Clinical Trials

Safety and Efficacy of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cells in Subjects with Relapsed or Refractory BAFFR-expressing B-cell Hematologic Malignancies

Jacksonville, FL

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Safety and Efficacy of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cells in Subjects with Relapsed or Refractory BAFFR-expressing B-cell Hematologic Malignancies

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to assess the safety and tolerability of escalating doses of MC10029 following lymphodepleting (LD) therapy in subjects with relapsed or refractory BAFFR-expressing B-cell hematologic malignancies to determine the recommended dose for phase 1b (dose expansion).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

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Site IRB:
- Jacksonville, Florida: 23-004166
NCT ID:
NCT06191887
Sponsor Protocol Number:
MC230807

A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Jacksonville, FL, Rochester, MN

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A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The goal of this study is to test A2B694, an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express MSLN and have lost HLA-A*02 expression.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information
Rochester, Minn.	Open for enrollment	View complete study & contact information

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Site IRB:
- Jacksonville, Florida: 24-000337
- Rochester, Minnesota: 24-000337
NCT ID:
NCT06051695
Sponsor Protocol Number:
A2B694-101

Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer

Rochester, MN

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Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

We will study the effects of photodynamic priming for pancreatic adenocarcinoma treatment. Prior to study treatment, the patient will undergo photodynamic therapy using endoscopic ultrasound or CT-guided fine needle aspirate to directly target the tumor. After recovery from the procedure, the patient will start pembrolizumab. These steps are hoped to enhance the effect of standard chemotherapy given to eradicate the tumor.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 23-009036
NCT ID:
NCT06381154
Sponsor Protocol Number:
MC230404

TheraSphere With and Without Durvalumab and Tremelimumab for HCC

Jacksonville, FL

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TheraSphere With and Without Durvalumab and Tremelimumab for HCC

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The objective of the ROWAN clinical study is to assess the the durability of local tumor control in Hepatocellular Carcinoma (HCC) patients who receive TheraSphere followed by durvalumab and tremelimumab, compared to those who receive TheraSphere treatment alone.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

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Site IRB:
- Jacksonville, Florida: 21-013179
NCT ID:
NCT05063565
Sponsor Protocol Number:
S2472

A Study to Evaluate Immunotherapy and Ovarian Function Among Pre-menopausal Melanoma Survivors

Rochester, MN

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A Study to Evaluate Immunotherapy and Ovarian Function Among Pre-menopausal Melanoma Survivors

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purposes of this study are to analyze the ovarian function of female premenopausal melanoma survivors who have undergone immunotherapy, and compare with data from age-matched controls, prospectively investigate ovarian function in premenopausal women with melanoma undergoing immunotherapy, and to identify the impact of ovarian function change on the frequency and function of CD8+ T cells during immunotherapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 20-010873
Sponsor Protocol Number:
20-010873

A Study to Evaluate Azacitidine Plus Venetoclax Induction Chemotherapy To Treat Acute Myeloid Leukemia Patients for T-cell Directed Immunotherapy

Jacksonville, FL

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A Study to Evaluate Azacitidine Plus Venetoclax Induction Chemotherapy To Treat Acute Myeloid Leukemia Patients for T-cell Directed Immunotherapy

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to evaluate immune profile of Acute Myeloid Leukemia (AML) patients receiving Venetoclax plus Azacitidine induction chemotherapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 20-011624
NCT ID:
NCT06279572
Sponsor Protocol Number:
20-011624

A2B101-101: Obtaining Solid Tumor Tissue from Subjects Having Surgical Resection for Certain Tumor Types and Leukapheresis for CAR T-cell Therapy Manufacturing

Rochester, MN, Jacksonville, FL

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A2B101-101: Obtaining Solid Tumor Tissue from Subjects Having Surgical Resection for Certain Tumor Types and Leukapheresis for CAR T-cell Therapy Manufacturing

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The primary objectives for this study are:

The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
Percentage of screened subjects experiencing loss of heterozygosity of HLA-A*02.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 21-009252
- Jacksonville, Florida: 21-009252
NCT ID:
NCT04981119
Sponsor Protocol Number:
A2B101-101

Evaluation of Outcomes in Metastatic Gastric and Esophageal Carcinoma in Relation to Immunotherapy

Rochester, MN

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Evaluation of Outcomes in Metastatic Gastric and Esophageal Carcinoma in Relation to Immunotherapy

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is:

