RecruitingEarly Phase 1NCT07376642

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


Sponsor

Suzhou Immunofoco Biotechnology Co., Ltd

Enrollment

30 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests the safety and early effectiveness of a new drug called IMV101 — given alone or with other treatments — in adults with relapsed or treatment-resistant B-cell non-Hodgkin lymphoma, a type of blood cancer that has stopped responding to prior therapies. **You may be eligible if...** - You are 18 or older with confirmed B-cell non-Hodgkin lymphoma (such as DLBCL, follicular lymphoma, or mantle cell lymphoma) that has returned or is no longer responding to treatment - You have received at least two prior treatment regimens, or relapsed after a stem cell transplant - Your cancer tests positive for the CD19 protein - You have at least one measurable tumor lesion - Your heart, liver, kidney, and blood counts are within acceptable ranges **You may NOT be eligible if...** - Your lymphoma has spread to the brain or spinal fluid - You have recently had an organ transplant or stem cell transplant - You are pregnant or breastfeeding - You have active HIV, hepatitis B, hepatitis C, or other serious infections - You have severe heart disease or uncontrolled high blood pressure - You have used immunosuppressive medications recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIMV101 treatment

IMV101 Dose Escalation Scheme: Dose Level DL-1,Dose 1e7、Dose Level DL1,Dose 3e7、Dose Level DL2 Dose 1e8、Dose Level DL3 Dose 3e8、Dose Level DL4 Dose 1e9;Accelerated Titration: The 3×10⁷ TU/subject dose cohort will enroll one subject. If this subject experiences a Grade ≥2 adverse event related to IMV101, the cohort will transition to the standard "3+3" design by enrolling two additional subjects for safety and tolerability assessment.


Locations(4)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Beijing GoBroad Boren Hospital

Beijing, Beijing Municipality, China

Zhengzhou Yihe Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07376642


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