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New treatment option for Refractory Non-Hodgkin Lymphoma
Official title CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).
ClinicalTrials.gov ID: NCT05260957
What this study is testing
What is Mosunetuzumab?
Mosunetuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory non-hodgkin lymphoma.
Also referred to as BTCT4465A.
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
- The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.
- 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 to 80
You may be able to join if
- Histologic diagnosis of:
- Diffuse large B cell lymphoma (DLBCL) not otherwise specified. Patients with primary cutaneous DLBCL of leg-type are eligible if the lymphoma...
- Primary mediastinal B cell lymphoma (PMBCL)
- Transformed follicular lymphoma (TFL). An untransformed follicular lymphoma grade 3B will be considered on a case by case basis, since the genetic...
- High grade B cell lymphoma (HGBL), other than B-lymphoblastic lymphoma
You likely can't join if
- Patients with EBV+DLBCL, plasmablastic lymphoma, human herpesvirus-8 (HHV-8) related B cell lymphoproliferative disorders including primary effusion...
- Primary CNS lymphoma or secondary CNS involvement by lymphoma.
- Similarly, patients with conditions that increase the risk of CNS toxicity will be excluded. Such conditions include but not limited to
- active seizure disorder for which an antiepileptic is taken,
- demyelinating diseases like multiple sclerosis
- history of ischemic or hemorrhagic stroke in the last 2 years
See the full eligibility criteria
Who can join
- Histologic diagnosis of:
- Diffuse large B cell lymphoma (DLBCL) not otherwise specified. Patients with primary cutaneous DLBCL of leg-type are eligible if the lymphoma expresses cluster of differentiation 19 (CD19) and if the insurance approves...
- Primary mediastinal B cell lymphoma (PMBCL)
- Transformed follicular lymphoma (TFL). An untransformed follicular lymphoma grade 3B will be considered on a case by case basis, since the genetic signature of grade 3B follicular lymphoma frequently resemble that of...
- High grade B cell lymphoma (HGBL), other than B-lymphoblastic lymphoma
- Mantle Cell lymphoma (MCL)
- Burkitt lymphoma (BL): Although very few reports inform us about the outcome of relapsed/refractory BL, encouraging activity including CRs have been reported with CAR-T and these patients are in need because they do not...
- Additionally, the lymphoma has to be in one of the following status:
- Primary refractory which for the purpose of this study is defined as failure to obtain any response (PR or CR) after at least 3 cycles of anthracycline-based therapy or persistent disease after 6 cycles of...
- Relapsed disease that fails to respond (CR or PR) after at least 2 cycles of a platinum and/or cytarabine-based chemotherapy. For the purpose of this study, appropriate regimens include: rituximab, ifosfamide...
- Relapse after an autologous stem cell transplantation. At least 3 months should have lapsed between autologous stem cell infusion and initiation of pre-CAR-T lymphodepleting chemotherapy due to the risk of prolonged...
- At least one of the lymphoma lesions should be measurable. For the purpose of this study an involved nodal lesion should be at least 1.5 cm in the longest diameter, while extra-nodal lymphoma lesions should have their...
- Lymphoma cells need to be CD19 positive. In case of previous therapy with an anti-CD19 agent (including but not limited to blinatumomab, tafasitamab, loncastuximab tesirine), a new biopsy should be performed to confirm...
- The performance status of the patient as measured by the Eastern Cooperative Oncology Group (ECOG) performance scale should be 0 - 2 (ECOG performance status (PS):0-2).
- Only adult patients will be eligible (patient age \>18 years old). Patients up to 80 years old will be considered to participate in the study assuming they fulfill all the other 7. The creatinine clearance as measured...
- Unless the patient has a known Gilbert syndrome, the total Bilirubin should be less that 1.5 x upper limit of normal (ULN) and both the transaminases (ALT and AST) should be less than 2.5 x ULN. The only exception to...
- The ejection fraction of the left ventricle as it is estimated on the Echocardiogram (preferably) or on the multigated acquisition (MUGA) scan should be at least 45% (LVEF ≥ 45%).
- The oxygen saturation of oxyhemoglobin on room air as measured by pulse oximetry should be at least 94% (O2Sat ≥ 94%). If a technical problem (artifact) is suspected on pulse oximetry, arterial blood gases will be...
