Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04807881

Phase Ib Clinical Study of Keynatinib

Led by Medolution Ltd. · Updated on 2025-01-22

75

Participants Needed

4

Research Sites

393 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the efficacy, safety, PK characteristics in subjects with relapsed/refractory B-cell lymphoma. Furthermore, the relationship between the exposure level of Keynatinib and its efficacy and safety, the penetration rate of keynatinib in the Blood-Brain Barrier (BBB) and its PK characteristics in cerebrospinal fluid in R/R-PCNSL patients, the relationship between the BTK receptor occupancy rate and the efficacy are also evaluated.

CONDITIONS

Official Title

Phase Ib Clinical Study of Keynatinib

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Voluntary participation with signed informed consent
  • Diagnosis of relapsed or refractory B-cell lymphoma meeting cohort-specific criteria: Cohort 1: Pathologically confirmed primary central nervous system lymphoma (PCNSL) with prior first-line CNS lesion treatment and measurable progressive lesions on MRI or CT Cohort 2: Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) diagnosed by IWCLL 2008 standards, refractory or relapsed after at least one systemic treatment, with measurable lesions on CT/MRI Cohort 3: Mantle cell lymphoma confirmed by histopathology with prior treatment failure of 1 to 3 chemotherapies or targeted drugs and measurable lesions on CT/MRI
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Estimated survival of at least 4 months
  • Adequate organ function including specified blood counts and liver, kidney, and coagulation parameters
  • Fertile female subjects must agree to use effective contraception or abstinence during the study and for 90 days after last dose; male subjects must use contraception and avoid sperm donation for 90 days after last dose
Not Eligible

You will not qualify if you...

  • PCNSL patients with T-cell lymphoma diagnosis
  • Recent treatment within 4 weeks or 5 half-lives of chemotherapy, targeted therapy, radiotherapy, antibody therapy, BCR inhibitors, BCL-2 inhibitors, CAR-T, or bispecific antibodies
  • Prior allogeneic hematopoietic stem cell transplant or other organ transplant (except autologous SCT over 6 months ago)
  • Use of high-dose corticosteroids or immunosuppressants as specified
  • Other malignancies within 3 years except certain curable skin, bladder, cervical, or breast cancers
  • Unresolved toxicities from prior treatments above grade 1 (except hair loss)
  • Severe or uncontrolled cardiovascular diseases including heart failure, arrhythmia, cardiomyopathy, prolonged QTc, or uncontrolled hypertension
  • Active bleeding or bleeding tendency, history of deep vein thrombosis or pulmonary embolism
  • Recent stroke or intracranial hemorrhage within 6 months
  • Significant gastrointestinal conditions affecting drug absorption
  • Serious or active infections including uncontrolled HIV, hepatitis B or C
  • History of pulmonary fibrosis, interstitial pneumonia, or severe lung impairment
  • Major surgery within 4 weeks before first dose without recovery
  • Participation in other clinical trials within 4 weeks before screening
  • History of alcohol or drug abuse
  • Pregnant or lactating women
  • Concurrent use of strong CYP3A inhibitors or inducers
  • Other conditions deemed unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Not Yet Recruiting

2

Peking University Third Hospital

Beijing, Beijing Municipality, China, 100083

Actively Recruiting

3

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

4

West China Hospital，Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

Loading map...

Research Team

J

Jin Yan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here