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Low-Dose Radiation with CAR T-Cell Therapy for Lymphoma and Myeloma

This study is testing a new way to combine CAR T-cell therapy with a small amount of radiation, called low-dose total body irradiation (LD-TBI), for people with diffuse large B-cell lymphoma (DLBCL) or multiple myeloma (MM) that has come back or not responded to previous treatments. The CAR T-cell therapies being used are Lisocabtagene Maraleucel or Axicabtagene Ciloleucel for DLBCL, and Ciltacabtagene Autoleucel for MM. Researchers believe this combination might help the CAR T-cells work better and last longer by making your immune system more active against cancer. The main goal is to see how safe this combination is, especially looking at any serious side effects within 28 days after CAR T-cell infusion. You may be eligible if you have DLBCL that is difficult to treat or has returned after initial therapies.

Study design
This is a single-center, open-label (everyone knows what treatment is given), non-randomized Phase Ib study with about 32 participants. It uses a 3+3 dose-escalation design to find the safest dose of radiation.
What's involved
Participants will have T-cells removed, receive chemotherapy (Cyclophosphamide, Fludarabine, or Bendamustine), then LD-TBI, and finally the CAR T-cell infusion. You will be followed for 2 years after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2 years after receiving the CAR T-cell therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07725406

Low-Dose TBI Plus CAR T-Cell Therapy for Relapsed/Refractory DLBCL and Multiple Myeloma

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Weill Medical College of Cornell University
~32 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Lymphodepleting chemotherapy: CyclophosphamideLymphodepleting chemotherapy: BendamustineLymphodepleting chemotherapy: FludarabineLisocabtagene MaraleucelAxicabtagene CiloleucelCiltacabtagene Autoleucel

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose-Limiting Toxicities (DLTs)
Measured over Through Day 28 post-CAR T cell infusion

Conditions

Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Relapsed or Refractory Multiple Myeloma (MM)

Explore related trials

Diffuse Large B-Cell LymphomaMultiple Myeloma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Caitlin Gribbin, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Nicole Santos, MPH
[email protected]
646-962-6827
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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%
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

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
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

What this trial measures

  • Incidence of Dose-Limiting Toxicities (DLTs)Through Day 28 post-CAR T cell infusion

    This outcome measures the number of participants experiencing a dose-limiting toxicity (DLT) at each LD-TBI dose level, within 28 days following CAR T-cell infusion. This measure is used to assess the safety and tolerability of the treatment regimen across escalating radiation dose levels and to determine the maximum tolerated dose (MTD).