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

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 ot

Trial Details

NCT ID
NCT07376642
Phase
EARLY_PHASE1
Sponsor
Suzhou Immunofoco Biotechnology Co., Ltd
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • IMV101 treatment
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Zhengzhou, Henan, China|34.75778,113.64861
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • 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: …
  • CD19 positivity confirmed by pathology or flow cytometry analysis (subjects with prior exposure to CD19-targeted therapies must undergo repeat biop…
  • Relapsed/refractory B-cell non-Hodgkin lymphoma meeting at least one of the following criteria:

For full eligibility, visit ClinicalTrials.gov.

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