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Study To Evaluate The Safety, Tolerability And Antitumor Activity Of Anti-B7-H3 Car-T Cell Injection (TX103) In Subjects With Recurrent Or Progressive Grade 4 Glioma

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Study To Evaluate The Safety, Tolerability And Antitumor Activity Of Anti-B7-H3 Car-T Cell Injection (TX103) In Subjects With Recurrent Or Progressive Grade 4 Glioma

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 evaluate the safety and tolerability of Anti-B7-H3 CAR-T Cell Injection administered via intraventricular [ICV] delivery or intracavitary [ICT]/ ICV dual delivery in subjects with recurrent or progressive grade 4 glioma. To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for intracranial infusion of Anti-B7-H3 CAR-T Cell Injection.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information
Scottsdale/Phoenix, Ariz.	Contact us for the latest status
Jacksonville, Fla.	Contact us for the latest status

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Site IRB:
- Rochester, Minnesota: 25-001245
- Scottsdale/Phoenix, Arizona: 25-001245
- Jacksonville, Florida: 25-001245
NCT ID:
NCT06482905
Sponsor Protocol Number:
TX103T-RG008

A2B101-101: Obtaining Solid Tumor Tissue From Subjects Having Surgical Resection For Certain Tumor Types And Leukapheresis For CAR T-cell Therapy Manufacturing

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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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
Scottsdale/Phoenix, Ariz.	Open for enrollment
Jacksonville, Fla.	Open for enrollment

Print study details

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

Innovative CAR-TIL immunotherapy against melanoma

Jacksonville, FL
- See Details
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

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Site IRB:
Jacksonville, Florida: 22-013458

Sponsor Protocol Number:
MC9324
Bispecific Aptamer Engagers For Cancer Therapy

Jacksonville, FL
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Bispecific Aptamer Engagers For Cancer Therapy

About this study

The purpose of this work is to develop brain cancer-specific small synthetic oligonucleotides (aptamers) that easily cross the BBB and capable of forming distinct three-dimensional configurations, enabling them to bind to target molecules with high affinity and specificity. The scope of this work is to develop brain cancer specific aptamers and combine them with patient-derived autologous T cells to enhance the tumor targeted immune reaction.

Our three major project aims are the creation of the Bispecific Aptamer T Cell Engagers (BATE) (aim 1), the creation of autologous T cell – BATE (aim 2), and finally the combination of our BATE and/or PATE with PDL-1 targeted CART cells (aim 3) for evaluation of synergism.

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: 24-011165

Sponsor Protocol Number:
24-011165

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

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

Assessing the Psychosocial and Financial Impact of CAR-T on Survivors and Caregivers

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Assessing the Psychosocial and Financial Impact of CAR-T on Survivors and Caregivers

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

Although survivorship recommendations have been developed in areas such as lymphoma and stem cell transplant, the long-term effects of CAR-T therapy are unknown. In addition, relatively little is known about the psychosocial impact of CAR-T on survivors and their caregivers. Due to the intensive nature of CAR-T treatment and its unique side effects, including neurotoxicity in the acute setting and infections and financial burden in the long-term setting, a longitudinal study that assesses these issues in a quantitative and qualitative fashion is required. Consideration of both patient and caregiver needs is important for the provision of appropriate and effective health services, particularly in intensive cancer treatments that require a caregiver, such as CAR-T.

Our objective in this proposal is to define the long-term needs of CAR-T survivors using patient-reported health-related quality of life (QOL) measures, qualitative interviews, and adverse event data. The rationale for our proposed study is that it will provide the necessary knowledge on CAR-T survivor physical, mental, and social health to formulate a CAR-T specific survivorship program that can be implemented and studied in the future.

We aim to recruit 100 subjects (50 survivors and 50 caregivers) to the study. Inclusion Criteria are the following: age ≥ 18, blood cancer diagnosis (including B-ALL, multiple myeloma, and lymphoma), receiving a CAR-T product, able to complete a written questionnaire in English either independently or with assistance, and able to perform a verbal interview either in person or via phone teleconference. We will survey patients at baseline and then at pre-specified timepoints up to 2 years after CAR-T. Survey questionnaires that have been previously validated in cancer populations will be used to assess: overall quality of life, psychosocial impact, cognitive function, post-traumatic stress, spiritual well-being, and financial toxicity. Patient demographics, adverse events, and comorbidities will also be collected via survey and/or medical record review. A selected subset of participants (10 survivors and 10 caregivers) will be chosen to undergo semi-structured open ended interviewing to obtain a qualitative understanding of unmet needs, social support, and distress. Data will be analyzed and compared to historical lymphoma and transplant cohorts.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Contact us for the latest status	View complete study & contact information
Rochester, Minn.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Contact us for the latest status

Print study details

Site IRB:
- Jacksonville, Florida: 19-012702
- Rochester, Minnesota: 19-012702
- Scottsdale/Phoenix, Arizona: 19-012702

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Search Results 21-29 of 29 for

PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS

A Study to Evaluate the Safety and Effectiveness of Lisocatagene Maraleucel in Patients

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 Mesothelin-Targeting Logic-gated CAR T, In Participants With Solid Tumors That Express MSLN And Have Lost HLA-A*02 Expression

Study To Evaluate The Safety, Tolerability And Antitumor Activity Of Anti-B7-H3 Car-T Cell Injection (TX103) In Subjects With Recurrent Or Progressive Grade 4 Glioma

A2B101-101: Obtaining Solid Tumor Tissue From Subjects Having Surgical Resection For Certain Tumor Types And Leukapheresis For CAR T-cell Therapy Manufacturing

Innovative CAR-TIL immunotherapy against melanoma

Bispecific Aptamer Engagers For Cancer Therapy

Assessing the Psychosocial and Financial Impact of CAR-T on Survivors and Caregivers

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