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Tests treatment safety and results for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Official title A Phase I/IIa, Open-label, Single-center, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IMV101 as a Single Agent in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT07376642
What this study is testing
What is IMV101 treatment?
IMV101 treatment is an investigational medicine, being studied as a potential treatment for relapsed/refractory b-cell non-hodgkin lymphoma.
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
- A phase I/IIa, open-label, single-center, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and preliminary efficacy of IMV101 as a single agent in subjects with relapsed/refractory B-cell non-Hodgkin Phase I:To observe and evaluate the safety and tolerability of IMV101 in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Phase IIa:To determine the Recommended Phase II Dose (RP2D) based on integrated safety and efficacy data following IMV101 treatment.
- Phase 1: an early, usually small safety study
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
- Aged 18 years or older, any sex.
- Previously histologically or cytologically confirmed relapsed/refractory B-cell non-Hodgkin's lymphoma, including the following WHO-defined types...
- CD19 positivity confirmed by pathology or flow cytometry analysis (people with prior exposure to CD19-targeted therapies must undergo repeat biopsy...
- Relapsed/refractory B-cell non-Hodgkin lymphoma meeting at least one of the following criteria:
- Disease progression after at least two prior lines of systemic therapy (including relapse, treatment failure, or disease progression), with...
You likely can't join if
- . Exceptions include alopecia, vitiligo, and other toxicities considered by the investigator to pose no safety risk to the subject. 10．Reproductive...
- Pregnant or lactating women.
- people with active central nervous system (CNS) involvement or intestinal parenchymal involvement by B-cell non-Hodgkin lymphoma.
- Presence of lymphoma cells in cerebrospinal fluid (CSF), brain metastases, or a history of CNS lymphoma, primary CNS lymphoma, or previously detected...
- people with lymphoma infiltration of the atria or ventricles.
- people who have received or require any of the following treatments/therapies:
See the full eligibility criteria
Who can join
- Aged 18 years or older, any sex.
- Previously histologically or cytologically confirmed relapsed/refractory B-cell non-Hodgkin's lymphoma, including the following WHO-defined types: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), primary...
- CD19 positivity confirmed by pathology or flow cytometry analysis (people with prior exposure to CD19-targeted therapies must undergo repeat biopsy prior to enrollment to reconfirm CD19-positive status).
- Relapsed/refractory B-cell non-Hodgkin lymphoma meeting at least one of the following criteria:
- Disease progression after at least two prior lines of systemic therapy (including relapse, treatment failure, or disease progression), with documented prior exposure to both an anti-CD20 monoclonal antibody (unless...
- Relapsed disease following autologous hematopoietic stem cell transplantation; or relapse occurring ≥2 years after allogeneic hematopoietic stem cell transplantation, in the absence of ongoing immunosuppressive therapy.
- Primary refractory disease, defined as stable disease or disease progression as best response after at least two cycles of initial anti-CD20-based immunochemotherapy. 5． According to the Lugano lymphoma response...
- A nodal lesion with a long axis \>15 mm (short axis may be used if measurable).
- An extranodal lesion with both long and short axes \>10 mm. Lesions previously irradiated will only be considered measurable if documented progression has occurred after radiation therapy. 6． Life expectancy ≥ 12 weeks...
- Hematological criteria (in the absence of intensive transfusion [≥2 times within 1 week], platelet administration, or growth factor support [with the exception of recombinant erythropoietin] within 7 days prior to...
- Hepatic Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤2.5×ULN, and total bilirubin ≤2×ULN (except in people with Gilbert's syndrome); for those with documented hepatic...
- Renal Function: Serum creatinine ≤1.5×ULN; if serum creatinine exceeds this threshold, creatinine clearance must be \>50 mL/min (calculated using the Cockcroft-Gault formula). Urine protein dipstick must be ≤1+; if...
What rules you out
- . Exceptions include alopecia, vitiligo, and other toxicities considered by the investigator to pose no safety risk to the subject. 10．Reproductive Status: Females of childbearing potential or male people with female...
- Pregnant or lactating women.
- people with active central nervous system (CNS) involvement or intestinal parenchymal involvement by B-cell non-Hodgkin lymphoma.
- Presence of lymphoma cells in cerebrospinal fluid (CSF), brain metastases, or a history of CNS lymphoma, primary CNS lymphoma, or previously detected lymphoma cells in CSF or brain metastases.