To assess the efficacy of treatment with checkpoint inhibitors (Pembrolizumab or Nivolumab) in metastatic gastric and esophageal carcinoma through retrospective chart review.
To explore if response to checkpoint inhibitors is dependent on biomarkers on tumor tissue.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 18-000411
Sponsor Protocol Number:
18-000411

A Study to Predict Response to Virotherapy and Immunotherapy by Using an Ex-Vivo Three-Dimensional Patient-Derived Organoid Model of Pediatric Urological Cancers

Rochester, MN

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A Study to Predict Response to Virotherapy and Immunotherapy by Using an Ex-Vivo Three-Dimensional Patient-Derived Organoid Model of Pediatric Urological Cancers

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is threefold: the first aim is to use patient-derived fresh tumor tissue to create cell lines and 3D tumor models (i.e. organoids) that preserve the characteristics of the original tumor. The preservation of the original tumor's drug resistance/response profile will be a major focus of this aim. The second aim is to conduct high-throughput testing of various drugs (e.g., virotherapy, immunotherapy) on these cell lines and 3D tumor models. The completion of the second aim is an important step towards developing a platform that can help guide treatment decisions for future patients, based on the drug response observed in the cell lines and 3D tumor models. The third aim is to use pan-omics approaches (i.e., genomics, proteomics, metabolomics) to find markers of drug response based on the results of the high-throughput drug testing on the cell lines and 3D tumor models.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 19-002795
Sponsor Protocol Number:
19-002795

Innovative CAR-TIL immunotherapy against melanoma

Jacksonville, FL

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Innovative CAR-TIL immunotherapy against melanoma

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The chimeric antigen receptor (CAR) T-cell therapy is a revolutionary cellular immunotherapy strategy that has transformed the treatment of B cell malignancies by engineering T cells to recognize B cell specific tumor markers; however, attempts to treat solid tumors with CAR T-cells have identified unique challenges that have rendered CAR T cells less effective against these tumors. Conventional CARs are designed to target tumor-associated antigens, but antigenic heterogeneity and the variable nature of surface antigen expression provide escape mechanisms for solid tumors from CAR T-cell attack. [1, 2] The solid tumor stroma acts as an immunosuppressive cloud that impedes the homing of peripheral CAR T-cells into the tumor microenvironment (TME). The hostile TME can also drive CAR T-cells to functional exhaustion and metabolic dysfunction, thus blunting the therapeutic efficacy of CAR T-cells.[3] Oncolytic viruses or radiation that generate local inflammation in the TME have been shown to promote T cell homing and infiltration [4] but do not address the exhaustion of tumor infiltrating lymphocytes (TILs). The PD-1/PD-L1 cascade allows tumors to evade the immune system by suppressing T cell function within the TME. [5, 6] An ideal adoptive cellular therapy must possess the ability to not only return to the site of the tumor but must also retain cytotoxic potential after a recognition event. We present here a CAR design that allows PD-1 to recognize PD-L1 on the tumor; however, the intracellular CAR design is one that results in T cell activation as opposed to inhibition. We hypothesize that targeting melanoma with a PD-1 (MC9324) CAR TIL therapy would capitalize on the tumor homing machinery of the TIL to drive the CAR TIL to the tumor where engagement of the PD-1 domain of the CAR with PD-L1 on the tumor cell would result in T cell cytotoxic killing.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 22-013458
Sponsor Protocol Number:
MC9324

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Search Results 71-80 of 82 for

Safety and Efficacy of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cells in Subjects with Relapsed or Refractory BAFFR-expressing B-cell Hematologic Malignancies

A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer

TheraSphere With and Without Durvalumab and Tremelimumab for HCC

A Study to Evaluate Immunotherapy and Ovarian Function Among Pre-menopausal Melanoma Survivors

A Study to Evaluate Azacitidine Plus Venetoclax Induction Chemotherapy To Treat Acute Myeloid Leukemia Patients for T-cell Directed Immunotherapy

A2B101-101: Obtaining Solid Tumor Tissue from Subjects Having Surgical Resection for Certain Tumor Types and Leukapheresis for CAR T-cell Therapy Manufacturing

Evaluation of Outcomes in Metastatic Gastric and Esophageal Carcinoma in Relation to Immunotherapy

A Study to Predict Response to Virotherapy and Immunotherapy by Using an Ex-Vivo Three-Dimensional Patient-Derived Organoid Model of Pediatric Urological Cancers

Innovative CAR-TIL immunotherapy against melanoma

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