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

Sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT05805943
Collaborator
(none)
154
Enrollment
1
Location
1
Arm
62.8
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
154 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
Actual Study Start Date :
Mar 2, 2020
Anticipated Primary Completion Date :
May 25, 2025
Anticipated Study Completion Date :
May 25, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: IMM0306 Monotherapy

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
IMM0306 is an bi-specific antibody

Outcome Measures

Primary Outcome Measures

  1. Dose-limiting toxicity [Evaluated for DLTs during the first 28-day cycle]

  2. Complete response rate [up to 52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Hospital Chinese Academy of Medical Sciences Beijing China

Sponsors and Collaborators

  • ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
ClinicalTrials.gov Identifier:
NCT05805943
Other Study ID Numbers:
  • IMM0306-I
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell

Study Results

No Results Posted as of Apr 10, 2023