A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-05

Study Completion Date

2026-10-31

Brief Summary

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The purpose of this study is to test whether radiation therapy given before standard CAR T cell therapy is a safe and effective treatment for people with relapsed and refractory B cell lymphoma. The researchers will also study whether radiation therapy used in this study is a practical treatment option before standard CAR T cell therapy.

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Detailed Description

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Conditions

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Non-Hodgkin Lymphoma Non-Hodgkin's Lymphoma, Relapsed Non-Hodgkin's Lymphoma Refractory

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

This is a single arm, Phase I trial designed to describe the feasibility and safety of a standardized, stage-adapted, split-course BRT regimen prior to standard of care, commercial anti-CD19 CAR T-cell therapy. This design incorporates a small early safety cohort with the option for a potential patient expansion cohort.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiation Therapy Before CAR T Cell Therapy

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.

Group Type EXPERIMENTAL

Bridging radiotherapy (BRT)

Intervention Type RADIATION

RT Part I. The target will be to complete the 9th fraction of radiotherapy (i.e., total of 27Gy) between days -12 and -8 Day -2: BRT Part II (intervention is one fraction 3 Gy to receive a total dose of 3 Gy).

Conditioning chemotherapy

Intervention Type DRUG

Day -5 to -3: Patients will receive standard of care lymphodepleting chemotherapy

CAR T-cell product

Intervention Type BIOLOGICAL

Day 0: Subject will receive standard of care infusion of a manufactured commercial CAR T-cell product.

Interventions

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Bridging radiotherapy (BRT)

RT Part I. The target will be to complete the 9th fraction of radiotherapy (i.e., total of 27Gy) between days -12 and -8 Day -2: BRT Part II (intervention is one fraction 3 Gy to receive a total dose of 3 Gy).

Intervention Type RADIATION

Conditioning chemotherapy

Day -5 to -3: Patients will receive standard of care lymphodepleting chemotherapy

Intervention Type DRUG

CAR T-cell product

Day 0: Subject will receive standard of care infusion of a manufactured commercial CAR T-cell product.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed, relapsed or refractory non-Hodgkin lymphoma patients eligible for a CAR T-cell therapy, such as DLBCL (including transformed follicular lymphoma), high grade B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma of any grade
* Patient is approved for, and planned to receive, anyone of the three commercially available anti-CD19 CAR T-cell products (axicabtagene ciloleucel, maraleucel or tisagenlecleucel)
* Patient has at least one site of disease with avidity greater than liver on a screening FDG-PET scan performed within 2 months of RT simulation. Measurable disease is not required.
* Active secondary central nervous system (CNS) lymphoma is allowed
* Age 18 or older
* ECOG status ≤2
* Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from sexual activity for the course of the study through 120 days after the last dose of radiotherapy. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. Note: Abstinence is acceptable if this is the established and preferred contraception for the subject
* Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the established and preferred contraception for the subject

Exclusion Criteria

* Subject is planned to receive any systemic therapy after initiation of BRT and before re-infusion of CAR T cells including conventional chemotherapy, immunotherapy or targeted agents \[Note: Planned lymphodepletion chemotherapy in preparation for CAR T cell administration is not an exclusion criterion\]
* Subject has received prior RT to any site(s) planned for bridging therapy such that the composite dose considering the protocol-mandated BRT would exceed normal tissue tolerances in the determination of the investigator.
* The treating investigator deems that it would be impossible to comprehensively treat the patient with radiotherapy given concerns about feasibility or potential toxicities
* Current or planned pregnancy
* Known additional malignancy that is progressing or requires any treatment other than active surveillance or hormonal therapy. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
* Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study based on the investigator´s judgment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No