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Mantle Cell LymphomaPhase 1/2NCT03494179

A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL)

A Phase 1/2 study testing ICP-022 in people with Mantle Cell Lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 31 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The phase I/II clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of ICP-022. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
ICP-022
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
31 sitesChina
Study dates
2 Apr 2018to 10 Apr 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Subjects who meet the following laboratory parameters:
  • 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
  • Total bilirubin ≤ 2× ULN; AST or ALT ≤ 2.5 ULN; Creatinine clearance ≥ 30ml/min; Amylase ≤ ULN and Lipase ≤ ULN
  • 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

Who cannot join

  • 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%
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  • 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.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 102206

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610041

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116044

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The First Affiliated Hospital of Zhengjiang University

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

  • Anhui Province Cancer Hospital

    Hefei, Anhui, 230009

  • Qilu Hosptial of Shandong University

    Jinan, Shandong, 250012

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266071

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

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

    Shanghai, Shanghai Municipality, 200092

  • The First Hospital of China Medical University

    Shenyang, Liaojing, 110001

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • Tongji Hospital

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • Henan Tumor Hospital

    Zhengzhou, Henan, 450008

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)

The phase I/II clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of ICP-022.

Read the detailed description

Part I: PK/PD and safety evaluation -Two regimens of ICP-022 (High dose QD and low dose BID) were designed for assessment of safety, as well as PK/PD profiles. The recommended dose of phase II clinical study will be determined according to the Part I results.

Part II: Dose expansion -Anti-tumor effects of ICP-022 in Chinese patients with R/R MCL will be evaluated in approximately 80 subjects. The recommended Phase 2 dose will be used in the Part II.

Being tested
ICP-022
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP-022Drug

    The drug product is a white, round, uncoated tablet.

Study groups in NCT03494179
Study groupRoleWhat they receive
High Dose of ICP-022ExperimentalTwo regimens of ICP-022 (High dose QD and low dose BID) are designed for study Part I to determine RP2D which will be used in Part II to further evaluate the preliminary anti-tumor effects of ICP-022 in Chinese subjects with R/R MCL.
Receives: Drug: ICP-022
Low Dose of ICP-022ExperimentalTwo regimens of ICP-022 (High dose QD and low dose BID) are designed for study Part I to determine RP2D which will be used in Part II to further evaluate the preliminary anti-tumor effects of ICP-022 in Chinese subjects with R/R MCL.
Receives: Drug: ICP-022

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate (ORR)

    The efficacy measured by overall response rate (ORR) in Part II according to the 2014 International Working Group NHL

    Measured: Up to 3 years

Secondary outcomes (10)

  1. Occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I

    The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I

    Measured: Up to 3 years

  2. time to progression (TTP)

    The efficacy measured by time to progression (TTP) in Part II

    Measured: Up to 3 years

  3. progression free survival (PFS)

    The efficacy measured by progression free survival (PFS) in Part II

    Measured: Up to 3 years

  4. overall survival (OS)

    The efficacy measured by overall survival (OS) in Part II

    Measured: Up to 3 years

  5. Area under the concentration time curve up to the time "t" (AUC(0-t))

    Area under the concentration time curve up to the time "t" (AUC(0-t)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.

    Measured: up to 4 weeks

  6. The percent of target occupancy

    PBMC from individual subject before and after dosing will be collected and the target occupancy will be determined by ELISA. The percent of target occupancy will be compared descriptively.

    Measured: up to 4 weeks

  7. Maximum plasma drug concentrations (Cmax)

    Individual plasma concentrations of ICP-022 will be measured and Cmax will be calculated with noncompartmental analysis using WinNonlin.

    Measured: up to 4 weeks

  8. Time of maximum plasma drug concentrations (Tmax)

    Time of maximum plasma drug concentrations (Tmax) of ICP-022 will be recorded.

    Measured: up to 4 weeks

  9. Apparent half-life for designated elimination phases (t½)

    Apparent half-life for designated elimination phases (t½) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.

    Measured: up to 4 weeks

  10. Area under the concentration time curve up to the last data point above LOQ (AUC(last))

    Area under the concentration time curve up to the last data point above LOQ (AUC(last)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.

    Measured: up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2018
  2. Study start2 Apr 2018
  3. Primary completion10 Apr 2020
  4. Study completion10 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03494179
Sponsor's protocol ID
ICP-CL-00102
Status last verified
Jun 2026
First submitted
19 Mar 2018
Last updated
8 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Deng LJ, Zhou KS, Liu LH, Zhang MZ, Li ZM, Ji CY, Xu W, Liu T, Xu B, Wang X, Gao SJ, Zhang HL, Hu Y, Li Y, Cheng Y, Yang HY, Cao JN, Zhu ZM, Hu JD, Zhang W, Jing HM, Ding KY, Zhang XY, Zhao RB, Zhang B, Tian YM, Song YP, Song YQ, Zhu J. Orelabrutinib for the treatment of relapsed or refractory MCL: a phase 1/2, open-label, multicenter, single-arm study. Blood Adv. 2023 Aug 22;7(16):4349-4357. doi: 10.1182/bloodadvances.2022009168.

    PubMed 37078706

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ICP-022 in people with Mantle Cell Lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (ORR) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03494179, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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