Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma

NCT05805943 | Unknown Phase 1 DMC

• 1 other identifier: IMM0306-I
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of IMM0306 in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R B-NHL).

Conditions

CD20-positive B-cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity

  Evaluated for DLTs during the first 28-day cycle

• Complete response rate

  up to 52 weeks

Study Arms (1)

IMM0306 Monotherapy

EXPERIMENTAL

Phase I dose escalation part, participants with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) will be enrolled to receive IMM0306. The dose of IMM0306 will depend on when you join this study. About 1-6 participants will be enrolled at each dose level. Phase II dose expansion part, participants will receive IMM0306 at the recommended dose that was found in dose escalation part.

Drug: IMM0306

Interventions

IMM0306 DRUG

IMM0306 is an bi-specific antibody

IMM0306 Monotherapy

Eligibility Criteria

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

You may qualify if:

• Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that has been diagnosed, including but not limited to diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL), mucosal lymphoma (MALT-L), small lymphocytic lymphoma (SLL) / chronic lymphocytic leukemia (CLL).
• At least one measurable or assessable tumor lesion.
• Adequate organ and hematologic function.
• Eastern Co-operative Oncology Group (ECOG) score 0 to 2.
• All adverse events from prior treatment must be CTCAE v5.0 grade \<= 1

You may not qualify if:

• Active central nervous system (CNS) lymphoma.
• Systemic steroid therapy (dose equivalent to \> 10 mg prednisone / day).
• History of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (CTCAE v5.0 grade \>=3).
• Have evidence of severe uncontrollable active infection.
• Subjects have deep vein embolism or pulmonary embolism within 6 months before screening.

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Related Publications (1)

• Yang J, Song Y, Zhou K, Li Z, Zhang M, Jing H, Wang Z, Yu L, Meng W, Lu Q, Tian W, Shi Y. Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPalpha, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study. J Hematol Oncol. 2024 Dec 18;17(1):123. doi: 10.1186/s13045-024-01646-2.

  PMID: 39696680 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 10, 2023
• Study Start: March 2, 2020
• Primary Completion: May 25, 2025
• Study Completion: May 25, 2025
• Last Updated: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)