Actively Recruiting
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
Led by Suzhou Immunofoco Biotechnology Co., Ltd · Updated on 2026-03-30
30
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. To evaluate the preliminary antitumor efficacy of IMV101. Secondary Study Objectives:To evaluate other safety parameters following IMV101 treatment. To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles following administration of IMV101. Exploratory Objective:To evaluate biomarkers change pre- and post-IMV101 administration and their correlation with efficacy and safety. To perform long-term follow-up for immunogenicity analysis, viral shedding studies, tumor multi-omics research, lentiviral integration sites, and replication-competent lentivirus (RCL), among others.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, any sex.
- Histologically or cytologically confirmed relapsed/refractory B-cell non-Hodgkin lymphoma, including DLBCL, FL, PMBCL, HGBCL, MCL, and others.
- CD19 positive status confirmed by pathology or flow cytometry; repeat biopsy required if previously treated with CD19-targeted therapies.
- Relapsed/refractory disease meeting at least one of: progression after two prior systemic therapies including anti-CD20 and anthracycline regimens; relapse after autologous or allogeneic stem cell transplant under specified conditions; or primary refractory disease after initial anti-CD20 immunochemotherapy.
- At least one measurable lesion per Lugano lymphoma response criteria.
- Life expectancy of at least 12 weeks.
- ECOG performance status 0 or 1.
- Adequate organ and marrow function based on specified lab criteria.
- Resolution of prior therapy toxicities to Grade 0-1 or acceptable exceptions.
- Willingness to use effective contraception during and for 12 months after treatment if of childbearing potential.
- Signed informed consent.
- Ability and willingness to follow treatment and study procedures.
You will not qualify if you...
- Pregnant or lactating women.
- Active CNS or intestinal lymphoma involvement.
- Lymphoma cells in cerebrospinal fluid, brain metastases, history of CNS lymphoma.
- Lymphoma infiltration of heart atria or ventricles.
- Acute or chronic graft-versus-host disease requiring recent systemic treatment.
- Need for immunosuppressive therapy during study for autoimmune or other conditions, with specific exceptions.
- Recent autologous stem cell transplant within 12 weeks or any prior allogeneic transplant.
- Recent live attenuated vaccines before or during the study.
- High-dose systemic corticosteroids shortly before treatment.
- Comorbidities requiring systemic corticosteroids or immunosuppressants within 12 weeks post treatment.
- Participation in another interventional trial with recent investigational drug use.
- Recent chemotherapy, targeted therapy, biologics, endocrine therapy, immunotherapy, or certain traditional medicines before study drug.
- Recent major surgery or planned surgery interfering with study treatment.
- History of other malignancies except adequately treated basal/squamous cell carcinoma, carcinoma in situ treated with curative intent, or tumors in remission for 5 years.
- Positive tests for HIV, active hepatitis B or C, syphilis, active EBV or CMV infection, or recent COVID-19 infection without resolution.
- Active or uncontrolled severe infections or infections requiring intravenous antibiotics.
- Uncontrolled pleural, pericardial effusions, or ascites.
- Oxygen saturation below 95% on nasal oxygen.
- Significant pulmonary diseases or abnormal pulmonary function.
- History or presence of CNS disorders requiring treatment.
- Poorly controlled hypertension, hypotension needing vasopressors, or poorly controlled diabetes.
- Recent serious cardiac conditions or abnormal ECG findings.
- History of severe allergic reactions.
- Severe psychiatric disorders.
- Newly developed uncontrolled arrhythmias.
- History of solid organ transplantation.
- Inability or unwillingness to comply with study protocol.
- Other severe uncontrolled medical conditions per Investigator judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100020
Not Yet Recruiting
2
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality, China, 100070
Not Yet Recruiting
3
Zhengzhou Yihe Hospital
Zhengzhou, Henan, China, 450047
Actively Recruiting
4
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
H
Hongyan Tong, Doctor of Medicine
CONTACT
C
Chunmei Yang, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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