NCT07725406RecruitingPhase 1
Low-Dose TBI Plus CAR T-Cell Therapy for Relapsed/Refractory DLBCL and Multiple Myeloma
A Phase Ib, Dose-Escalation Study of Augmented Lymphodepletion and CAR T-cell Priming With Low-dose Total Body Irradiation in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphomas and Multiple Myeloma Receiving Treatment With Commercial CD19 or BCMA-directed CAR T-cell Therapies
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
This is a clinical trial to evaluate the safety of combining CAR T-cell therapy with low-dose total body irradiation (LD-TBI) in patients with previously treated large B-cell lymphoma (LBCL) or multiple myeloma (MM). The investigators' hypothesis is that the combination will make the immune system more active in fighting cancer by increasing the display of antigens and activating pathways that lead to cell death, including death receptors like FAS and TRAIL2. This approach is expected to help the CAR T cells grow and last longer, leading to stronger anti-tumor effects and more cancer cell deaths. Participants will receive LDTBI treatment before their CAR T cell therapy and will be followed up for 2 years.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 21 Jul 2026
- Start date
- Nov 2026
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Weill Medical College of Cornell University
- NCT number
- NCT07725406
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From Nov 2026 to the primary completion date, 1 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous total body irradiation
- Prior CAR T-cell therapy
- 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
- History of previous total body irradiation
- History of myelodysplastic syndrome, CCUS, or concurrent active hematological malignancy with bone marrow involvement
- Prior CAR T-cell therapy
Other illness
- Significant cardiovascular impairment (CHF greater than NYHA Class II, uncontrolled hypertension, unstable angina, MI or stroke within 6 months, or cardiac ventricular arrhythmia)
- Active HIV, hepatitis B, or hepatitis C infection
- Active uncontrolled systemic fungal, bacterial, or viral infection
- Active HIV, hepatitis B, or hepatitis C infection
- Active uncontrolled systemic fungal, bacterial, or viral infection
- Active or history of CNS myeloma or leptomeningeal infiltration
Other
- For DLBCL Cohort:
- Clonal cytopenia of uncertain significance (CCUS)
- Decompensated cirrhosis
- Pregnancy
- For MM Cohort:
- Pregnancy
Who the study is looking for
- 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%
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine/NewYork-Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.