- people with lymphoma infiltration of the atria or ventricles.
- people who have received or require any of the following treatments/therapies:
- Acute or chronic graft-versus-host disease (GVHD) requiring systemic treatment within 4 weeks prior to enrollment.
- Requiring immunosuppressive treatment during the study period due to autoimmune diseases (including but not limited to Crohn's disease, rheumatoid arthritis, psoriasis, systemic lupus erythematosus, or asthma requiring...
- Received autologous stem cell transplantation (ASCT) within 12 weeks prior to enrollment, or any prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Administration of live attenuated vaccines within 4 weeks before the planned IMV101 administration or planned receipt of such vaccines during the 12-week study period.
- Systemic corticosteroid use at a dose exceeding 15 mg/day prednisone equivalent for more than 3 days within 2 weeks prior to IMV101 administration, with the exception of inhaled corticosteroids.
- Any comorbidities that, in the Investigator's judgment, are expected to require systemic corticosteroid therapy (except for physiological replacement therapy with ≤12 mg/m²/day hydrocortisone or equivalent) or other...
- Participation in another treatment clinical trial with receipt of any investigational product within 1 month prior to the planned administration of the study drug.
- Prior to IMV101 administration, people who have received any of the following antineoplastic therapies: chemotherapy, targeted therapy, biologic therapy, endocrine therapy, or immunotherapy, where the last dose was...
- Major surgery within 2 weeks prior to enrollment in this study, or planned surgery during the waiting period for IMV101 administration or within 12 weeks after treatment (excluding scheduled procedures under local...
- people with a history of concurrent or previous other malignancies are excluded, except for the following conditions:
- Adequately treated basal cell or squamous cell carcinoma (requiring sufficient wound healing prior to enrollment);
- Carcinoma in situ of the cervix or breast, treated with curative intent and without evidence of recurrence for at least 3 years prior to the study;
- Primary tumor that has been completely resected and in complete remission for ≥5 years.
- Seropositivity for human immunodeficiency virus (HIV); active hepatitis B virus (HBV) infection (HBV-DNA \>10³IU/mL); acute or chronic active hepatitis C (anti-HCV positive); confirmed syphilis seropositivity; active...
- Active or clinically uncontrolled severe infection; or people with bacterial, fungal, or viral infections requiring intravenous antibiotic therapy who, in the judgment of the Investigator, are unsuitable for study...
- Uncontrolled pleural effusion, pericardial effusion, or ascites present prior to participation in this study.
- Oxygen saturation≤95% while on nasal cannula oxygen.
- Presence of other significant pulmonary diseases that may limit participation in this study, such as pulmonary embolism, chronic obstructive pulmonary disease, symptomatic or poorly controlled interstitial lung disease...
- Known history or current presence of hepatic encephalopathy requiring treatment; people with current or historical central nervous system disorders, including but not limited to seizures, cerebral ischemia/hemorrhage...
- Poorly controlled hypertension as determined by the Investigator (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure \>100 mmHg despite standardized antihypertensive therapy); or hypotension...
- History of any of the following cardiac symptoms or diseases within 6 months prior to IMV101 administration:
- Left ventricular ejection fraction (LVEF) \< 50%;
- Myocardial infarction within 1 year; or unstable angina; or history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); or use of a cardiac pacemaker;
- QTc interval \> 450 ms (male) or \> 470 ms (female) on resting electrocardiogram (ECG)
- Clinically significant abnormalities on resting ECG (e.g., abnormalities in heart rate, conduction, or morphology) or complete left bundle branch block, third-degree atrioventricular block, or PR interval \> 250 ms.
- History of other severe allergic reactions, such as anaphylaxis.
- people with severe psychiatric disorders.
- people with newly developed arrhythmias, including but not limited to those not adequately controlled by antiarrhythmic medication.
- History of solid organ transplantation.
- people who, in the opinion of the Investigator, are unable or unwilling to comply with the requirements of the study protocol.
- Presence of any other concurrent severe and/or uncontrolled medical condition that, based on the Investigator's judgment, renders the subject unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Zhengzhou, Henan, China
- Hangzhou, Zhejiang, China
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 Beijing, Beijing Municipality, China; Zhengzhou, Henan, China; Hangzhou, Zhejiang, China. 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.