Radiation Therapy Before CAR T-Cell Therapy for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether adding radiation therapy before standard CAR T-cell therapy can safely and effectively treat certain types of lymphoma that have returned or are resistant to treatment. The focus is on B cell lymphoma, a type of blood cancer, and determining if this new approach can enhance the effectiveness of CAR T-cell therapy, a form of immunotherapy. Suitable candidates have a diagnosis of relapsed or stubborn non-Hodgkin lymphoma and plan to receive one of the available CAR T-cell therapies. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot receive any systemic therapy (like chemotherapy or immunotherapy) after starting the radiation therapy and before the CAR T-cell therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using radiation therapy before CAR T-cell therapy is safe for patients with lymphoma. One study found that this method did not cause additional side effects and did not reduce the effectiveness of CAR T-cell therapy. Another review described radiation as a safe and beneficial step before CAR T-cell treatment or if CAR T-cell therapy does not work as expected. Overall, these findings suggest that patients tolerate radiation before CAR T-cell therapy well.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about using radiation therapy before CAR T-cell therapy for lymphoma because it introduces a novel approach that may enhance the effectiveness of CAR T-cells. Unlike standard treatments that typically rely on chemotherapy alone to prepare the body, this method uses a two-part radiation therapy to potentially make the cancer cells more susceptible to attack by the CAR T-cells. This combination could lead to better targeting of the lymphoma cells, potentially improving outcomes for patients. Additionally, the flexibility in the lymphodepleting regimen offers personalized treatment, tailored to individual patient needs.
What evidence suggests that radiation therapy before CAR T-cell therapy could be an effective treatment for lymphoma?
Research has shown that using radiation therapy before CAR T-cell therapy can effectively treat lymphoma. In this trial, participants will receive radiation therapy prior to CAR T-cell therapy. Studies have found that radiation therapy can safely enhance results when combined with CAR T-cell therapy. It prepares the body for CAR T-cell treatment, which targets and destroys cancer cells. Previous data indicated that this combination does not increase side effects or reduce the effectiveness of CAR T-cell therapy. Additionally, radiation therapy can boost the activity of CAR T-cells, enhancing their ability to fight cancer. This combined approach is under further study to confirm its benefits for patients with relapsed or hard-to-treat B-cell lymphoma.24678
Who Is on the Research Team?
M. Lia Palomba, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Adults with relapsed or refractory B cell lymphoma, eligible for CAR T-cell therapy, can join this trial. They must have a certain level of blood counts and be willing to use birth control. People who've had prior radiation in the same area, are pregnant or planning pregnancy, need other systemic therapies before CAR T-cells, or have another progressing cancer can't participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation Therapy Part I
Participants receive 9 fractions of 3 Gy to a total dose of 27 Gy
Re-evaluation and Recovery
Recovery period with protocol-mandated reassessment including PET scan and biopsy
Radiation Therapy Part II
Participants receive one fraction of 3 Gy
CAR T-Cell Infusion
Standard of care infusion of a manufactured commercial CAR T-cell product
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CAR T-cell product
- Radiation Therapy
Trial Overview
The study is testing if giving radiation therapy before standard CAR T-cell therapy improves outcomes for B cell lymphoma patients. It's checking the safety and practicality of this approach compared to just the standard treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
For the purposes of this protocol, day 0 will be considered the date of planned CAR T infusion. BRT Part I (intervention is 9 fractions of 3 Gy to a total dose of 27 Gy). Post-BRT Phase I re- evaluation period: Following delivery of the first 9- fractions of BRT, patients will have a period for recovery, and undergo protocol-mandated reassessment (e.g., PET scan and biopsy). Patients will receive standard of care lymphodepleting chemotherapy. Substitutions to the lymphodepleting regimen will be permitted at the discretion of the treating investigator. Day -2: BRT Part II (intervention is one fraction 3 Gy to receive a total dose of 3 Gy). Day -1: No protocol scheduled treatment interventions. Day 0: Subject will receive standard of care infusion of a manufactured commercial CAR T-cell product, as an inpatient or outpatient, at the discretion of the treating investigator.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Published Research Related to This Trial
Citations
The Role of Radiotherapy in Lymphoma Patients ...
Radiation therapy has emerged as a safe and effective tool for either bridging to CAR T therapy or as early salvage therapy after CAR T failure.
Radiation therapy prior to CAR T-cell therapy in lymphoma
The use of bridging or salvage radiotherapy (RT) in combination with CAR T-cell therapy has been proposed as potential strategies to improve patient outcomes.
3.
ashpublications.org
ashpublications.org/bloodadvances/article/9/13/3293/536662/Bridging-radiotherapy-before-chimeric-antigenBridging radiotherapy before chimeric antigen receptor T cells ...
Br-RT before CAR-T was well tolerated with minimal toxicity in this large multicenter study. Comprehensive Br-RT and LDH normalization after RT but before ...
Outcomes with bridging radiation therapy prior to chimeric ...
Prior data demonstrates that bRT is safe and does not impose additional toxicity (8), does not compromise the therapeutic efficacy of CAR T-cell ...
Radiation therapy improves CAR T cell activity in acute ...
Radiation therapy (RT) has been successfully employed to circumvent the loss of CAR targets in preclinical models of pancreatic cancer.
Radiotherapy plus CAR-T cell therapy to date
In this review, we provide a deep insight into the radioresistance mechanisms, advances, and barriers of CAR-T cells in response to solid tumors within TME.
Combination of CAR‑T cell therapy and radiotherapy
This review focuses on the obstacles to the application of CAR-T technology in solid tumor therapy, the potential opportunities and challenges of combined ...
N/A DF/HCC Protocol #: 19-861 TITLE: Radiation Therapy ...
The primary objectives of this study are to evaluate the safety and toxicity of radiotherapy in patients with hematologic malignancies who will undergo any CD19 ...
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