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New drug doses tested for rare blood cancer

NCT ID NCT05978739

Disease control Sponsor: InnoCare Pharma Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial tested two different daily doses of the drug orelabrutinib in 40 people with mantle cell lymphoma, a rare blood cancer. The goal was to see which dose works better at shrinking tumors and controlling the disease. Participants included both newly diagnosed and relapsed patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Orelabrutinib
What this could lead to
If successful, this could help determine the best dose of orelabrutinib to control mantle cell lymphoma with fewer side effects.
What could go wrong
This is a small, early-phase trial with only 40 participants. Results may not apply to all patients, and the drug may not work as well as hoped or could cause unexpected side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Aug 2023

Finished

Dec 2024

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 years and older

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: 1. Male and female subjects ≥ 18 years of age. 2. Mantle cell lymphoma (MCL) confirmed by histopathology. 3. Subjects who have not previously received standard systemic care and relapsing/refractory subjects who have previously received standard systemic care. 4. At least one measurable lesion. 5. ECOG Physical fitness score 0-2 points. 6. Expected survival time ≥ 4 months. 7. Full hematology function. 8. Blood clotting function is basically normal. 9. Subjects with basically normal liver, kidney and heart function. 10. Subject voluntarily signs a written ICF. 11. The serum pregnancy test of female subjects with fertility potential was negative within 7 days before the first dosing. 12. Female subjects with reproductive potential or male subjects and their partners must agree to use effective contraception for at least 6 months from signing the ICF until the last dose of the study drug. Exclusion Criteria: 1. Adequate treatment with BTK inhibitors. 2. Have a history of severe allergic disease and a history of severe drug allergy. 3. Subjects who have received the treatment or drug restricted in the protocol within the time specified for the first use of the investigational drug. 4. The last use of a potent CYP3A inhibitor or potent CYP3A inducer (including food, western medicine, and Chinese medicine) was less than 2 weeks (or less than 5 half-lives, depending on the time) from the first trial, or plan to take a potent CYP3A inhibitor or potent CYP3A inducer drug or food during the study period. 5. History of other active malignant diseases within 2 years prior to screening. 6. Subjects with systemic bacterial, viral, fungal (other than nail fungal infections) or parasitic infections with poorly controlled activity. 7. Indicates active hepatitis B or C virus infection. 8. There are diseases that are excluded from the criteria in the programme. 9. Toxicity of previous anticancer therapy was still ≥ grade 2 at the start of study therapy (according to CTCAE V5.0). 10. History of severe bleeding disorder. 11. People with a known history of alcohol or drug abuse. 12. Subjects with mental disorders or poor compliance. 13. Pregnant or lactating female subjects. 14. Other conditions deemed unsuitable for participation in this study by the investigator.

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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

  • Chenzhou First People's Hospital

    Chenzhou, Hunan, 423003, China

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031, China

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029, China

  • Nanyang Second General Hospital

    Nanyang, Henan, 473009, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013, China

  • Sun Yat-sen University Cancer Center

    Guangdong, Guangzhou, 510055, China

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Uygur Autonomous Region, 830000, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233040, China

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004, China

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116023, China

  • Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

More trials for these conditions

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