CAR-NK Cells for Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment using special immune cells, called CAR-NK cells (a type of cell therapy), to combat certain relapsed or hard-to-treat blood cancers, including Hodgkin's lymphoma. The researchers aim to determine if these cells can safely and effectively target and destroy cancer cells in patients unresponsive to other treatments. Participants will receive chemotherapy followed by the CAR-NK cell treatment over two cycles. This trial may suit individuals with relapsed blood cancers who haven't succeeded with previous therapies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you have received any anti-cancer treatment within the last 2 weeks or are on certain immunosuppressive therapies. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that TGFBR2 KO CAR27/IL-15 NK cells are likely to be safe for humans?
Research has shown that a new treatment using specially engineered cells, called TGFBR2 KO CAR27/IL-15 NK cells, might be safe and well-tolerated for treating certain cancers. In earlier studies, researchers administered these cells to patients with recurrent or hard-to-treat cancers, such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), and the results were promising regarding safety.
These studies primarily aimed to determine a safe dose and observe patient responses to the treatment. The results indicated that patients tolerated the treatment well without serious side effects. However, this treatment remains in the early testing stages, so researchers are focused on ensuring safety and determining the optimal dose.
The TGFBR2 KO CAR27/IL-15 NK cells target and destroy specific cancer cells while attempting to spare healthy cells. This targeted approach aims to minimize harm to the patient, but careful monitoring during trials is crucial to ensure safety.12345Why do researchers think this study treatment might be promising for Hodgkin's Lymphoma?
Unlike the standard treatments for Hodgkin's Lymphoma, which often include chemotherapy and radiation, the TGFBR2 KO CAR27/IL-15 NK cells offer a novel approach by harnessing the body's immune system. This treatment uses genetically engineered Natural Killer (NK) cells that are designed to better recognize and destroy cancer cells. Researchers are excited because these modified NK cells are less likely to cause severe side effects and may improve targeting of cancer cells, potentially leading to more effective and safer treatment outcomes. The inclusion of IL-15, a cytokine, helps boost the activity and persistence of these NK cells, offering a promising new strategy against Hodgkin's Lymphoma.
What evidence suggests that TGFBR2 KO CAR27/IL-15 NK cells might be an effective treatment for Hodgkin's Lymphoma?
Studies have shown that specially engineered NK cells, known as TGFBR2 KO CAR27/IL-15 NK cells, might effectively fight cancer. In this trial, participants will receive these modified NK cells after lymphodepleting chemotherapy with Fludarabine and Cyclophosphamide. These cells enhance the natural ability of NK cells to locate and destroy cancer cells, particularly those with the CD70 protein. Research suggests that blocking the molecule TGF-β, which can weaken immune responses, boosts NK cell activity against cancer. Early results indicate that these modified NK cells can be safe and may help treat certain types of cancers that have returned or are resistant to treatment. Although still under study, the treatment shows promise in targeting and killing cancer cells.12678
Who Is on the Research Team?
Yago Nieto, MD, PHD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with certain types of relapsed or hard-to-treat lymphoid cancers (like Hodgkin's lymphoma, B-NHL, T-NHL, or B-ALL) who have measurable disease and good organ function. People can't join if they have active infections, recent major surgery, uncontrolled health issues, or are in complete remission.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Cycle 1
Participants receive lymphodepleting chemotherapy followed by infusion of TGFBR2 KO CAR27/IL-15 NK cells
Treatment Cycle 2
Participants receive a second cycle of lymphodepleting chemotherapy followed by infusion of TGFBR2 KO CAR27/IL-15 NK cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TGFBR2 KO CAR27/IL-15 NK cells
Trial Overview
The study tests a new treatment using specially engineered immune cells (CAR27/IL-15 NK cells with TGFBR2 knocked out), given after chemotherapy drugs fludarabine and cyclophosphamide. The goal is to see if this approach is safe for people whose cancer has come back or not responded to other treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Each treatment cycle will consist of lymphodepleting chemotherapy, followed by infusion of the TGFBR2 KO CAR27/IL-15 NK cells. Participants will be admitted to the inpatient service on day -6.
Each treatment cycle will consist of lymphodepleting chemotherapy, followed by infusion of the TGFBR2 KO CAR27/IL-15 NK cells. Participants will be admitted to the inpatient service on day -6.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
NCT06930651 | A Phase I/II Study of CAR.70-Engineered ...
The goal of this clinical research study is to find the recommended safe dose of TGFBR2 KO CAR27/IL-15 NK cells that can be given to patients with relapsed/ ...
Genetically Engineered Cells (TGFBR2 KO CAR27/IL-15 ...
Giving TGFBR2 KO CAR27/IL-15 NK cells may be safe, tolerable and/or effective in treating patients with relapsed or refractory AML, MDS or CMML. Eligibility ...
TGF-β Decreases NK Cell Mobility and Cytotoxic Efficacy in ...
Blocking TGF-β signaling has been shown to enhance NK cell activity against AML and colon cancer cells and improve AML cell elimination when ...
4.
cancer.gov
cancer.gov/publications/dictionaries/cancer-drug/def/allogeneic-tgfbr2-ko-car27-il-15-expressing-nk-cellsallogeneic TGFBR2 KO CAR27/IL-15-expressing NK cells
Upon administration, the allogeneic TGFBR2 KO CAR27/IL-15-expressing NK cells target, bind to and induce selective cytotoxicity in CD70-expressing tumor cells.
Generation of an Inhibitory NK Cell Subset by TGF-β1/IL-15 ...
CRISPR-mediated TGFBR2 knockout renders human ovarian cancer tumor-infiltrating lymphocytes resistant to TGF-β signaling. J. Immunother. Cancer 10: e003750.
Clinical Trials Using Allogeneic TGFBR2 KO CAR27/IL-15- ...
Review the clinical trials studying allogeneic tgfbr2 ko car27/il-15-expressing nk cells on this list and use the filters to refine the results by age and ...
TGFBR2 KO CAR27/IL-15 NK cells / UT MD Anderson ...
Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies ...
Disruption of TGF-β signaling pathway is required to mediate ...
These studies indicate that TGF-β signaling blockade is required for effective of NK cell or CAR-expressing NK cell-mediated killing of HCC and potentially ...
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