Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04746131
Other study ID # IMM0306
Secondary ID
Status Suspended
Phase Phase 1
First received
Last updated
Start date January 15, 2021
Est. completion date April 11, 2024

Study information

Verified date April 2022
Source ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Suspended
Enrollment 90
Est. completion date April 11, 2024
Est. primary completion date April 11, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 18-75 years old - Diagnosed with B-NHL - Relapsed after or be refractory to at least 2 line of standard therapy Exclusion Criteria: - Active central nervous system (CNS) metastases - Positive Direct Antiglobulin Test (DAT) - Active autoimmune disorder - Skin disorders that do not requires hormone replacement therapy

Study Design


Intervention

Drug:
IMM0306
IMM0306 is an bi-specific antibody

Locations

Country Name City State
United States The Christ Hospital Cincinnati Ohio

Sponsors (2)

Lead Sponsor Collaborator
ImmuneOnco Biopharmaceuticals (Shanghai) Inc. Worldwide Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity) DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1. End of Study (52 Weeks)
See also
  Status Clinical Trial Phase
Completed NCT00588094 - Dose Augmented Rituximab and ICE for Pts With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell NHL Phase 2
Not yet recruiting NCT05091541 - A Phase 1/2 Study of CT120 in Patient With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma Phase 1/Phase 2
Recruiting NCT03639181 - Clinical Trial in Chinese Patients of B-cell Non-Hodgkin's Lymphoma(GB226) Phase 2
Recruiting NCT06104553 - A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma Phase 1/Phase 2
Terminated NCT01352312 - Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma Phase 1
Not yet recruiting NCT05771883 - A Clinical Study of Injectable IMM0306 in Combination With Lenalidomide Phase 1/Phase 2
Not yet recruiting NCT06314828 - A Tolerability, Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL Phase 1
Enrolling by invitation NCT05332054 - Long-Term Follow-up Study
Suspended NCT04697290 - CD19/CD20 Dual-CAR-T in B-cell Non-Hodgkin's Lymphoma Patients. Early Phase 1
Completed NCT02564744 - Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL Phase 2
Recruiting NCT05453669 - Clinical Study of the Efficacy of CD19-CAR-DNT Cells in the Treatment of Relapsed/Refractory B-cell NHL Phase 1
Recruiting NCT05190068 - HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma Phase 1
Active, not recruiting NCT00927797 - Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL) Phase 2
Recruiting NCT05436223 - Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma Phase 2
Completed NCT00457782 - A Phase I Safety, PK and PD Study of KW-2478 in Patients With Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's Lymphoma Phase 1
Not yet recruiting NCT03105596 - Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL) Phase 2