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New treatment option for Non Hodgkin Lymphoma
Official title IOMAB-CAR-T Followed by CAR-T Cell Therapy in R/R DLBCL
ClinicalTrials.gov ID: NCT06768905
What this study is testing
What is Iomab-B?
Iomab-B is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non hodgkin lymphoma.
Also referred to as Iomab-ACT, 131I-Apamistamab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with diffuse large B-cell lymphoma (de novo or DLBCL transformed from an indolent lymphoma (follicular lymphoma, chronic lymphocytic...
- Defined as relapsed or refractory DLBCL or high-grade B-cell lymphoma (HGBL) following at least one or more prior chemoimmunotherapy regimen (with at...
- 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.
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.