Non Hodgkin LymphomaPhase 1/2NCT06768905
IOMAB-CAR-T Followed by CAR-T Cell Therapy in R/R DLBCL
A Phase 1/2 study testing Iomab-B and CAR-T cell in people with Non Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
- What is being tested?
- Iomab-B and CAR-T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2025to May 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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")
- 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.
- 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.
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- 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,
- Platelets ≥50k/µL,
- Hemoglobin ≥8g/dL.
- Performance status: ECOG performance status 0-2.
- All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, and/or abstinence) prior to study entry, and for the duration of study treatment, and for 30 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- 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).
- Ability to understand and the willingness to sign a written informed consent.
- For patients undergoing bridging therapy after leukapheresis and prior to 131I-Apamistamab infusion a repeat PET or CT scan will be performed 10-14 days prior to the 131I-Apamistamab infusion. They will also be required to meet inclusion criteria number 1 and 7 above within 10-14 days prior to the planned infusion of 131I-Apamistamab. This will be considered eligibility Screening 2 and will be approved by the Sponsor-Investigator.
Who cannot join
- 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.
- 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
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- 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.
- Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions:
- Patients who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HbsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HbsAg (anti-HBs) are not excluded.
- Patients who have antibodies to HCV or who have hepatitis B core antibody, with undetectable viremia by PCR, and with adequate organ function as defined in the protocol, are not excluded.
- Patients with uncontrolled systemic fungal, bacterial, viral, or other infections are ineligible.
- Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.
- Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.
- Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.
- Patients with circulating human anti-mouse antibodies (HAMA) to BC8. The results of HAMA testing will need to be available prior to 131I-Apamistamab infusion.
- Patients with prior history of treatment with radiopharmaceuticals for lymphoma treatment indication.
- Patients with QTcF >470mSec on EKG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Silviya Meletath, 214-648-7097, silviya.meletath@utsouthwestern.edu
About this study
Official title: IOMAB-ACT: A Phase Ib/II Multi-institutional Study of 131 I-Apamistamab Followed by CD19-Targeted CAR-T Cell Therapy for Patients With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
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.
Read the detailed description
This is an open-label single-cohort multi-institutional study of 131I-Apamistamab followed by CAR-T cell therapy for patients with (R/R) DLBCL. Patients will receive a 50 mCi single planned 131I-Apamistamab dose prior to CAR-T cell infusion for lymphodepleting conditioning. There will be a 6-patient safety run-in to assess safety.
- Being tested
- Iomab-B, CAR-T cell
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iomab-BDrug
Also called Iomab-ACT, 131I-Apamistamab
single 50 mCi dose of 131I-Apamistamab given prior to CAR-T cell infusion.
CAR-T cellDrug
Also called CAR-T cell therapy
CAR-T cell therapy
| Study group | Role | What they receive |
|---|---|---|
| Part A (Safety run-in) | Experimental | 131I-Apamistamab dose will be given 5-7 days prior to a single infusion of CD-19 CAR-T cell therapy Receives: Drug: Iomab-B; Drug: CAR-T cell |
| Part B (cohort expansion) | Experimental | 131I-Apamistamab dose will be given 5-7 days prior to a single infusion of CAR-T cell therapy Receives: Drug: Iomab-B; Drug: CAR-T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (safety) -Part A (safety run-in)
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.
Measured: Start of treatment up to 30 days post CAR T-cell infusion
Complete response (efficacy) -Part B (Cohort expansion)
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
Measured: Screening visit to Day 100 visit
Secondary outcomes (2)
Severity of cytokine release syndrome (CRS)
Incidence and severity of CRS (all grades, as well as grade ≥3 CRS) following 131I-Apamistamab and CAR-T cell infusion in patients with R/R DLBCL will be collected.
The number and percent of subjects developing versus not developing grade ≥3 neurologic toxicity following 131I-Apamistamab and CAR-T cell infusions will be summarized using the EAS. Efficacy Analysis Set (EAS): is defined as all patients in the SAS who have at least one post-baseline response assessment or discontinued the study due to disease progression (including death caused by disease progression).
Measured: within 100 days of CAR T-cell infusion
Severity of immune effector cell-associated neurotoxicity (ICANS)
Neurologic toxicities (ICANS) will be graded by The American Society for Blood and Marrow Transplantation (ASBMT) Consensus Grading criteria for ICANS. The number and percent of subjects developing versus not developing grade ≥3 neurologic toxicity following 131I-Apamistamab and CAR-T cell infusions will be summarized using the EAS. Efficacy Analysis Set (EAS): is defined as all patients in the SAS who have at least one post-baseline response assessment or discontinued the study due to disease progression (including death caused by disease progression).
Measured: within 100 days of CAR T-cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start25 Apr 2025
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Actinium Pharmaceuticals
- Responsible party
- Principal investigator, Farrukh Awan, University of Texas Southwestern Medical Center
- Investigators
- Farrukh Awan, MD, MS, MBA, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768905
- Sponsor's protocol ID
- STU-2024-1091; SCCC-03424
- Status last verified
- May 2026
- First submitted
- 6 Jan 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IOMAB-ACT: A Phase Ib/II Multi-institutional Study of 131 I-Apamistamab Followed by CD19-Targeted CAR-T Cell Therapy for Patients With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT06768905
- Acronym / sponsor ID
- STU-2024-1091; SCCC-03424
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Actinium Pharmaceuticals
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label single-cohort multi-institutional study of 131I-Apamistamab followed by CAR-T cell therapy for patients with (R/R) DLBCL. Patients will receive a 50 mCi single planned 131I-Apamistamab dose prior to CAR-T cell infusion for lymphodepleting conditioning. There will be a 6-patient safety run-in to assess safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A (Safety run-in) | Experimental | Drug: Iomab-B, Drug: CAR-T cell131I-Apamistamab dose will be given 5-7 days prior to a single infusion of CD-19 CAR-T cell therapy |
| Part B (cohort expansion) | Experimental | Drug: Iomab-B, Drug: CAR-T cell131I-Apamistamab dose will be given 5-7 days prior to a single infusion of CAR-T cell therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
- Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible.
- Patients with the following cardiac conditions will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iomab-BAlso: Iomab-ACT, 131I-Apamistamabsingle 50 mCi dose of 131I-Apamistamab given prior to CAR-T cell infusion. | Drug | Part A (Safety run-in), Part B (cohort expansion) |
| CAR-T cellAlso: CAR-T cell therapyCAR-T cell therapy | Drug | Part A (Safety run-in), Part B (cohort expansion) |
Primary outcome
Dose-limiting toxicity (safety) -Part A (safety run-in)
Time frame: 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)
Time frame: 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
2 secondary outcomes
Severity of cytokine release syndrome (CRS)
Time frame: within 100 days of CAR T-cell infusion
Severity of immune effector cell-associated neurotoxicity (ICANS)
Time frame: within 100 days of CAR T-cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Farrukh Awan, MD, MS, MBA principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Iomab-B and CAR-T cell in people with Non Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farrukh Awan, MD, MS, MBA (817-676-9670, farrukh.awan@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (safety) -Part A (safety run-in) (time frame: Start of treatment up to 30 days post CAR T-cell infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.