A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
NCT ID: NCT05279300
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
480 participants
INTERVENTIONAL
2022-03-28
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose escalation
CS5001
The dose and dosing schedule is decided by the Safety Monitoring Committee.
Dose expansion
CS5001
The dose and dosing schedule is decided by the Safety Monitoring Committee.
Rituximab
IV infusion
Gemcitabine
IV infusion
Oxaliplatin
IV infusion
Lenalidomide
PO
Cyclophosphamide
IV infusion
Doxorubicin
IV infusion
Vincristine
IV infusion
Prednisone
PO
Interventions
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CS5001
The dose and dosing schedule is decided by the Safety Monitoring Committee.
Rituximab
IV infusion
Gemcitabine
IV infusion
Oxaliplatin
IV infusion
Lenalidomide
PO
Cyclophosphamide
IV infusion
Doxorubicin
IV infusion
Vincristine
IV infusion
Prednisone
PO
Eligibility Criteria
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Inclusion Criteria
* For Lymphoma patients of dose escalation, they must have pathologically confirmed Hodgkin and non-Hodgkin B-cell lymphoma as defined per 2016 World Health Organization(WHO) classification, with disease progression on or after at least 2 lines of prior systemic therapy.
* For mono-therapy cohorts, eligible patients must have pathologically confirmed relapsed/refractory (R/R) lymphomas or advanced solid tumors, and have demonstrated failure with previous line(s) of standard-of-care treatment. Patients in the solid tumor cohort must exhibit ROR1-positive expression in their baseline tumor tissues. For combination therapy cohorts, DLBCL patients must either be treatment-naïve or have experienced failure with at least one prior line of standard-of-care therapy to qualify for treatment with CS5001 in combination with first-line or subsequent standard-of-care therapies for DLBCL. Solid tumor patients must have pathologically confirmed disease, be naïve to PD-1/PD-L1 inhibitors, and have at least failed first-line therapy or standard-of-care treatment.
* For dose escalation, with at least one evaluable lesion as defined per Response Evaluation Criteria in Solid Tumours(RECIST) v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively. For dose expansion, with at least one measurable lesion as defined per RECIST v1.1 solid tumor or per 2014 Lugano Classification Criteria for lymphoma, respectively.
* Life expectancy \> 3 months.
* Eastern Cooperative Oncology Group(ECOG) performance status 0-2.
* Have adequate organ function.
Exclusion Criteria
* Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
* For dose expansion: Participation in other studies involving therapies targeting ROR1 prior to study entry and/or during study participation.
* Has known central nervous system (CNS) lymphoma or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy.
* Has other acute or chronic medical or psychiatric conditions.
* Has a diagnosis of immunodeficiency, or has an active autoimmune disease or other conditions that require systemic steroid therapy.
* Has peripheral edema, pericardial effusion, or ascites indicated for medical intervention or limiting activity of daily life. Or with a known history of peripheral vasculopathies.
* Patients with any active infections requiring systemic therapy within 2 weeks prior to the administration of the first dose of the study drug.
* Patients known to be human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS).
* Significant cardiovascular disease within 6 months prior to the first dose of the study drug.
* Significant screening electrocardiogram (ECG) abnormalities.
* Has received major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the administration of the first dose of the study drug.
* Administration of a live vaccine within 28 days prior to the administration of the first dose of the study drug.
* Has active graft versus host disease.
* With known active alcohol or drug abuse.
* Women who are pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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CStone Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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North Shore Hematology Oncology Associates
East Setauket, New York, United States
Columbia U. - Herbert Irving Comprehensive Cancer Center
New York, New York, United States
BUMC - Mary Crowley Cancer Research Centers (MCCRC)
Dallas, Texas, United States
Scientia Clinical Research Limited
Randwick, New South Wales, Australia
Ashford Cancer Centre Research
Adelaide, South Australia, Australia
Central Adelaide Local Health Network Incorporated
Adelaide, South Australia, Australia
Royal Adelaide Hospital (RAH)
Adelaide, South Australia, Australia
Epworth Freemasons Medical Centre
East Melbourne, Victoria, Australia
Epworth Foundation trading as Epworth HealthCare
Melbourne, Victoria, Australia
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Anhui Provincial Hospital,
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Yanda Lu Dao Pei Hospital
Beijing, Beijing Municipality, China
The Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Guangdong Province Hospital
Guangzhou, Guangdong, China
Sun YatSen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumour Hospital
Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu province hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhu, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The first Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CS5001-101
Identifier Type: -
Identifier Source: org_study_id
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