The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed/Refractory B-cell Non Hodgkin Lymphoma

Sponsor
Imbioray (Hangzhou) Biomedicine Co., Ltd.
Study ID
NCT07073833
Phase
PHASE1
Status
Recruiting
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Conditions

  • Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IBR900 cell injection — DRUG
    NK cells
  • rituximab — DRUG
    CD20 antibody

Study Details

This is an open label clinical study: Phase Ia is a dose escalation phase, evaluating the safety, tolerability, RP2D, PK characteristics, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed/refractory B-cell non Hodgkin lymphoma (NHL); Phase Ib is the dose expansion stage, which is divided into two parts: monotherapy expansion (queue 1) and combination expansion (queue 2). The monotherapy expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed/refractory CD20 positive B-cell non Hodgkin lymphoma, while the combination expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection combined with CD20 monoclonal antibodies in the treatment of relapsed/refractory CD20 positive B-cell non Hodgkin lymphoma.

Key Dates

Start date
Jul 20, 2025
Status verified
Jul 2025
Primary completion
Jul 30, 2027
Completion
Jul 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ia，single-agent dose escalation of IBR900 cell injection
  • Experimental: Phase Ib，monotherapy expansion (queue 1)
  • Experimental: Phase Ib，combination expansion (queue 2)

Primary Outcome Measure

Incidence of dose limiting toxicity (DLT) [ Time Frame: From day1 to day 21 ]

Central Contacts