Can a burst of radiation make CAR t-cells fight cancer harder?
NCT ID NCT07725406
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial tests whether adding a small dose of total body radiation to standard CAR T-cell therapy can help the immune cells grow stronger and last longer in the body. It enrolls adults with relapsed or hard-to-treat diffuse large B-cell lymphoma or multiple myeloma who are already scheduled to receive a commercial CAR T-cell product. The goal is to see if the combination is safe and can improve the cancer-killing response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-dose total body irradiation added to standard CAR T-cell therapy (CD19 or BCMA-directed)
- What this could lead to
- If successful, this approach could make CAR T-cell therapy more effective and durable for patients with hard-to-treat blood cancers.
- What could go wrong
- This is an early-phase, dose-escalation trial with only 32 participants, so safety and effectiveness are not yet established. Adding radiation may increase side effects like cytokine release syndrome or bone marrow suppression.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: For Diffuse Large B-Cell Lymphoma (DLBCL) Cohort: * Diagnosis of DLBCL that is refractory to first-line chemoimmunotherapy, relapses within 12 months of first-line chemoimmunotherapy, relapses after 12 months in a transplant-ineligible patient, or is relapsed/refractory after two or more lines of systemic therapy. Eligible histologies include DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from indolent lymphoma (follicular lymphoma, marginal zone lymphoma, or chronic lymphocytic leukemia) * Age ≥18 years * ECOG performance status ≤2 * Measurable disease on PET/CT or CT per Lugano Criteria * Adequate organ function: ANC ≥1000 cells/mm³; platelet count ≥75,000 cells/mm³; creatinine clearance or eGFR ≥45 mL/min; total bilirubin ≤2.0x ULN; AST or ALT ≤3.0x ULN; left ventricular ejection fraction \>40% For Multiple Myeloma (MM) Cohort: * Relapsed or refractory multiple myeloma after ≥1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, with disease refractory to lenalidomide (progression within 60 days of last lenalidomide dose) * Age ≥18 years * ECOG performance status ≤2 * Adequate organ function: ANC ≥1000 cells/mm³; platelet count ≥75,000 cells/mm³; creatinine clearance or eGFR ≥30 mL/min; total bilirubin ≤2.0x ULN; AST or ALT ≤3.0x ULN; left ventricular ejection fraction \>40% Exclusion Criteria: For DLBCL Cohort: * History of previous total body irradiation * Prior CAR T-cell therapy * Clonal cytopenia of uncertain significance (CCUS) * Prior history of myeloid malignancies (MDS/AML or MPN), T-cell lymphoblastic lymphoma/leukemia, or B-cell acute lymphoblastic leukemia * Current or prior CNS involvement by lymphoma * Significant cardiovascular impairment (CHF greater than NYHA Class II, uncontrolled hypertension, unstable angina, MI or stroke within 6 months, or cardiac ventricular arrhythmia) * Decompensated cirrhosis * Active HIV, hepatitis B, or hepatitis C infection * Active uncontrolled systemic fungal, bacterial, or viral infection * Pregnancy For MM Cohort: * History of previous total body irradiation * History of myelodysplastic syndrome, CCUS, or concurrent active hematological malignancy with bone marrow involvement * Active HIV, hepatitis B, or hepatitis C infection * Active uncontrolled systemic fungal, bacterial, or viral infection * Prior CAR T-cell therapy * Active or history of CNS myeloma or leptomeningeal infiltration * Pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, 10065, United States