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 | Recruiting Early Phase 1 DMC

• 1 other identifier: IMV101-CT01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• DLTs/RP2D/Efficacy endpoint

  To observe the incidence of dose-limiting toxicities (DLTs) within 28 days following IMV101 administration.To determine the Recommended Phase II Dose (RP2D) of IMV101.Efficacy endpoints: Time to response (TTR), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Objective response rate includes stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), assessed according to the Lugano 2014 classification for lymphoma efficacy assessment (Cheson, 2014).

  For dose-limiting toxicity (DLT) assessment: From study drug administration through 28 days after dosing.The Recommended Phase 2 Dose (RP2D) will be evaluated and confirmed by the Study Monitoring Committee (SMC) after discussion.

Secondary Outcomes (6)

• Treatment-related adverse events (TRAEs)

  From first dose of IMV101 until disease progression, initiation of other anti-cancer therapy, or death (whichever occurs first); maximum 15 years of assessment.

• Assessment of pharmacokinetic (about Cmax)

  From first dose of IMV101 until disease progression, initiation of other anti-cancer therapy, or death (whichever occurs first);maximum 96 weeks of assessment for PK and PD

• Assessment of pharmacokinetic (about Tmax)

  From first dose of IMV101 until disease progression, initiation of other anti-cancer therapy, or death (whichever occurs first);maximum 96 weeks of assessment for PK and PD

• Assessment of pharmacokinetic (about AUC0-28d)

  From first dose of IMV101 to 28 days after IMV101 administration

• Assessment of pharmacokinetic (about AUC0-90d)

  From first dose of IMV101 to 90 days after IMV101 administration

Other Outcomes (2)

• To evaluate the immunogenicity of IMV101 injection

  From first dose of IMV101 until disease progression, initiation of other anti-cancer therapy, or death (whichever occurs first); maximum 15 years of assessment.

• RCL testing

  From first dose of IMV101 until disease progression, initiation of other anti-cancer therapy, or death (whichever occurs first); maximum 15 years of assessment.

Study Arms (1)

IMV101 treatment group

EXPERIMENTAL

IMV101 single infusion

Drug: IMV101 treatment

Interventions

IMV101 treatment DRUG

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.

IMV101 treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL), and mantle cell lymphoma (MCL), among others.
• CD19 positivity confirmed by pathology or flow cytometry analysis (subjects 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 CD20-negative) and an anthracycline-based chemotherapy regimen.
• 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.
• ． According to the Lugano lymphoma response criteria (Cheson et al, 2014), at least one measurable lesion must be present, meeting one of the following conditions:
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• 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.
• ． Life expectancy ≥ 12 weeks. 7． ECOG performance status score of 0 or 1. 8． Subjects must have adequate organ and marrow function. Laboratory screening must meet all of the following criteria, with all values falling within the specified ranges without ongoing supportive care. If any laboratory result is outside these limits, one repeat test is permitted within one week. If the repeat result still does not meet the criteria, the subject fails screening and is ineligible for enrollment:
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• 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 testing).
• Hepatic Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤2.5×ULN, and total bilirubin ≤2×ULN (except in subjects with Gilbert's syndrome); for those with documented hepatic involvement by lymphoma, ALT and AST must be \<5×ULN.

You may not qualify if:

• ．Reproductive Status: Females of childbearing potential or male subjects with female partners of childbearing potential must be willing to use highly effective medically approved contraception from the time of informed consent until 12 months after IMV101 administration. Acceptable methods include intrauterine devices or condoms (childbearing potential includes premenopausal women and women within 24 months of menopause).
• ． Subjects must provide signed and dated written informed consent. 12．Subjects must demonstrate willingness and ability to comply with the prescribed treatment plan, laboratory tests, follow-up visits, and other study requirements.
• Pregnant or lactating women.
• Subjects 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.
• Subjects with lymphoma infiltration of the atria or ventricles.
• Subjects 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 bronchodilator intervention), immunodeficiency, or other medical conditions. Exceptions include type 1 diabetes; dermatological conditions not requiring systemic therapy (e.g., vitiligo, psoriasis); alopecia; hypothyroidism managed with hormone replacement therapy only; childhood asthma that has completely resolved with no intervention required in adulthood; or other conditions not expected to recur in the absence of an external trigger.
• 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 immunosuppressive agents (excluding topical therapy) within 12 weeks after IMV101 administration;
• Participation in another interventional clinical trial with receipt of any investigational product within 1 month prior to the planned administration of the study drug.
• Prior to IMV101 administration, subjects who have received any of the following antineoplastic therapies: chemotherapy, targeted therapy, biologic therapy, endocrine therapy, or immunotherapy, where the last dose was administered within 28 days or 5 half-lives (whichever is shorter) before the first IMV101 dose in this study; or have received traditional Chinese medicine with approved antineoplastic indications within 2 weeks prior to IMV101 administration.

Sponsors & Collaborators

• Suzhou Immunofoco Biotechnology Co., Ltd: lead

Study Sites (4)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100020, China

NOT YET RECRUITING

Beijing GoBroad Boren Hospital

Beijing, Beijing Municipality, 100070, China

NOT YET RECRUITING

Zhengzhou Yihe Hospital

Zhengzhou, Henan, 450047, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Hongyan Tong, Doctor of Medicine

CONTACT

0571-87235589; hongyantong@aliyun.com

Chunmei Yang, Doctor of Medicine

CONTACT

0571-87235589; yangchunmei2008@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This Phase I/IIa study is an open-label, single-center trial incorporating dose-escalation and dose-expansion cohorts to assess the safety, tolerability, and preliminary antitumor efficacy of IMV101 in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma-including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma (HGBCL)-as well as mantle cell lymphoma (MCL).

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 29, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)