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CAR T-cell Therapy

Radiation Therapy Before CAR T-Cell Therapy for Lymphoma

Phase 1
Recruiting
Led By Lia Palomba, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial tests if radiation therapy before CAR T cell therapy is safe & effective for people with relapsed B cell lymphoma, and if it's a practical option.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation like skin irritation and fatigue, as well as those from CAR T-cell therapy which may involve fever, difficulty breathing, rapid heartbeat, headache and confusion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
number of patients who develop unanticipated severe toxicity events
Secondary outcome measures
number of patients who are able to receive comprehensive BRT prior to infusion of CAR T cells

Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiation Therapy Before CAR T Cell TherapyExperimental Treatment3 Interventions
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 Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,841 Total Patients Enrolled
Lia Palomba, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

CAR T-cell product (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05574114 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Radiation Therapy Before CAR T Cell Therapy
Non-Hodgkin's Lymphoma Clinical Trial 2023: CAR T-cell product Highlights & Side Effects. Trial Name: NCT05574114 — Phase 1
CAR T-cell product (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05574114 — Phase 1

Frequently Asked Questions

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

Are there any opportunities still available to enroll in this clinical trial?

"The clinical trial is presently recruiting for participants, with the initial posting occurring on October 5th 2022 and recent modifications being made as of November 2nd 2022."

Answered by AI

What risks do patients face when choosing to undergo Radiation Therapy prior to CAR T Cell Therapy?

"As this is a Phase 1 trial, with limited evidence for safety and efficacy, Power gave Radiation Therapy Before CAR T Cell Therapy a score of one on its scale from 1 to 3."

Answered by AI

What is the current cap for participants in this trial?

"Correct. Clinicaltrials.gov attests to the fact that this study, which was initially put up on October 5th 2022, is currently enrolling participants. A total of 26 individuals are needed from a single site for participation in this clinical trial."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma
2022. "A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05574114.
~10 spots leftby Oct 2025
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