IOMAB-CAR-T Followed by CAR-T Cell Therapy in R/R DLBCL (NCT06768905) | Clinical Trial Compass
RecruitingPhase 1/2
IOMAB-CAR-T Followed by CAR-T Cell Therapy in R/R DLBCL
United States30 participantsStarted 2025-04-25
Plain-language summary
This study is being done to determine the safety, efficacy and tolerability of a single 50 mCi dose of 131I-Apamistamab given prior to FDA approved (commercially available) infusion in patients with Relapsed or refractory (R/R) non-Hodgkin lymphoma.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients with diffuse large B-cell lymphoma (de novo or DLBCL transformed from an indolent lymphoma (follicular lymphoma, chronic lymphocytic leukemia \[Richter syndrome\]) or high-grade B-cell lymphoma (HGBL): ("DLBCL patients")
✓. Age ≥ 18 years of age
✓. Creatinine clearance ≥50 mL/min as calculated by the Cockroft-Gault formula.
✓. Total bilirubin ≤1.5x upper limit of normal , AST and ALT ≤3x upper limit of normal (ULN), unless liver dysfunction is thought to be related to underlying malignancy or secondary to Gilbert's disease in which case the direct bilirubin should be ≤3.0 mg/dL, and AST and ALT ≤5x ULN.
✓. Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air or per institutional guidelines.
✓. Thyroid function tests (TSH, FT4) ≤2x upper limit of normal (ULN)
✓. Adequate bone marrow function meeting the following criteria as defined below, without requiring blood product or granulocyte-colony stimulating factor support in the 7 days prior to screening and start of 131I-Apamistamab treatment.
✓. Absolute neutrophil count ≥1.0k/µL,
Exclusion criteria
✕. Pregnant or lactating patients.
✕. Impaired cardiac function (LVEF \<40%) as assessed by echocardiogram or MUGA scan.
✕. Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T-cell suppressive therapy are ineligible.
What they're measuring
1
Dose-limiting toxicity (safety) -Part A (safety run-in)
Timeframe: Start of treatment up to 30 days post CAR T-cell infusion
2
Complete response (efficacy) -Part B (Cohort expansion)
Timeframe: Screening visit to Day 100 visit
Trial details
NCT IDNCT06768905
SponsorUniversity of Texas Southwestern Medical Center
✕. Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible.
✕. Patients with the following cardiac conditions will be excluded:
✕. New York Heart Association (NYHA) stage III or IV congestive heart failure
✕. Myocardial infarction ≤6 months prior to enrollment
✕. Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.