumors given alone and in combination with antigen-specific vaccination.
II. Evaluate the functional and numeric in vivo persistence of NY-ESO-1-specific CD8 T-cells given alone and in combination with antigen-specific vaccination.
SECONDARY OBJECTIVES:
- Evaluate the anti-tumor efficacy achieved following adoptive transfer of NY-ESO-specific CD8 T cells in combination with LV305 alone and with G305 vaccine in patients with advanced synovial and mixed round cell liposarcoma.
II. Evaluate the influence of antigen-specific vaccination on the induction of both CD8 and CD4 T cells to NY-ESO-1 and non-targeted tumor-associated antigens (antigen-spreading) and the correlation of these responses with clinical outcome.
OUTLINE: Participants are assigned to 1 of 3 groups.
COHORT 0: Participants receive cyclophosphamide intravenously (IV) over 30-60 minutes on day -2 and autologous NY-ESO-1-specific CD8-positive T lymphocytes IV over 60 minutes on day 0. Then, 6 hours later and twice a day for 14 days, receive aldesleukin subcutaneously (SC) in the absence of disease progression or unacceptable toxicity.
COHORT 1: Participants receive cyclophosphamide, autologous NY-ESO-1-specific CD8-positive T lymphocytes, and aldesleukin as in Cohort 0. Participants also receive dendritic cell-targeting lentiviral vector ID-LV305 intradermally (ID) on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity.
After conclusion of study treatment, participants are followed up every 4 weeks for 168 days, then every 3 months for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 0 (cyclophosphamide, T cells, aldesleukin) | Experimental | Biological: Aldesleukin, Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes, Drug: CyclophosphamideParticipants receive cyclophosphamide IV over 30-60 minutes on day -2 and autologous NY-ESO-1-specific CD8-positive T lymphocytes IV over 60 minutes on day 0. Then, 6 hours later and twice a day for 14 days, receive aldesleukin SC in the absence of disease progression or unacceptable toxicity. |
| Cohort 1 (cyclophosphamide, T cells, aldesleukin, LV305) | Experimental | Biological: Aldesleukin, Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes, Drug: Cyclophosphamide, Biological: Dendritic Cell-targeting Lentiviral Vector ID-LV305Participants receive cyclophosphamide, autologous NY-ESO-1-specific CD8-positive T lymphocytes, and aldesleukin as in Cohort 0. Participants also receive dendritic cell-targeting lentiviral vector ID-LV305 ID on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histopathologic documentation of synovial sarcoma or myxoid liposarcoma with the diagnosis of advanced or recurrent disease who have received prior standard chemotherapy. Patients with other sarcoma subtypes if proven to be NY-ESO-1 positive and meeting all other eligibility criteria listed below will also be included.
- Tumor expression of NY-ESO-1 (2+ staining or > 25%) by immunohistochemistry (IHC).
- Expression of HLA-A*0201.
- Eastern Cooperative Oncology Group (ECOG)/ Zubrod performance status of '0-1'
- Life expectancy > 6 months.
Key exclusion criteria (28 listed)
- Patients with active infections or oral temperature > 38.2 Celsius (C) within 72 hours of leukapheresis. The procedure may be deferred.
- Investigational therapy within 3 weeks.
- Prior administration of other NY-ESO-1 targeting immunotherapeutics.
- Significant immunosuppression from concurrent, recent (=< 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine (antihistamines, non-steroidal anti-inflammatory drugs and aspirin permitted) or conditions such as common variable hypogammaglobulinemia or exposures such as large field radiotherapy.
- Cancer therapies, including chemotherapy, radiation, biologic, or kinase inhibitors, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) within 3 weeks prior.
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 |
|---|---|---|
| AldesleukinAlso: 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2Given SC | Biological | Cohort 0 (cyclophosphamide, T cells, aldesleukin), Cohort 1 (cyclophosphamide, T cells, aldesleukin, LV305) |
| Autologous NY-ESO-1-specific CD8-positive T LymphocytesGiven IV | Biological | Cohort 0 (cyclophosphamide, T cells, aldesleukin), Cohort 1 (cyclophosphamide, T cells, aldesleukin, LV305) |
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, CiclofosfamidaGiven IV | Drug | Cohort 0 (cyclophosphamide, T cells, aldesleukin), Cohort 1 (cyclophosphamide, T cells, aldesleukin, LV305) |
| Dendritic Cell-targeting Lentiviral Vector ID-LV305Also: DCvex-NY-ESO-1, ID-LV305Given ID | Biological | Cohort 1 (cyclophosphamide, T cells, aldesleukin, LV305) |
Primary outcome
Duration of in vivo persistence of transferred T cells
Time frame: Up to 168 days
Will be assessed alone or in combination with dendritic cell-targeting lentiviral vector ID-LV305 (LV305) or in combination with CMB305.
The nature, frequency and severity of adverse events
Time frame: Up to 168 days
n subjects receiving NY-ESO-1-specific T cells alone, T cells with LV305 and T cells with CMB305
The Laboratory abnormalities
Time frame: Up to 168 days
Will be assessed in subjects receiving NY-ESO-1-specific T cells alone, T cells with LV305 and T cells with CMB305
4 secondary outcomes
Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and RECIST-based immune-related response (irRC) data
Time frame: Up to 168 days
Persistence of cellular immune response
Time frame: Up to 168 days
Differentiation phenotype
Time frame: Up to 168 days
Antigen-spreading
Time frame: Up to 168 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- MD Anderson Cancer Center WebsiteLink 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.
Neeta Somaiah 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 study testing Aldesleukin, Autologous NY-ESO-1-specific CD8-positive T Lymphocytes and Cyclophosphamide in people with HLA-A*0201 Positive Cells Present and NY-ESO-1 Positive Tumor Cells Present, 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 10 inclusion and 28 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: finished, as of the sponsor's last update on 16 Oct 2023. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of in vivo persistence of transferred T cells (time frame: Up to 168 days). The study lists 3 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 16 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.