Orelabrutinib for B-Cell Malignancies

Not currently recruiting at 40 trial locations

Overseen By Olivia Yang

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Must not be taking: Anticoagulants, CYP3A inhibitors

Disqualifiers: Pregnancy, HIV, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Orelabrutinib, a Bruton's tyrosine kinase inhibitor, for individuals with B-cell malignancies, which are cancers affecting certain white blood cells. The goal is to assess the safety and effectiveness of this treatment for conditions such as Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Follicular Lymphoma (FL), and Marginal Zone Lymphoma (MZL). The trial consists of two parts: the first tests different doses, and the second focuses on the optimal dose identified. Individuals who have previously tried other treatments for their B-cell cancer but require more options might be suitable candidates for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking any chemotherapeutic agents or investigational therapies at least 4 weeks before starting the study drug. You also cannot use warfarin, other vitamin K antagonists, or strong CYP3A inhibitors while participating.

Is there any evidence suggesting that Orelabrutinib is likely to be safe for humans?

Research has shown that Orelabrutinib, a new treatment being tested for B-cell cancers, has promising safety results from earlier studies. In one study, patients with marginal zone lymphoma (MZL), a type of B-cell cancer, responded well to Orelabrutinib when combined with other treatments. The safety profile was favorable, with patients experiencing few serious side effects.

Another study focused on patients who had issues with other BTK inhibitors, a type of cancer drug. These patients also tolerated Orelabrutinib well, suggesting it might be a safer option for those who had problems with similar treatments. Additionally, Orelabrutinib is already approved for treating certain types of lymphoma, further supporting its safety for patients.

Overall, the evidence suggests that Orelabrutinib is generally well-tolerated and has a favorable safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Orelabrutinib is unique because it targets B-cell malignancies with a highly selective mechanism. Unlike standard treatments like ibrutinib, which can affect multiple kinases and lead to broader side effects, orelabrutinib specifically inhibits Bruton's tyrosine kinase (BTK) with greater precision. This selectivity potentially means fewer side effects and improved quality of life for patients. Researchers are excited because this targeted approach could offer a more effective and safer alternative for conditions like chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).

What evidence suggests that Orelabrutinib might be an effective treatment for B-cell malignancies?

This trial examines orelabrutinib's effectiveness in treating various B-cell malignancies. In a previous study, orelabrutinib demonstrated a strong ability to help people with relapsed or refractory mantle cell lymphoma (MCL), achieving an overall response rate of 81.1%. Another study combined orelabrutinib with chemoimmunotherapy for marginal zone lymphoma (MZL), and every patient responded positively. A separate analysis confirmed the effectiveness of orelabrutinib-based treatments for MZL. These studies suggest that orelabrutinib might be a promising option for various B-cell malignancies, and this trial will further explore its potential in different patient groups. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain B-cell malignancies, like relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Participants need to have a life expectancy of at least 4 months, be in good physical condition, and not have active hepatitis or HIV. Pregnant women and those who've had recent major surgeries or other cancer treatments are excluded.

Inclusion Criteria

Negative test results for HBV ([HBsAg (-)] and non-active HBV or HCV infection)

Life expectancy (in the opinion of the investigator) of ≥ 4 months

I am fully active or can carry out light work.

Exclusion Criteria

I am currently taking warfarin, vitamin K antagonists, or strong CYP3A inhibitors.

Pregnant or breast-feeding or intending to become pregnant during the study

I finished IV treatment for an infection less than 14 days ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 involves dose escalation to determine the maximum tolerated dose (MTD) of Orelabrutinib

4 weeks

Multiple visits for dose escalation and monitoring

Dose Expansion

Part 2 involves dose expansion to assess anti-tumor activity in patients with B-cell malignancies

Up to 2 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orelabrutinib (ICP-022)

Trial Overview The study tests Orelabrutinib's safety and effectiveness in two parts: dose escalation to find the right amount of drug that can be given safely, followed by dose expansion to further assess its effects on patients with specific types of B-cell malignancies.

How Is the Trial Designed?

Group I: Part 2 Dose Expansion Experimental Treatment 1 Intervention

Arm 1: Patients with r/r MCL Arm 2: Patients with other types of B-cell malignancies, including: * CLL/SLL with/without prior treatment * r/r FL * r/r MZL

Group II: Part 1 Dose Escalation Experimental Treatment 1 Intervention

Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL

Who Is Running the Clinical Trial?

Beijing InnoCare Pharma Tech Co., Ltd.

Lead Sponsor

Trials

48

Recruited

6,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10432605/

Orelabrutinib for the treatment of relapsed or refractory MCL Orelabrutinib exhibited a favorable efficacy and safety profile in patients with r/r MCL. Overall response rate was 81.1%, with 27.4% achieving complete ...

2. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/3039/500123/Orelabrutinib-Monotherapy-in-Patients-with

Orelabrutinib Monotherapy in Patients with Relapsed or ... We present here the long-term results of this study. Methods. This is a prospective, multicenter study of orelabrutinib in patients with WM who ...

3. bloodcancerstoday.com bloodcancerstoday.com/post/orelabrutinib-emerges-with-promising-results-in-advanced-marginal-zone-lymphoma

Orelabrutinib Emerges With Promising Results in ... A phase II trial found orelabrutinib combined with chemoimmunotherapy produced a 100% response rate in relapsed/refractory MZL, with good ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12085368/

Indirect Comparisons of Efficacy of Zanubrutinib Versus ... Our previous study has suggested a favorable progression-free survival (PFS) with zanubrutinib over orelabrutinib in patients with relapsed or refractory ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124091596

A Retrospective Analysis of Orelabrutinib-Containing ... This retrospective study preliminarily confirmed that orelabrutinib-containing regimens are effective and safe for treating MZL.

6. innocarepharma.com innocarepharma.com/en/news/activity/en020250425

InnoCare Announces Approval of Orelabrutinib for the First ... The approval of the first-line CLL/SLL treatment will enable orelabrutinib to benefit an even broader population of lymphoma patients.

7. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/4399/532387/Orelabrutinib-in-Patients-with-Indolent-Non

Orelabrutinib in Patients with Indolent Non-Hodgkin ... A phase 2 study (ChiCTR2400080207) is being conducted to assess the safety and efficacy of orelabrutinib in prior BTKi-intolerant iNHL patients, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0006497123127443

Effectiveness and Safety of Orelabrutinib Combined with ... This retrospective data suggests that orelabrutinib with rituximab has an encouraging anti-tumor activity in MZL, with a favorable safety profile.