Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

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.

IMM0306

Yuankai Shi

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).

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

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

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

IMM0306 Dose escalation: 0.1mg/kg, 0.2mg/kg, 0.4mg/kg, 0.8mg/kg,1.2mg/kg and 1.6mg/kg through intravenous administration weekly up to 52 weeks.

Cheng Huang, MD

The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL).

Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)

DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1.

Worldwide Clinical Trials

Antineoplastic Agents

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

In this study, lenalidomide was administered at a fixed dose, in which 25 mg was used for DLBCL patients,and 20mg was used for other B-NHL patients such as FL, MZL, MCL, etc. and daily oral therapy with IMM0306 was used on the 1\~21st day of each repeat 28-day cycle.

The RP2D of the IMM0306 monotherapy trial was administered once a week (7 days ± 1 day) for intravenous infusion every 4 weeks

IMM0306 is a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα. The Fc segment of the recombinant protein in IMM0306 is IgG1 and has been modified by ADCC-enhanced genetic engineering.

Chemical name 3-(7-amino-3-oxo-1H-isoindol-2-yl)piperidin-2,6-dione, molecular formula C 13H 13 N 3 O 3, is an anti-tumor drug developed by Celgene Biopharmaceutical Company in the United States, with multiple effects such as anti-tumor, immunomodulatory and anti-angiogenesis

Lenalidomide capsule

jinhua zhou

The objective of this study was to evaluate the safety and efficacy of IMM0306 in combination with lenalidomide in patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma.

Main study purpose:

To assess the safety and tolerability of IMM0306 in combination with lenalidomide to determine the maximum tolerated dose (MTD) (if available) and the recommended Phase 2 dose (RP2D).

Secondary study purpose

1. To assess the antitumor efficacy of IMM0306 in combination with lenalidomide.
2. To assess the immunogenicity of IMM0306 in combination with lenalidomide.
3. To evaluate the pharmacokinetic (PK) profile of IMM0306 in combination with lenalidomide.

Exploratory study purpose:

1. Explore the correlation between exposure to IMM0306 and efficacy and safety (data permitting).
2. Explore the correlation of biomarkers with safety.

A Clinical Study of Injectable IMM0306 in Combination With Lenalidomide

A Phase Ib/IIa Clinical Study of IMM0306 fo r Injection in Combination With Lenalidomide for the Treatment of Relapsed/Refractory CD20-Positive B-Cell Non-Hodgkin's Lymphoma Cell Non-Hodgkin's Lymphoma

To be summarized using descriptive statistics

If the planned dose escalation of IMM0306 in combination with lenalidomide to a preset highest dose group (i.e., the single-agent RP2D dose recommended in the IMM0306-I trial) does not reach MTD, it will be possible to continue to increase the dose exploration or explore new frequency of administration. SMC will also review pre-safety data and recommend whether to further increase the dose and explore new dosing frequencies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma	NCT05805943	CD20-positive B...	IMM0306	18 Years -	ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)	NCT04746131	B-cell Non-Hodg...	IMM0306	18 Years - 75 Years	ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
A Clinical Study of Injectable IMM0306 in Combination With Lenalidomide	NCT05771883	B-cell Non-Hodg...	IMM0306 Lenalidomide ca...	18 Years -	ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma	NCT05805943	CD20-positive B...	IMM0306	18 Years -	ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Spots Global Cancer Trial Database for imm0306

Every month we try and update this database with for imm0306 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for imm0306

Every month we try and update this database with for imm0306 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for imm0306 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.