A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 As Monotherapy Or In Combination With Either Nivolumab Or Pembrolizumab In HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
Trial tests new cell therapy for advanced cancers expressing MAGE-A4
Plain English Summary
ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS) is a Phase 1 clinical trial sponsored by USWM CT, LLC studying Endometrial Cancer, Esophageal Cancer, Esophagogastric Junction (EGJ), Gastric (Stomach) Cancer, Head and Neck Cancer, Melanoma, Ovarian Cancer, Non-small Cell Lung (NSCLC), Urothelial Cancer. This trial tests a new type of cell therapy called ADP-A2M4CD8, given alone or with other cancer drugs (nivolumab or pembrolizumab). It is for patients with certain advanced cancers (like lung, stomach, or head and neck) that have a specific marker (MAGE-A4) and a specific gene (HLA-A2). Participation involves receiving the cell therapy through an IV infusion, and patients will be monitored for side effects and how well the treatment works. Alternative treatments may include chemotherapy, radiation, surgery, or other targeted therapies depending on the cancer type and stage. The trial aims to enroll 120 participants.
Official Summary
This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 to 75 can join if their cancer has the MAGE-A4 marker and they have the HLA-A2 gene. Patients with specific cancers like lung, stomach, head and neck, melanoma, ovarian, urothelial, or endometrial cancer may be eligible. You cannot join if you have brain metastases, active autoimmune diseases, certain infections, or other specific medical conditions. Good general health and heart function are required, with a specific oxygen saturation level. This trial is studying Endometrial Cancer, Esophageal Cancer, Esophagogastric Junction (EGJ), Gastric (Stomach) Cancer, Head and Neck Cancer, Melanoma, Ovarian Cancer, Non-small Cell Lung (NSCLC), Urothelial Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures assess how safe the new cell therapy is and if patients can tolerate it, either on its own or with other drugs. The specific primary outcome measures are: To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab (2.5 years); To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab (Up to 15 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial explores a novel cell therapy approach for difficult-to-treat cancers that express the MAGE-A4 antigen, addressing a need for new treatment options. This research targets Endometrial Cancer, Esophageal Cancer, Esophagogastric Junction (EGJ), Gastric (Stomach) Cancer, Head and Neck Cancer, Melanoma, Ovarian Cancer, Non-small Cell Lung (NSCLC), Urothelial Cancer, where improved treatment options are needed.
Investor Insight
This trial investigates a personalized cell therapy targeting specific tumor markers, representing a growing area in oncology with potential for significant patient benefit and market impact. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if your cancer has the MAGE-A4 marker and if you have the HLA-A2 gene. Understand that the treatment involves collecting your own cells, modifying them, and then infusing them back into your body. Be prepared for regular clinic visits for infusions, blood tests, scans, and monitoring for side effects. The trial is being conducted at 17 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 120 participants
Interventions
- GENETIC: Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks — Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 alone or in combination with either nivolumab 480 mg IV every four weeks or pembrolizumab 400mg IV every 6 weeks
Primary Outcomes
- To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab (2.5 years)
- To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab (Up to 15 years)
Secondary Outcomes
- Anti-tumour activity: Overall Response Rate (ORR) (2.5 years)
- Anti-tumor activity: Best overall response (BOR) (2.5 years)
- Time to response (TTR) (2.5 years)
- Duration of Response (DOR) (2.5 years)
- Duration of stable disease (DoSD) (2.5 years)
Full Eligibility Criteria
* Key Inclusion criteria * Age ≥18 and ≤ 75 years * Subject is positive for at least 1 HLA-A\*02 inclusion allele * Histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal, esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck or ovarian cancer, endometrial cancer, melanoma * Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion. * Tumor shows MAGE-A4 expression as confirmed by central laboratory * ECOG Performance Status of 0 or 1. * Left ventricular ejection fraction (LVEF) ≥50% or the institutional lower limit of normal range, whichever is lower Note: other protocol defined Inclusion/Exclusion criteria may apply * Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline. Key exclusion criteria * Positive for any HLA-A\*02 allele other than: one of the inclusion alleles * History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study * Active autoimmune or immune mediated disease * Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases * Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease * Uncontrolled intercurrent illness * Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus * Pregnant or breastfeeding Note: other protocol defined Inclusion/Exclusion criteria may apply.
Trial Locations
- Name of Institution: Orlando Health Cancer Institute, Orlando, Florida, United States
- Massachusetts General Hospital, Boston, Massachusetts, United States
- Washington University - School of Medicine, St Louis, Missouri, United States
- Memorial Sloan Kettering Cancer Center, New York, New York, United States
- Duke University Medical Center, Duke Cancer Institute, Durham, North Carolina, United States
- OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
- Sarah Cannon Research Institute, Nashville, Tennessee, United States
- M.D. Anderson Cancer Center, Houston, Texas, United States
- Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
- Princess Margaret Cancer Centre, Toronto, Ontario, Canada
- ...and 7 more locations
Frequently Asked Questions
What is clinical trial NCT04044859?
NCT04044859 is a Phase 1 INTERVENTIONAL study titled "ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)." It is currently active, not recruiting and is sponsored by USWM CT, LLC. The trial targets enrollment of 120 participants.
What conditions does NCT04044859 study?
This trial investigates treatments for Endometrial Cancer, Esophageal Cancer, Esophagogastric Junction (EGJ), Gastric (Stomach) Cancer, Head and Neck Cancer, Melanoma, Ovarian Cancer, Non-small Cell Lung (NSCLC), Urothelial Cancer. The primary condition under study is Endometrial Cancer.
What treatments are being tested in NCT04044859?
The interventions being studied include: Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks (GENETIC). Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 alone or in combination with either nivolumab 480 mg IV every four weeks or pembrolizumab 400mg IV every 6 weeks
What does Phase 1 mean for NCT04044859?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT04044859?
This trial is currently "Active, Not Recruiting." It started on 2019-08-20. The estimated completion date is 2037-04-30.
Who is sponsoring NCT04044859?
NCT04044859 is sponsored by USWM CT, LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04044859?
The trial aims to enroll 120 participants. The trial status is active, not recruiting.
How is NCT04044859 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT04044859?
The primary outcome measures are: To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab (2.5 years); To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab (Up to 15 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04044859 being conducted?
This trial is being conducted at 17 sites, including Orlando, Florida; Boston, Massachusetts; St Louis, Missouri; New York, New York and 13 more sites (United States, Canada, Spain).
Where can I find official information about NCT04044859?
The official record for NCT04044859 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04044859. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04044859 testing in simple terms?
This trial tests a new type of cell therapy called ADP-A2M4CD8, given alone or with other cancer drugs (nivolumab or pembrolizumab). It is for patients with certain advanced cancers (like lung, stomach, or head and neck) that have a specific marker (MAGE-A4) and a specific gene (HLA-A2).
Why is this trial significant?
This trial explores a novel cell therapy approach for difficult-to-treat cancers that express the MAGE-A4 antigen, addressing a need for new treatment options.
What are the potential risks of participating in NCT04044859?
Common side effects may include fatigue, fever, nausea, and low blood cell counts. More serious risks can include severe allergic reactions, cytokine release syndrome (a strong immune response), and effects on the nervous system. The treatment involves a procedure to collect your cells (leukapheresis) which has its own risks. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04044859?
Ask your doctor if your cancer has the MAGE-A4 marker and if you have the HLA-A2 gene. Understand that the treatment involves collecting your own cells, modifying them, and then infusing them back into your body. Be prepared for regular clinic visits for infusions, blood tests, scans, and monitoring for side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04044859 signal from an investment perspective?
This trial investigates a personalized cell therapy targeting specific tumor markers, representing a growing area in oncology with potential for significant patient benefit and market impact. This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves receiving the cell therapy through an IV infusion, and patients will be monitored for side effects and how well the treatment works. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.