- On the day of screening and assuming there will be no other than the protocol therapy, the patient should have at least the following:
- Absolute neutrophil count \>1000/microliter,
- Hg\> 8 grams/ deciliter
- Absolute lymphocyte count \>250/microliter
- Platelet count \>75,000/microliter
- Patient should not have a transfusion of packed red blood cells (PRBCs) or platelets or receive erythropoietin analogues thrombopoietin receptor agonist (Tpo-mimetic), granulocyte colony stimulating factor (G-CSF) or...
- Patient should sign an informed consent and be willing to comply with the anticipated labs and clinic visits and should be willing to be hospitalized and undergo the required invasive procedures as directed by the...
- Female people should have a negative serum pregnancy test, unless they confirm their menopausal status and/or have undergone previous hysterectomy and/or oophorectomy.
- Both men and women with childbearing potential should agree to use effective contraception for the duration of the treatment and for at least 1 year after the last treatment since medications (e.g. cyclophosphamide)...
What rules you out
- Patients with EBV+DLBCL, plasmablastic lymphoma, human herpesvirus-8 (HHV-8) related B cell lymphoproliferative disorders including primary effusion lymphoma, anaplastic lymphoma kinase (ALK)+ LBCL, intravascular large...
- Primary CNS lymphoma or secondary CNS involvement by lymphoma.
- Similarly, patients with conditions that increase the risk of CNS toxicity will be excluded. Such conditions include but not limited to
- active seizure disorder for which an antiepileptic is taken,
- demyelinating diseases like multiple sclerosis
- history of ischemic or hemorrhagic stroke in the last 2 years
- Neurodegenerative disorders like Alzheimer and Parkinson
- Cerebral edema or hydrocephalus of any cause
- Invasive sarcoma or carcinoma in the last 3 years, except from localized basal or squamous cell carcinomas of the skin, or cervical carcinoma in situ. Localized Gleason \<7, prostate-specific antigen (PSA)\<10 prostatic...
- Myocardial infarction or unstable angina or coronary revascularization within 6 months of protocol enrollment is not allowed. Stable angina that requires nitrates for pain relief is not allowed either because of...
- Systemic hypertension that is not controlled with maximum three antihypertensives to a level of \<160/100 precludes enrollment.
- Uncontrolled invasive infection, including fungal pneumonia, fungal sinusitis or fungal encephalitis are not allowed and should be resolved completely before enrollment. Cytomegalovirus (CMV) viremia\>200...
- Patients with history of macrophage activation syndrome (MAS)/hemophagocytic lymphohistiocytosis (HLH) and patients with known or suspected chronic active Epstein Barr Virus infection (CAEBV).
- HIV positivity is allowed as long as the viral load of HIV-1 is less than 200 copies/microliter the last 3 months and the patient continue at least 3 antiretroviral agents during therapy.
- Chronic hepatitis B should have been controlled to hepatitis B virus (HBV) viral load \<200 copies/microliter and patients with chronic hepatitis B or even with just history of exposure to hepatitis B (hepatitis B core...
- Patients with hepatitis C and clearance of the virus with previous therapy are allowed as long as they do not suffer from chronic liver dysfunction. Patients with chronic hepatitis C and normal hepatic function should...
- Autoimmune disorders including rheumatoid arthritis, severe psoriasis, systemic lupus erythematosus, scleroderma with pulmonary involvement, polymyositis, systemic vasculitis and inflammatory bowel disease requiring...
- Other causes of congenital or acquired immunodeficiencies other than common variable immunodeficiency or immunoglobulin A (IgA) deficiency are not allowed.
- External drains including pericardial, pleural, peritoneal, external biliary drains or nephrostomies are not allowed.
- Use of prednisone for any reason should not be \>10 mg/d. All other systemic immunosuppressive agents are not allowed.
- Any biologic agent interfering with the immune system function or cytotoxic chemotherapy are not allowed within 21 days of the first dose of mosunetuzumab. Radiation is not allowed within 14 days of the first...
- Patient should not have anti-human leukocyte antigen (HLA) antibodies that make them refractory to platelets transfusions.
- If patients are on systemic antiplatelet or anticoagulant therapy, this therapy has to be stopped. Patients can continue low dose acetylsalicylic acid (ASA) up to 100 mg/d that will be also stopped when platelets drop...
- Any cardiac disease in addition to left ventricular ejection fraction (LVEF) \<45% that gives symptoms of heart failure (diastolic dysfunction or valvular abnormalities or dysrhythmias) and makes the patient belong to...
- Previous anti-CD19 CAR-T therapy is not allowed.
- Uncontrolled Psychosis or cognitive impairment that makes the patient unable to make informed decisions preclude participation.
- Previous solid organ transplantation precludes participation.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, 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.