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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.