Clinical trials

9

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

A Study of IMM0306 in IgG4-Related Disease

The goal of this clinical trial is to learn if IMM0306 works to reduce the risk of disease relapse in participants with IgG4-related disease (IgG4-RD). It will also learn about the safety and tolerability of IMM0306. The main questions it aims to answer are: * Does IMM0306 reduce the risk of disease relapse in participants with IgG4-RD? * What medical problems do participants have when receiving IMM0306? * How does IMM0306 behave in the body, and does the body develop anti-drug antibodies against IMM0306? In the Phase II part, all participants will receive IMM0306. In the Phase III part, researchers will compare IMM0306 with placebo to evaluate whether IMM0306 reduces the risk of disease relapse in participants with IgG4-RD. Participants will: * Receive IMM0306 or placebo by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later * Start a planned glucocorticoid taper from Day 1 and gradually reduce oral prednisone or equivalent until complete discontinuation after 8 weeks * Visit the study site for efficacy and safety assessments, including disease relapse assessment, IgG4-RD responder index assessment, laboratory tests, imaging examinations, electrocardiograms, pharmacokinetic sampling, immunogenicity sampling, biomarker sampling, and adverse event assessment.

Participants needed: 125
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Updated: Jun 2, 2026
Eligibility criteria

Clinical diagnosis of IgG4-RD; [+3]

Fibrotic manifestation as the only clinical manifestation of the current relapse... [+10]

Status: Recruiting

A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome.

A two-center, randomized, double-blind, placebo-controlled, dose-escalation IIT clinical study evaluating the safety and preliminary efficacy of injectable IMC-001 in improving atherosclerotic plaque stability in patients with acute coronary syndrome. The plan is to conduct 2 dose groups, with 9 subjects enrolled in each group, including 6 in the treatment group and 3 in the control group. The treatment group will receive IMC-001 along with optimal drug therapy, with a total of 12 subjects included, while the control group will receive a placebo along with optimal drug therapy, with a total of 6 subjects included.

Participants needed: 18
Trial details
Phase: Early Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Updated: Apr 15, 2026Locations: 2
Eligibility criteria

Fully comprehend the purpose, characteristics, methodology, and potential advers... [+3]

Participation in any drug or medical device clinical trial within one month prio... [+17]

Status: Not yet recruiting

IMM0306 in Combination With Lenalidomide vs Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma

This study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed/Refractory Follicular lymphoma. Primary endpoints are Complete Remission Rate (CRR) and Progression-Free Survival (PFS).

Participants needed: 198
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Updated: Jan 27, 2026Locations: 1
Eligibility criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. [+5]

Autologous HSCT within 100 days prior to first administration, or any prior allo... [+8]

Status: Recruiting

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMC-003 for Injection in Healthy Postmenopausal Women

this study is a randomized, double-blind, placebo-controlled, single and multiple dose escalation Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IMC-003 for injection in healthy postmenopausal women.

Participants needed: 56
Trial details
Phase: Phase 1Age: 45-75Biological sex: FemaleType: InterventionalSponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Updated: Dec 15, 2025Locations: 1
Eligibility criteria

(1) The age range for screening is 45 to 75 years (inclusive of the boundary val...

Status: Recruiting

IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

This study is a randomized, controlled, double-blind, multicenter, phase Ⅲ clinical study to evaluate the efficacy of IMM01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (CMML1-2).Primary endpoint are Complete remission rate and Overall survival.

Participants needed: 170
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Updated: Nov 25, 2025Locations: 43
Eligibility criteria

Age ≥ 18 years old, regardless of gender; [+5]

Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein; [+4]

Status: Not yet recruiting

A Study of IMM2510 + IMM01 Combination Therapy in Patients With Advanced Solid Tumors

This is a Phase 1, open-label, dose-escalation and cohort expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant protein) combine with IMM01(Anti-CD47 Recombinant Protein) in patients with advanced solid tumors who have received at least first line treatment in past.

Participants needed: 104
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Updated: Sep 12, 2025Locations: 1
Eligibility criteria

Participant has provided informed consent prior to initiation of any study speci... [+4]

History of other malignancy within the past 5 years with exceptions. [+4]

Status: Recruiting

A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Solid Tumors

This study is an open-label, multi-centre, single-arm, phase I clinical study, to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of IMM2510 (an anti-PD-L1/VEGF bispecific antibody fusion protein) + IMM27M (a humanized Fc-engineered anti-CTLA-4 antibody) combination therapy in patients with advanced solid tumors.

Participants needed: 108
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Updated: Jan 8, 2025Locations: 1
Eligibility criteria

The patient can understand the procedures and methods of this clinical trial. Af... [+7]

Patients who received mitomycin and nitrosourea chemotherapy within 6 weeks befo... [+31]

Status: Not yet recruiting

A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer

This is a single-arm, multicenter, open-label Phase II clinical study evaluating the efficacy and safety of IMM2510 in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent NSCLC or unresectable locally advanced or metastatic TNBC. The target population includes: Cohort 1: Patients with histologically or cytologically confirmed stage IV metastatic or recurrent NSCLC who are EGFR wild-type and negative for ALK or ROS1 fusion genes, and who have not received prior systemic treatment for NSCLC; Cohort 2: Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic TNBC who are negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER-2), and who have not received prior systemic treatment for TNBC; This study is divided into two phases. Phase I is the safety run-in period, which will preliminarily explore the safety and PK profile of IMM2510 in combination with chemotherapy in patients with NSCLC or TNBC who have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment, to determine the dose for the combination treatment. Phase II is the expanded enrollment period, which will enroll NSCLC patients (Cohort 1; where Cohort 1a is for NSQ-NSCLC and Cohort 1b is for SQ-NSCLC), or TNBC patients (Cohort 2), according to the dose for the combination treatment determined in Phase I, to further explore the preliminary clinical efficacy, safety, and PK profile of IMM2510 in combination with chemotherapy as first-line treatment in patients with NSCLC or TNBC.

Participants needed: 148
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Updated: Dec 24, 2024
Eligibility criteria

Fully understand and voluntarily sign the ICF for this study ; [+8]

Received approved or investigational anti-tumor treatments within 4 weeks prior... [+9]

Status: Not yet recruiting

A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma

The purpose of this study is to compare efficacy of IMM01 plus Tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of IMM01 plus Tiselizumab. The primary study hypotheses are that IMM01 plus Tiselizuma is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).

Participants needed: 202
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.Updated: Jun 24, 2024
Eligibility criteria

Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL). [+2]

History of central nervous system (CNS) metastases or active CNS involvement. [+5]