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IMV101 treatment

Phase 1

Relapsed/Refractory B-cell Non-Hodgkin Lymphoma | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Mar 30, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07376642A 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 LymphomaEARLY_PHASE1 RECRUITING 30 — — Dec 29, 2025Dec 31, 2027Mar 30, 20264 China
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Study Endpoints
Primary Endpoints
DLTs/RP2D/Efficacy endpoint
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.

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).

Secondary Endpoints
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IMV101 treatment groupEXPERIMENTALIMV101 single infusion
Interventions
NameTypeDescription
IMV101 treatmentDRUGIMV101 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Aged 18 years or older, any sex. 2. 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-...

Countries:China
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