← Back to Search

CAR T-cell Therapy

Radiation + CAR-T Therapy for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Michael Jain, MD, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No evidence or suspicion of active central nervous system (CNS) involvement of lymphoma.

Eligible to receive CAR T-cell therapy (axicabtagene ciloleucel) for LBCL and histological variants approved by the standard of care label.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

Study Summary

This trial studies the safety and effectiveness of radiation therapy before CAR T-cell therapy for large B-cell lymphoma patients with large tumors.

Who is the study for?

This trial is for adults with large B-cell lymphoma who have a lesion at least 5 cm big and are fit enough to undergo radiation therapy. They must not be pregnant, agree to use contraception, and cannot have HIV or active hepatitis. Those previously treated with CAR T-cell therapy or having heart issues, uncontrolled infections, or requiring steroids/immunosuppressants can't join.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of comprehensive bridging radiation therapy before CD19 CAR T-cell treatment in patients with bulky disease. It's an open-label phase 2 trial where all participants receive both treatments sequentially.See study design

What are the potential side effects?

Potential side effects include reactions related to radiation like skin irritation and fatigue, as well as those from CAR T-cell therapy such as flu-like symptoms, difficulty breathing, confusion, weakness on one side of the body, trouble speaking or thinking clearly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lymphoma has not spread to my brain or spinal cord.

Select...

I am eligible for a specific immune therapy (CAR T-cell) for my large B-cell lymphoma.

Select...

I can receive radiation therapy for all visible cancer areas.

Select...

I am a woman who cannot become pregnant due to surgery or menopause.

Select...

I have a large lesion that can be treated with radiation.

Select...

I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

Number of participants experiencing severe cytokine release syndrome (CRS)

Number of participants experiencing severe immune cell associated neurotoxicity syndrome (ICANS)

Number of serious adverse events attributed to CAR T-cell infusion

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation Therapy and CAR T-Cell InfusionExperimental Treatment2 Interventions

Following T-cell apheresis for CD19 CAR T-cell therapy, eligible enrolled study participants patients will undergo Comprehensive Ablative Bridging Irradiation (CABI) to all pretreatments lesions that are able to be feasibly and safely treated by the treating radiation oncologist. Upon completion of bridging radiotherapy, patients will undergo lymphodepleting chemotherapy period (Days -5, -4, -3) followed by axi-cel infusion (Day 0).

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,455 Total Patients Enrolled

Kite, A Gilead CompanyIndustry Sponsor

43 Previous Clinical Trials

3,629 Total Patients Enrolled

Michael Jain, MD, PhDPrincipal InvestigatorMoffitt Cancer Center

1 Previous Clinical Trials

27 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any grave risks associated with Radiation Therapy and CAR T-Cell Infusion?

"Because this Phase 2 trial does not yet have evidence to support efficacy, the safety score of Radiation Therapy and CAR T-Cell Infusion was given a rating of 2."

Answered by AI

What is the capacity of participants for this clinical research?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial is actively looking for participants, having been published on October 20th of 2024 and revised most recently on the 26th of the same month. The research team needs 27 volunteers from a single site to make this study successful."

Answered by AI

Are there currently openings for individuals to partake in this trial?

"Affirmative. As indicated on clinicaltrials.gov, this medical study is still in the process of recruiting participants; it was initially posted on October 20th 2023 and most recently updated on October 26th 2023. 27 individuals need to be enrolled from one site for the trial to continue."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL

2023. "Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06104592.