Safety & Pharmacokinetic Study of IMM0306 in Patients With NCT04746131

Updated 05/03/2024

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

Related Conditions & MeSH terms

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
	Recruiting	`NCT05453669` - Clinical Study of the Efficacy of CD19-CAR-DNT Cells in the Treatment of Relapsed/Refractory B-cell NHL	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	`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