Vancomycin + CAR-T for B-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment approach for individuals with large B-cell lymphoma, a type of blood cancer. Researchers aim to determine the safety and feasibility of using radiation and the antibiotic vancomycin before CAR-T cell therapy. CAR-T cell therapy modifies a patient’s immune cells to combat cancer. Participants must have a B-cell lymphoma diagnosis and plan to receive standard CAR-T treatment, with areas of their lymphoma that can be targeted by radiation. This trial is unsuitable for those unable to take vancomycin or with certain other health conditions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that the combination of vancomycin and radiation therapy was well tolerated, with patients generally not experiencing severe negative reactions. No serious side effects, such as Grade 3 or 4 adverse events, were reported. Vancomycin, used as an antibiotic, also showed potential to enhance the effects of cancer treatments.
CAR T-cell therapy involves modifying a patient’s immune cells to help them fight cancer more effectively. This treatment is already approved for some other conditions, indicating general safety. However, it can sometimes cause serious side effects, such as cytokine release syndrome (CRS), a strong immune response. Doctors are skilled at managing these effects.
Overall, past studies have shown that both vancomycin with radiation and CAR T-cell therapy are generally safe, with some manageable risks.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Vancomycin and CAR-T therapy for B-cell lymphoma because it introduces a unique approach to treatment. Most current treatments focus on chemotherapy and radiation, but this new therapy uses CAR-T cells, a type of immunotherapy that is engineered to specifically target and destroy cancer cells. Additionally, Vancomycin is being used here not just as an antibiotic but potentially to enhance the environment for CAR-T cells to work more effectively. This combination aims to offer a more targeted attack on lymphoma cells, potentially leading to better outcomes and reducing the chance of relapse.
What evidence suggests that this trial's treatments could be effective for B-cell lymphoma?
Research has shown that CAR T-cell therapy can effectively treat large B-cell lymphomas. Some studies reported that about 59% of patients achieved complete remission, with the average response lasting over 8 months. Longer-term results indicate that 30-40% of patients experience lasting remission or significant improvement. This treatment uses specially modified immune cells to locate and destroy cancer cells. While promising, it is important to be aware of possible side effects, such as cytokine release syndrome, which can cause fever and low blood pressure. In this trial, participants will receive a combination of vancomycin with radiation therapy and standard-of-care CD19 CAR T-cells.678910
Who Is on the Research Team?
Elise Chong, MD
Principal Investigator
Abramson Cancer Center, University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for adults (18+) with B-cell lymphoma who have at least one tumor that can be measured and treated with radiation. Participants must be eligible for standard CAR-T therapy, not need other immediate treatments, and women must not be pregnant.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation and Vancomycin Treatment
Participants receive vancomycin 125 mg orally four times per day, followed by standard of care radiation
CAR-T Therapy
Participants receive standard of care CD19 CAR T-cells
Follow-up
Participants are monitored for safety and effectiveness after CAR-T therapy
What Are the Treatments Tested in This Trial?
Interventions
- CAR-T
- Radiation
- Vancomycin
Trial Overview
The study tests if giving oral vancomycin and targeted radiation before standard CAR-T cell therapy is safe and possible in people with large B-cell lymphomas. All participants receive these treatments as part of the protocol.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
vancomycin 125 mg orally four times per day, followed by standard of care radiation and standard of care CD19 CAR T-cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abramson Cancer Center at Penn Medicine
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
1.
ashpublications.org
ashpublications.org/bloodadvances/article/9/24/6491/546491/Outcomes-of-CAR-T-cell-therapy-in-high-grade-BOutcomes of CAR T-cell therapy in high-grade B-cell ...
Anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for third-line aggressive large B-cell lymphomas (LBCL) resulted in long-term remission ...
Efficacy and safety of chimeric antigen receptor T-cell therapy ...
Only a few studies reported survival outcomes at 3, 18, 24, and 60 months. A publication mapping related to patient cohorts at different follow- ...
Long-term outcomes of CAR-T cell therapy in DLBCL.
Efficacy: Complete remission occurred in 59% with a median response duration of 8.3 months. Safety profile: CRS occurred in 100% of patients, ...
Long-term outcomes following CAR T cell therapy
The data demonstrate that CD19-targeted CAR T cells can induce prolonged remissions in patients with B cell malignancies, often with minimal long-term ...
5.
onco-hema.healthbooktimes.org
onco-hema.healthbooktimes.org/article/147867-the-emerging-role-of-car-t-cell-immunotherapy-in-early-treatment-of-large-b-cell-lymphomaThe Emerging Role of CAR T-Cell Immunotherapy in Early ...
By Guido Ghilardi. This review explores pivotal clinical trials that have driven the shift toward the earlier use of CAR T-cell immunotherapy in LBCL, ...
Immune System Modulation with Oral Vancomycin in ...
Our findings highlight vancomycin's safety, evidenced by the absence of Grade 3 or 4 adverse events, and its potential to enhance the antitumor ...
Vancomycin and Precision Radiation Therapy for the ...
This early phase I trial tests the safety and side effects of vancomycin and precision radiation therapy, such as stereotactic body radiation therapy (SBRT)
Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas
This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell ...
Enhancing outcomes in medically inoperable early-stage ...
The combination of vancomycin and SBRT was well tolerated, with no grade 3 or 4 adverse events reported. Vancomycin treatment selectively ...
Enhancing outcomes in medically inoperable early-stage ...
This study evaluated the safety and therapeutic potential of combining oral vancomycin-a non-absorbed, gut-restricted antibiotic with ...
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