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New hope for tough lymphoma: experimental drug shows promise

NCT ID NCT03494179

Disease control Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called ICP-022 in 106 adults with mantle cell lymphoma that had come back or stopped responding to prior treatments. The goal was to see if the drug could shrink tumors and to check its safety. The approach focuses on controlling the disease rather than curing it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

106 people

The number who actually took part.

Started

Apr 2018

Finished

Apr 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women between 18 and 75 years old * Histologically confirmed mantle cell lymphoma (MCL), with either t(11;14) by cytogenetics and/or cyclin D1 overexpression by immunohistochemistry (IHC) * Subjects with refractory or relapsed mantle cell lymphoma who has received at least 1 but no more than 4 prior therapies for MCL * At least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI * ECOG performance status of 0-2 * Documented failure to achieve at least partial response (PR) or documented disease progression after response to, the most recent treatment regimen. * Subjects who meet the following laboratory parameters: 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L Platelet count ≥ 75×109/L, independent of growth factor support within 7 days of the first dose with study drug, Hemoglobin ≥ 80 g/L; ANC ≥ 1.0×109/L, Platelet count ≥ 50×109/L if bone marrow involvement 2. Total bilirubin ≤ 2× ULN; AST or ALT ≤ 2.5 ULN; Creatinine clearance ≥ 30ml/min; Amylase ≤ ULN and Lipase ≤ ULN 3. International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (APTT) ≤ 1.5 ULN * Life expectancy ≥ 4 months * Able to provide signed written informed consent Exclusion Criteria: * History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis * Current or history of lymphoma involved central nervous system * Prior corticosteroids (at dosages equivalent to prednisone \> 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody based therapies or anti-cancer TCM within 4 weeks of the start of study drug. * Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy * Current clinically significant cardiovascular disease including: * Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) \< 50% * Primary cardiomyopathy * Clinical significant QTc prolong history or QTc\>470ms (female) QTc\>450ms (male) * Uncontrolled hypertension * Known active bleeding within 2 months of screening or currently taking anticoagulant/antiplatelet drugs * Urine protein ≥ 2+ and quantitation ≥ 2g/24hours * History of deep vein thrombosis or pulmonary embolism * Disease significantly affecting gastrointestinal function such as dysphagia, chronic diarrhea, intestinal obstruction, or resection of the stomach * Allogeneic stem cell transplant within 6 months prior to first dose of study drug or related active infection * Major surgery within 6 weeks of screening, except for diagnostic test or vascular access setup * Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection * Any history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe lung function impairment * Prior exposure to a BTK inhibitor，BCR pathway ingibitor(such as PI3K, SYK) or BCL-2 kinase inhibitor * Suitable and ready for allogeneic stem cell transplant * Inability to comply with study procedures * Drug abuser or alcoholics * Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children * Requires treatment with moderate or strong cytochrome P450 family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers.

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Conditions

The condition(s) this trial relates to.

mantle cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mantle cell lymphoma

Contacts and locations

Locations

  • Anhui Province Cancer Hospital

    Hefei, Anhui, 230009, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 102206, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180, China

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003, China

  • Henan Tumor Hospital

    Zhengzhou, Henan, 450008, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012, China

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191, China

  • Qilu Hosptial of Shandong University

    Jinan, Shandong, 250012, China

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266071, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Zhengjiang University

    Hangzhou, Zhejiang, 310003, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Hospital of China Medical University

    Shenyang, Liaojing, 110001, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052, China

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116044, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tongji Hospital

    Wuhan, Hubei, 430030, China

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610041, China

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022, China

  • Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicin

    Shanghai, Shanghai Municipality, 200092, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.