Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.85 |
| Relapsed or Refractory Multiple Myeloma (MM) | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axicabtagene Ciloleucel | Other | — | UNRESOLVED |
| Ciltacabtagene Autoleucel | Other | — | UNRESOLVED |
| Lisocabtagene Maraleucel | Other | — | UNRESOLVED |
| Low-Dose Total Body Irradiation | Radiation | — | UNRESOLVED |
| Lymphodepleting chemotherapy: Bendamustine | Drug | — | UNRESOLVED |
| Lymphodepleting chemotherapy: Cyclophosphamide | Drug | — | UNRESOLVED |
| Lymphodepleting chemotherapy: Fludarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- Part 1: LBCL: Dose Level -1 (0.5 Gy)
- description
- Participants with relapsed/refractory LBCL receive lymphodepletion followed by LD-TBI 0.5 Gy on Day 0, ≥4 hours before infusion of commercial CD19-directed CAR T-cell therapy. Used if de-escalation from Dose Level 0 is required due to dose-limiting toxicity.
- interventionNames
- Drug: Lymphodepleting chemotherapy: Cyclophosphamide
- Drug: Lymphodepleting chemotherapy: Fludarabine
- Other: Lisocabtagene Maraleucel
- Other: Axicabtagene Ciloleucel
- Radiation: Low-Dose Total Body Irradiation
- type
- EXPERIMENTAL
- label
- Part 1: LBCL: Dose Level 0 (1.0 Gy, Starting Dose)
- description
- Participants with relapsed/refractory LBCL receive lymphodepletion followed by LD-TBI 1.0 Gy (starting dose) on Day 0, ≥4 hours before infusion of commercial CD19-directed CAR T-cell therapy.
- interventionNames
- Drug: Lymphodepleting chemotherapy: Cyclophosphamide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available