35 Clinical Trials for Various Conditions
This study will enroll 6 DLT evaluable subjects (up to 12 patients total) where we will evaluate feasibility and safety of adoptive cellular therapy combined with IDH1/2 inhibitors in patients with recurrent or progressive oligodendroglioma WHO grade 2 and WHO grade 3.
This is an open-label phase 1 safety and feasibility study that will employ multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) derived from a patient's primary brain tumor tissues. Young patients with embryonal central nervous system (CNS) malignancies typically are unable to receive irradiation due to significant adverse effects and are treated with intensive chemotherapy followed by autologous stem cell rescue; however, despite intensive therapy, many of these patients relapse. In this study, individualized TSA-T cells will be generated against proteogenomically determined tumor-specific antigens after standard of care treatment in children less than 5 years of age with embryonal brain tumors. Correlative biological studies will measure clinical anti-tumor, immunological and biomarker effects.
The goal of this study is to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT). After completion of an open pilot, participants will be randomly assigned into one of two study intervention groups. The names of the study intervention groups involved in this study are: * Palliative care (PEACE) plus usual oncology care * Usual care (standard oncology care) Participation in this research study is expected to last for up to 2 years. It is expected that about 90 people will take part in this research study.
A Phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy (Total tumor mRNA-pulsed autologous Dendritic Cells (DCs) (TTRNA-DCs), Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) and Autologous G-CSF mobilized Hematopoietic Stem Cells (HSCs)).
This is a first-in-human dose escalation/dose expansion study to evaluate the safety and identify the best dose of modified immune cells, PRGN-3006 (autologous chimeric antigen receptor (CAR) T cells), in adult patients with relapsed or refractory acute myeloid leukemia (AML), Minimal Residual Disease (MRD) positive acute myeloid leukemia or higher risk myelodysplastic syndrome (MDS). Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.
The standard of care for children with DIPG includes focal radiotherapy (RT) but outcomes have remained dismal despite this treatment. The addition of oral Temozolomide (TMZ) concurrently with RT followed by monthly TMZ was also found to be safe but ineffective. Recent studies in adults have shown that certain types of chemotherapy induce a profound but transient lymphopenia (low blood lymphocytes) and vaccinating and/or the adoptive transfer of tumor-specific lymphocytes into the cancer patient during this lymphopenic state leads to dramatic T cell expansion and potent immunologic and clinical responses. Therefore, patients in this study will either receive concurrent TMZ during RT and immunotherapy during and after maintenance cycles of dose-intensive TMZ (Group A) or focal radiotherapy alone and immunotherapy without maintenance DI TMZ (Group B). Immune responses during cycles of DC vaccination with or without DI TMZ will be evaluated in both treatment groups.
It is believed that the body's immune system protects the body by attacking and killing tumor cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they recognize special proteins on the surface of tumors. In most patients with advanced cancer, T-cells are not stimulated enough to kill the tumor. In this research study, we will use a patient's tumor to make a vaccine which we hope will stimulate T-cells to kill tumor cells and leave normal cells alone. High grade gliomas (HGGs) are very aggressive and difficult for the body's immune system to attack. Before T-cells can become active against tumor cells, they require strong stimulation by special "stimulator" cells in the body called Dendritic Cells (DCs) which are also part of the immune system. DCs can recognize the cancer cells and then activate the T lymphocytes, and create this strong stimulation. The purpose of this research study is to learn whether anti-tumor T-cells and anti-tumor DC vaccines can be given safely. Most importantly, this study is also to determine whether the T-cells and DC vaccines can stimulate a person's immune system to fight off the tumor cells in the brain.
This study will evaluate the safety of autologous T cells that have been immunized ex vivo with patient-specific MDS stem cell neoantigens in patients with MDS.
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn about the safety and tolerability of 3 different doses of CD33-CAR-T cells (referred to throughout the consent as "T-cells") in patients who have CD33-positive acute myeloid leukemia (AML) that is relapsed (has come back) or refractory (has not responded to treatment). CD33-CAR-T is made by genetically modifying (changing) your T-cells (a type of white blood cell). T-cells are genetically changed to help target leukemia cells. This is an investigational study. CD33-CAR-T is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 39 participants will be enrolled in this study. All will take part at MD Anderson.
Background: - Individuals with cancer of the lung, chest cavity, ovary, or bladder, as well as patients who have been treated with adoptive cell therapy unfortunately commonly succumb to their disease. Some agree to donate their bodies to cancer research that may help the medical community better understand these diseases. Studies of cancer tumor tissue obtained soon after death may be used to answer questions about the origins, progression, and treatment of cancer. Researchers want to conduct a study that involves planned collection of cancer tumor tissue shortly after death. To do so, they will arrange to provide inpatient hospice care for people with lung cancer, ovarian cancer, bladder cancer, or patients who have been treated with adoptive cell therapy. \<TAB\> Objectives: - To collect cancer tissue biopsy samples as soon as possible after death. Eligibility: - Individuals who have cancer of the lung, chest cavity, ovary, or bladder, or those who have been treated with adoptive cell therapy and are planning to receive end-of-life hospice care are eligible to participate. Design: * Participants will agree to receive inpatient hospice care at the National Institutes of Health Clinical Center. Full details on end-of-life care preference will be acknowledged. * An autopsy will be performed at the clinical center within 3 hours of death. Tumor tissue will be collected from the primary site of cancer and from any areas of the body to which the cancer has spread. * Participants will not receive further cancer treatments as part of this study. This is a tissue collection study only....
