MedTrace Logo

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

NCT07376642 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Interventions

DRUG

IMV101 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.

Sponsors & Collaborators

  • Suzhou Immunofoco Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-29
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07376642 on ClinicalTrials.gov