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IOMAB-CAR-T Followed by CAR-T Cell Therapy for Relapsed/Refractory DLBCL

This study is testing a new approach for people with diffuse large B-cell lymphoma (DLBCL) that has come back or not responded to previous treatments. It combines a single dose of Iomab-B, a type of drug, with CAR-T cell therapy, which uses your own specially modified immune cells to fight cancer. Researchers want to see how safe and effective this combination is. You might be able to join if you are 18 or older and have DLBCL that is relapsed or refractory after at least one prior chemoimmunotherapy. The study will look at how safe the treatment is and how many people have a complete response (meaning their cancer goes away). The current recruitment status is unclear, and the study plans to enroll 30 participants.

Study design
This is an open-label, single-group study, meaning everyone receives the same treatment and both you and the study team know what treatment is being given. There will be a safety run-in with 6 patients.
What's involved
You will receive a single dose of Iomab-B before your CAR-T cell infusion. Safety will be monitored from the start of treatment up to 30 days after CAR-T cell infusion, and complete response will be measured from screening to Day 100.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 30 days after CAR-T cell infusion, and your response to treatment will be assessed up to Day 100.

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

NCT06768905

IOMAB-CAR-T Followed by CAR-T Cell Therapy in R/R DLBCL

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~30 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Iomab-BCAR-T cell

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity (safety) -Part A (safety run-in)
Measured over Start of treatment up to 30 days post CAR T-cell infusion
+1 more outcome measured

Conditions

Non Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma

Explore related trials

Diffuse Large B-Cell LymphomaHigh Grade B-Cell Lymphoma

NCT06768905

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Texas Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Farrukh Awan, MD, MS, MBA · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Farrukh Awan, MD, MS, MBA
[email protected]
817-676-9670
Email the study team

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Eligibility criteria

Inclusion

Defined as relapsed or refractory DLBCL or high-grade B-cell lymphoma (HGBL) following at least one or more prior chemoimmunotherapy regimen (with at least one course including an anthracycline and CD20-directed therapy) following diagnosis of de novo DLBCL/HGBL or DLBCL arising from indolent lymphoma and requiring further treatment and deemed to be candidates for standard of care CAR-T therapy. This includes patients with primary refractory disease (failure to achieve complete response (CR) to first-line therapy), relapsed disease within 12 months of first line chemoimmunotherapy or relapsed/refractory disease after 2 or more prior lines of systemic therapy.
Relapsed or refractory disease must be confirmed with a repeat biopsy within the last 12 months. 2. Age ≥ 18 years of age 3. Creatinine clearance ≥50 mL/min as calculated by the Cockroft-Gault formula. 4. 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. 5. Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air or per institutional guidelines. 6. Thyroid function tests (TSH, FT4) ≤2x upper limit of normal (ULN) 7. 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.
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 10. Ability to understand and the willingness to sign a written informed consent.

What this trial measures

  • Dose-limiting toxicity (safety) -Part A (safety run-in)Start of treatment up to 30 days post CAR T-cell infusion

    The number and percentage of patients with DLTs will be summarized for Part A using the DLT Analysis Set. The data analysis set will include all patients in Part A who received study medication and either experienced a DLT or completed at least 75% of the DLT period. Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0.

  • Complete response (efficacy) -Part B (Cohort expansion)Screening visit to Day 100 visit

    Measurement of effect (response and progression) will be conducted using a PET/CT scan which will report the Lugano criteria for response at screening 1 and 2 (if PET available), Day 30 +7 days, and Day 100 +/-7 days