This is a Phase 1/2 study to investigate the safety and efficacy of the CAR-T therapy, ONCT-808, in patients with relapsed/refractory (R/R) aggressive B cell malignancies.
The purpose of this study is to assess the safety and tolerability of escalating doses of RPTR-168 as a monotherapy in patients with HPV-16 E6/E7 positive tumors (HNSCC, cervical) and melanoma.
The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors that express melanoma-associated antigen 1 (MAGEA1).
The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).
The study purpose is to learn about the safety and tolerability of IMA101 alone (Cohort 1) or in combination with atezolizumab (Cohort 2) in patients with advanced solid cancers that express pre-defined Immatics tumor targets.
Background: - Sometimes after stem cells are transplanted, donor cells attack the recipient s cells and cause tissue damage. This is called acute graft-versus-host-disease (GVHD). Researchers want to see if bone marrow-derived mesenchymal stem cells (BMSC) can help treat GVHD. BMSC can travel in the body and help repair tissue. The BMSC in this study were grown from bone marrow from healthy volunteers. Objectives: - To test whether BMSC are safe to use soon after GVHD is diagnosed and to see how the body s immune system responds to BMSC. Eligibility: - People over 4 years old who had a stem cell transplant at NIH and now have acute GVHD. People who have had certain previous immunosuppressive therapy may be ineligible. Design: * Participants will be screened with medical history, physical exam, and blood tests. They will have a GVHD exam, including skin and stool tests. They must have a functioning central line. * Participation will last 11 weeks: 4 8 weeks of cell infusions, then follow-up for the rest of the weeks. * Up to 12 cell infusions: * Participants will come to the clinic twice weekly. * They will get medicine to prevent side effects (like Tylenol and Benadryl). * BMSC will be given through a small plastic tube in an arm vein or through an IV catheter. It will last 20 60 minutes. * Participants will be monitored for 1 hour. * Follow-up visits: Up to twice a week, participants will have physical exam and blood tests. They may have a GVHD exam. * Participants who have a tissue biopsy outside the study will be asked to send a sample to the study.
This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid diseases. Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28 patients will be enrolled for a total of 43 patients. Patients will be followed for disease response for 2 years.
The investigators intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from EBV positive HLA matched sibling or unrelated adult donor combined with post AlloSCT allogeneic donor derived LMP specific cytotoxic T-lymphocyte (CTL) infusions in EBV positive patients with poor risk Hodgkin Lymphoma. One of three reduced intensity conditioning regimens predetermined at each institutional center of the Childhood, Adolescent and Young Adult Lymphoma Cell Therapy Consortium (LCTC) will be utilized for related or matched unrelated adult donor allogeneic transplant followed by donor LMP specific CTL infusion for three doses post AlloSCT. The investigators hypothesize that the addition of donor derived LMP specific CTLs will be safe and feasible.
This is a Phase 1/2 study to test the safety, tolerability, and efficacy of the investigational agent MT-101 in patients with T cell Lymphoma. MT-101 is made with myeloid cells collected from the patient's blood. The myeloid cells are modified and later infused back into their veins. The modified myeloid cells recognize the tumor cells and are designed to target and kill them.
This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.
Patients undergoing immunotherapy for advanced cancer under IRB-approved protocols, who are to receive immune cells in adoptive transfer, will have less than or equal to 50% of those cells labeled with In-111-oxine and administered along with the remainder of their unlabeled cells. They will then undergo gamma-camera imaging over the next 0-7 days and blood samples and tumor sites which are accessible with minimal surgery (low-risk biopsy) may be sampled in some patients for enumeration of radiolabeled cells. End-points will be tumor and normal organ imaging and the amount of In-111 per gram of tissue in biopsies or per ml. of blood.
This phase I/II trial studies the side effects and how well localized radiation therapy or recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy works in treating patients with Merkel cell carcinoma that has spread to other parts of the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Interferon beta is a substance that can improve the body's natural response and may interfere with the growth of tumor cells. Monoclonal antibodies, such as avelumab, may help T lymphocytes kill tumor cells. For cellular adoptive immunotherapy, specific white blood cells are collected from the patient's blood and treated in the laboratory to recognize Merkel cell carcinoma. Infusing these cells back into the patient may help the body build an effective immune response to kill Merkel cell carcinoma. Giving localized radiation therapy or recombinant interferon beta and avelumab with or without cellular adoptive immunotherapy may be a better treatment for Merkel cell carcinoma.
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase I trial is studying the side effects of cellular adoptive immunotherapy in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes that relapsed after donor stem cell transplant.
A Phase 1/2, open-label study of a modified interleukin-2 fusion protein (IOV 3001) in participants with previously treated, unresectable or metastatic melanoma who will receive lifileucel.
This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).
This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.
This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).
This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic non-small-cell lung cancer
A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL \[LN-144/LN-145 (lifileucel)\] in combination with immune checkpoint inhibitors or TIL \[LN-144/LN-145 (lifileucel) and LN-145-S1\] as a single agent therapy.
This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.