OncoMatch/Clinical Trials/NCT07376642
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
Is NCT07376642 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies IMV101 treatment for relapsed/refractory b-cell non-hodgkin lymphoma.
Treatment: IMV101 treatment — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positivity (positive)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-CD20 monoclonal antibody
documented prior exposure to both an anti-CD20 monoclonal antibody (unless CD20-negative)
Must have received: anthracycline-based chemotherapy
documented prior exposure to...an anthracycline-based chemotherapy regimen
Cannot have received: autologous stem cell transplantation
Exception: allowed if relapse occurred after ASCT; excluded if ASCT within 12 weeks prior to enrollment
Received autologous stem cell transplantation (ASCT) within 12 weeks prior to enrollment
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: relapse ≥2 years after allo-HSCT allowed if no ongoing immunosuppressive therapy; otherwise excluded
any prior allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Cannot have received: chemotherapy
Exception: last dose must be ≥28 days or 5 half-lives (whichever is shorter) before first IMV101 dose
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
Cannot have received: targeted therapy
Exception: last dose must be ≥28 days or 5 half-lives (whichever is shorter) before first IMV101 dose
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
Cannot have received: biologic therapy
Exception: last dose must be ≥28 days or 5 half-lives (whichever is shorter) before first IMV101 dose
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
Cannot have received: endocrine therapy
Exception: last dose must be ≥28 days or 5 half-lives (whichever is shorter) before first IMV101 dose
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
Cannot have received: immunotherapy
Exception: last dose must be ≥28 days or 5 half-lives (whichever is shorter) before first IMV101 dose
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
Cannot have received: traditional Chinese medicine with approved antineoplastic indications
Exception: last dose must be ≥2 weeks before IMV101 administration
traditional Chinese medicine with approved antineoplastic indications within 2 weeks prior to IMV101 administration
Lab requirements
Blood counts
Hematological criteria (in absence of intensive transfusion [≥2 times within 1 week], platelet administration, or growth factor support [except recombinant erythropoietin] within 7 days prior to testing)
Kidney function
Serum creatinine ≤1.5×ULN; if >1.5×ULN, creatinine clearance >50 mL/min (Cockcroft-Gault); urine protein dipstick ≤1+ (if ≥2+, 24h urine protein <1 g/24h)
Liver function
ALT and AST ≤2.5×ULN, and total bilirubin ≤2×ULN (except Gilbert's syndrome); if hepatic involvement by lymphoma, ALT and AST <5×ULN
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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