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

Back to results

Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

IMM0306

About this trial

This is an interventional treatment trial for CD20-positive B-cell Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

Cancer Hospital Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMM0306 Monotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Dose-limiting toxicity

Complete response rate

Secondary Outcome Measures

Full Information

NCT ID

NCT05805943

First Posted

March 24, 2023

Last Updated

April 6, 2023

Sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05805943

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 2, 2020 (Actual)

Primary Completion Date

May 25, 2025 (Anticipated)

Study Completion Date

May 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IMM0306 Monotherapy

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

IMM0306

Intervention Description

IMM0306 is an bi-specific antibody

Primary Outcome Measure Information:

Title

Dose-limiting toxicity

Time Frame

Evaluated for DLTs during the first 28-day cycle

Title

Complete response rate

Time Frame

up to 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Facility Information:

Facility Name

Cancer Hospital Chinese Academy of Medical Sciences

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuankai Shi

Phone

010-87788268

12. IPD Sharing Statement

Plan to Share IPD

No

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

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial