Lymphoma, B-CellPhase 1NCT04807881

Phase Ib Clinical Study of Keynatinib

A Phase 1 study testing Keynatinib in people with Lymphoma, B-Cell, run by Medolution Ltd. at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma, B-Cell
What is being tested?: Keynatinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 4 sitesChina
Study dates: 24 Sep 2020to 10 Apr 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Unlimited gender, age ≥ 18 years (including critical value)-Cohort 1/2/3;
Voluntarily participate in the study and sign the ICF, follow the trial treatment protocol and interview plan-Cohort 1/2/3;
The subject's disease diagnosis meets all of the following conditions:
Cohort 1:
Primary central nervous system lymphoma (PCNSL) confirmed by pathology;
For relapsed or refractory PCNSL, at least first line treatment must be given to Central Nervous System (CNS) lesions;

Show all 27Show fewer

Brain Magnatic resonance Imaging (MRI) or Computerized tomography (CT) shows solid lesions of PD;
Cohort 2:
CLL/SLL diagnosed according to IWCLL 2008 standards;
Refractory or relapsed CLL/SLL that previously received at least first-line systemic treatment. First-line treatment is defined as at least 2 cycles of standard protocol or clinical trial research protocol completed based on current guidelines;
Accord with at least one indication of CLL / SLL that requiring treatment;
There is medical record confirming that it is invalid or Progression Disease occurs after response for the latest treatment;
CT /MRI shows measurable lesions, which is defined as at least one lymph node with a maximum axis of more than 1.5 cm and with 2 measurable vertical dimension;
It is allowed to include the patients with a stable condition involving the central nervous system;
Cohort 3:
Mantle cell lymphoma diagnosed by histopathology: including that t (11; 14) (q13; q32) positive by cytogenetic test and / or cyclin D1 highly expressed by immunohistochemistry;
Who have been pretreated with > 1 but failed in ≤ 3 different chemotherapies and / or targeted drugs treatment.
There is a medical record confirming that it is invalid or Progression Disease occurs after response for the latest treatment;
CT / MRI shows measurable lesions, which is defined as the longest diameter (of ≥1 lymph node) > 1.5 cm, and 2 vertical diameters is clearly measurable;
It is allowed to include the patients with a stable condition involving the central nervous system;
When screening, the status score of Eastern Cooperative Oncology Group (ECOG) is 0 to 2 points-Cohort 1/2/3;
Estimated survival time ≥ 4 months-Cohort 1/2/3;
Subjects have appropriate organ functions, the main organ functions meet the following criteria:
Blood routine: Neutrophil absolute value ≥ 1.0(in cohort1, 0.75 in cohort 2/3)×109 /L, platelet ≥ 75(in cohort1, 50 in cohort 2/3, 30×109/L are acceptable if CLL patients have bone marrow involvement, transfusion-dependent thrombocytopenia is excluded )×109 /L, hemoglobin ≥ 80 g/L(in cohort1). [No blood transfusion and hematopoietic stimulating factor are used within 21 days (7 days in cohort 2/3) before the first administration-Chort1];
Blood biochemistry: Total bilirubin (TBIL) ≤ 2 × ULN (unless diagnosed as Gilbert syndrome), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN; serum creatinine ≤ 2 × ULN or creatinine clearance rate ≥ 50 ml / min (calculated according to Cockcroft Gault formula)-Cohort 1/2/3;
Coagulation function: International Standardized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN-Cohort 1/2/3;
Fertile female subjects must agree to use contraceptives with an annual failure rate of < 1% or maintain abstinence (avoid heterosexual intercourse) during the study and at least 90 days after the last administration of the study drug. Contraceptive methods with an annual failure rate of <1% includes bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing IUD (intrauterine devices), and copper-containing IUD. Male subjects must be sterilized by vasectomy or barrier contraception, and female partners should use the effective contraceptives as described above. In addition, male subjects are not allowed to donate sperm within 90 days after the last administration-Cohort 1/2/3.

Who cannot join

Cohort 1: R/R-PCNSL
PCNSL is pathologically diagnosed as T-cell lymphoma;
Have previously received any of the following treatments:
Chemotherapy, targeted therapy, radiotherapy or antibody based anti-tumor therapy are used within 4 weeks before the first administration or within 5 half-lives (whichever is shorter);
Have previously received the treatment of B Cell Receptor (BCR) inhibitors (such as BTK, phosphoinositide kinase 3 kinase [PI3K] or SYK inhibitors) or BCL-2 inhibitors (such as ABT-199) or Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) or a bispecific antibody drug;
Have received Allogenetic Haematopoietic Stem Cell Transplantation (Allo-HSCT) or other organ transplants (except for those who have received ASCT more than six months);

Show all 82Show fewer

Take ≥ 8 mg dexamethasone or equivalent daily to control lymphoma symptoms;
CNS external beam radiotherapy within 21 days before the first administration;
The systemic immunosuppressants, including cyclosporine A, tacrolimus, sirolimus and other drugs, haven't stopped 28 days before the first use of the study drug, or > 5 mg/day of prednisone or its equivalent has been taken for long period;
Have other malignant tumors within 3 years, except for the curable basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast;
Non-hematologic toxicity of the previous anti-tumor treatment has not recovered to ≤ grade 1 (except for hair loss);
Have uncontrollable or severe cardiovascular disease, including:
Congestive heart failure with New York Heart Association (NYHA) grade II or higher, unstable angina, myocardial infarction within 6 months before first study drug administration, or arrhythmia requiring treatment during screening, Left Ventricular Ejection Fraction (LVEF) <50% ;
Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, and atypical cardiomyopathy);
Clinically significant QTc interval prolonged medical history, or the QTc interval of screening period > 470 ms in female, and > 450 ms in male;
Uncontrollable high blood pressure (on the basis of improving life style, with 2 or more antihypertensive drugs (including diuretics) that will be reasonably tolerable and sufficient for more than one month being applied, the blood pressure has not reached to the standard yet, or the blood pressure could only be effectively controlled by taking 4 or more antihypertensive drugs);
Have active bleeding within 2 months before screening or are taking anticoagulant/antiplatelet drugs, or the investigators believe that there is a clear bleeding tendency (such as esophageal varices with bleeding risk, or a locally active ulcer lesions);
Have medical history of deep vein thrombosis or pulmonary embolism;
Have medical history of stroke or intracranial hemorrhage within 6 months before taking the study drug, except for intracranial hemorrhage due to surgical sequelae;
Have clinically significant gastrointestinal abnormalities, which might affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
Have serious or active infection requiring systematic anti infection treatment;
At screening, patients with active uncontrolled infection [such as infection that requiring intravenous antibiotic therapy, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, etc.]; Note: If hepatitis B virus surface antigen (HBsAg) is positive, HBV-DNA < 1000 cop/ml, and ALT/AST ≤ 2.0 × ULN can be included. HCV infection is defined as HCV-Ab positive.
Have past history of or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc;
Have undergone major surgery or have not recovered from the invasive operation within 4 weeks before taking the study drug for the first time and are not suitable for the clinical trial according to the judgment of the investigators;
Who is participating in other clinical studies or have participated in other intervention clinical trials within 4 weeks before screening;
Have history of alcohol or drug abuse;
Pregnant or lactating women;
Concomitant administration of drugs with moderate to severe inhibition or strong induction of cytochrome P450 CYP3A
Subjects determined by the investigators to be unsuitable for other reasons;
Cohort 2: R/R-CLL/SLL
Have medical history of prolymphocytic leukemia, known medical history of Richter syndrome or currently suspected Richter transformation (patients with clinical suspicion need biopsy to exclude transformation)
Have previously received any of the following treatments:
Chemotherapy, targeted therapy, radiotherapy or antibody-based anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first administration;
Previous treatment with BTK, phosphoinositide kinase 3 kinase [PI3K] or SYK inhibitors or BCL-2 inhibitors (such as ABT-199) or chimeric antigen receptor T cell immunotherapy (CAR-T) or treatment with bispecific antibody drugs;
Patients who received allogeneic hematopoietic stem cell transplantation (Allo-HSCT) or other organ transplantation within the past 6 months;
Patients who received autologous hematopoietic stem cell transplantation within the past 6 months;
Use of systemic corticosteroids within 7 days before the first administration of study drug, or continuous use of prednisone at or above 20 mg/day or equivalent;
Other malignancies within 3 years, except for curable basal or squamous cell skin cancer, superficial bladder cancer, and carcinoma in situ of the uterine cervix or breast;
Non-hematologic toxicity of the previous anti-tumor treatment has not recovered to ≤ grade 1 (except for hair loss);
Have uncontrollable or severe cardiovascular disease, including:
Congestive heart failure with New York Heart Association (NYHA) grade II or higher, unstable angina, myocardial infarction within 6 months before first study drug administration, or arrhythmia requiring treatment during screening period, Left Ventricular Ejection Fraction (LVEF) <50%;
Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, and atypical cardiomyopathy);
Clinically significant QTc interval prolonged medical history, or the QTc interval of screening period > 470 ms in female, and > 450 ms in male;
Uncontrollable high blood pressure (on the basis of improving life style, with 2 or more antihypertensive drugs (including diuretics) being applied that will be reasonably tolerable and sufficient for more than one month, the blood pressure has not reached to the standard yet, , or the blood pressure could only be effectively controlled by taking 4 or more antihypertensive drugs);
Have active bleeding within 2 months before screening or is taking anticoagulant/antiplatelet drugs, or the investigators believe that there is a clear bleeding tendency (such as esophageal varices with bleeding risk, or a locally active ulcer lesions);
Active and/or persistent autoimmune anemia and/or autoimmune thrombocytopenia requiring treatment (e.g., idiopathic thrombocytopenic purpura);
Have medical history of deep vein thrombosis or pulmonary embolism;
Have medical history of stroke or intracranial hemorrhage within 6 months before taking study drug;
Have clinically significant gastrointestinal abnormalities, which might affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
Have active infection requiring systemic anti-infective treatment;
At screening, patients with active uncontrolled infection [such as intravenous infection that requiring antibiotic therapy, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, etc.]; Note: If hepatitis B virus surface antigen (HBsAg) is positive, HBV-DNA < 1000 cop/ml, and ALT/AST ≤ 2.0 × ULN can be included. HCV infection is defined as HCV-Ab positive.
Have past history of or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc;
Have history of alcohol or drug abuse;
Have undergone major surgery or have not recovered from the invasive operation within 4 weeks before taking the study drug for the first time and are not suitable for the clinical trial according to the judgment of the investigators;
Whowill participating in other clinical studies or haveparticipated in other intervention clinical trials within 4 weeks before screening;
Pregnant or lactating women;
Concomitant administration of drugs with moderate to severe inhibition or strong induction of cytochrome P450 CYP3A;
Subjects determined by the investigators to be unsuitable for other reasons;
Cohort 3: R/R-MCL
Havepreviously received any of the following treatments:
Chemotherapy, targeted therapy, radiotherapy or antibody based anti-tumor therapy are used within the first 4 weeks or 5 half-lives (whichever is shorter) before the first administration;
Have previously received the treatment of BTK, phosphoinositide kinase 3 kinase [PI3K] or SYK inhibitors) or BCL-2 inhibitors (such as ABT-199) or Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) or received bispecific antibody drug;
Use of systemic corticosteroids at or above 20 mg/day prednisone or equivalent within 7 days before the first administration of study drug;
Have other malignant tumors within 3 years, except for the curable basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast ;
Non-hematologic toxicity of the previous anti-tumor treatment has not recovered to ≤ grade 1 (except for hair loss);
Have uncontrollable or severe cardiovascular disease, including:
Congestive heart failure with New York Heart Association (NYHA) grade II or higher, unstable angina, myocardial infarction within 6 months before first study drug administration, or arrhythmia requiring treatment during screening period, Left Ventricular Ejection Fraction (LVEF) <50% ;
Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, and atypical cardiomyopathy);
Clinically significant QTc interval prolonged medical history, or the QTc interval of screening period > 470 ms in female, and > 450 ms in male;
Uncontrollable high blood pressure (on the basis of improving life style, with 2 or more antihypertensive drugs (including diuretics) that will be reasonably tolerable and sufficient for more than one month being applied, the blood pressure has not reached to the standard yet, , or the blood pressure could only be effectively controlled by taking 4 or more antihypertensive drugs);
Have medical history of deep vein thrombosis or pulmonary embolism;
Have medical history of stroke or intracranial hemorrhage within 6 months before taking study drug;
Have clinically significant gastrointestinal abnormalities, which might affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
Have serious or active infection requiring systematic anti infection treatment;
At screening, patients with active uncontrolled infection [such as infection that requiring intravenous antibiotic therapy, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, etc.]; Note: If hepatitis B virus surface antigen (HBsAg) is positive, HBV-DNA < 1000 cop/ml, and ALT/AST≤ 2.0 × ULN can be included. HCV infection is defined as HCV-Ab positive.
Have past history of or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc;
Have history of alcohol or drug abuse;
Have undergone major surgery or have not recovered from the invasive operation within 4 weeks before taking the study drug for the first time and is not suitable for the clinical trial according to the judgment of the investigators;
Who is participating in other clinical studies or have participated in other intervention clinical trials within 4 weeks before screening;
Pregnant or lactating women;
Concomitant administration of drugs with moderate to severe inhibition or strong induction of cytochrome P450 CYP3A;
Subjects determined by the investigators to be unsuitable for other reasons;

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jin Yan, MD contact

+8618652596381

jin.yan@teligene.com

China4 sites, 4 recruiting

Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yuankai Shi, PhD, +86(010)-87788293, syuankaipumc@126.com
Yuankai Shi, phD
Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100083
Hongmei Jing, phD, +8615611908428, bysyjhm@sina.com
Recruiting
West China Hospital，Sichuan University
Chengdu, Sichuan, 610041
Liqun Zou, phD, +8618980601027, hxlcyxy@163.com
Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Fangfang Lv, MD, +8618017312613, lvff80@163.com
Dongmei Ji, phD
Recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study of Keynatinib in Relapsed/Refractory B-cell Lymphoma

Read the detailed description

This tiral adopts a multi-center, single-arm, multi-cohort, and open-label design to evaluate the efficacy and safety of keynatinib in patients with relapsed/refractory B-cell lymphoma.

There will be three cohorts in this trial, details as follows: Cohort 1: R/R-PCNSL subjects; Cohort 2: R/R-CLL/SLL subjects; Cohort 3: R/R-MCL subjects.

10-25 subjects will be enrolled in the R/R-PCNSL, R/R-CLL/SLL, and R/R-MCL cohorts, respectively.

Conditions: Lymphoma, B-Cell
Being tested: Keynatinib
Keywords: Relapsed/Refractory Primary Central Nervous System Lymphoma, Relapsed/Refractory Chronic Lymphoblastic Leukemia, Relapsed/Refractory Small Lymphocytic Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma
Medical subject headings: Lymphoma, B-Cell, Recurrence, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell

What participants receive

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

KeynatinibDrug
Also called TL007
All subjects shall be treated with Keynatinib twice a day (once every 12 hours), 20 mg each time, fasting within 2 hours before and 1 hour after taking the drug, and taking warm water when taking the drug. It is recommended to take the drug at the same time every day. In case of missed administration, the subjects should be instructed to take it as soon as possible when they think of it on the same day. If it is within 3 hours later than the scheduled administration, the study drug should be taken as soon as possible; if the interval is > 3 hours, skip this time and take the next dose at the normal scheduled time. Do not take double dose at one time. Every 28 days is a treatment cycle until the specified interview completed, PD, intolerable toxicity, death occurs or withdraw from the study (including withdrawal of informed consent by the subject or termination of the study when the investigator judges that the risk is greater than the benefit), whichever occurs first.

Study groups in NCT04807881
Study group	Role	What they receive
Keynatinib treatment group	Experimental	Keynatinib, 20 mg，BID Receives: Drug: Keynatinib

What is being measured

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

Objective Response Rate (CR+PR)
The proportion of subjects whose optimal efficacy observed from the beginning of administration is CR or PR.
Measured: Every 2 administration cycles in cycle 1-6 and every 3 administration cycles in cycle 7-n.

Timeline

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

24 Sep 202010 Apr 2028

First posted19 Mar 2021
Study start24 Sep 2020
Primary completion10 Oct 2027 (estimated)
Study completion10 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 75 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04807881
Sponsor's protocol ID: MEDO-BTK-20001
Status last verified: Jan 2025
First submitted: 18 Mar 2021
Last updated: 22 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan to make individual participant data (IPD) available to other researchers.

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Clinical Study of Keynatinib in Relapsed/Refractory B-cell Lymphoma
ClinicalTrials.gov ID: NCT04807881
Acronym / sponsor ID: MEDO-BTK-20001
Conditions: Lymphoma, B-Cell
Keywords: Relapsed/Refractory Primary Central Nervous System Lymphoma, Relapsed/Refractory Chronic Lymphoblastic Leukemia, Relapsed/Refractory Small Lymphocytic Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 75 participants (estimated)
Lead sponsor: Medolution Ltd.Industry (pharma, biotech, devices)
Study start: 24 Sep 2020 (actual)
Primary completion: 10 Oct 2027 (estimated)
Study completion: 10 Apr 2028 (estimated)
First posted: 19 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This tiral adopts a multi-center, single-arm, multi-cohort, and open-label design to evaluate the efficacy and safety of keynatinib in patients with relapsed/refractory B-cell lymphoma.

There will be three cohorts in this trial, details as follows: Cohort 1: R/R-PCNSL subjects; Cohort 2: R/R-CLL/SLL subjects; Cohort 3: R/R-MCL subjects.

10-25 subjects will be enrolled in the R/R-PCNSL, R/R-CLL/SLL, and R/R-MCL cohorts, respectively.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Keynatinib treatment group	Experimental	Drug: KeynatinibKeynatinib, 20 mg，BID

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (27 listed)

Unlimited gender, age ≥ 18 years (including critical value)-Cohort 1/2/3;
Voluntarily participate in the study and sign the ICF, follow the trial treatment protocol and interview plan-Cohort 1/2/3;
The subject's disease diagnosis meets all of the following conditions:
When screening, the status score of Eastern Cooperative Oncology Group (ECOG) is 0 to 2 points-Cohort 1/2/3;
Estimated survival time ≥ 4 months-Cohort 1/2/3;

Key exclusion criteria (82 listed)

Cohort 1: R/R-PCNSL
Cohort 2: R/R-CLL/SLL
Have medical history of prolymphocytic leukemia, known medical history of Richter syndrome or currently suspected Richter transformation (patients with clinical suspicion need biopsy to exclude transformation)
Have previously received any of the following treatments:
Use of systemic corticosteroids within 7 days before the first administration of study drug, or continuous use of prednisone at or above 20 mg/day or equivalent;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KeynatinibAlso: TL007All subjects shall be treated with Keynatinib twice a day (once every 12 hours), 20 mg each time, fasting within 2 hours before and 1 hour after taking the drug, and taking warm water when taking the drug. It is recommended to take the drug at the same time every day. In case of missed administration, the subjects should be instructed to take it as soon as possible when they think of it on the same day. If it is within 3 hours later than the scheduled administration, the study drug should be taken as soon as possible; if the interval is > 3 hours, skip this time and take the next dose at the normal scheduled time. Do not take double dose at one time. Every 28 days is a treatment cycle until the specified interview completed, PD, intolerable toxicity, death occurs or withdraw from the study (including withdrawal of informed consent by the subject or termination of the study when the investigator judges that the risk is greater than the benefit), whichever occurs first.	Drug	Keynatinib treatment group

Primary outcome

Objective Response Rate (CR+PR)
Time frame: Every 2 administration cycles in cycle 1-6 and every 3 administration cycles in cycle 7-n.
The proportion of subjects whose optimal efficacy observed from the beginning of administration is CR or PR.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.

Related trials for Lymphoma, B-Cell

Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
RecruitingPhase 2
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, B-All
RecruitingPhase 1
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jin Yan, MD contact

+8618652596381

jin.yan@teligene.com

Dawei Zhang, phD study director

Medolution Ltd.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Keynatinib in people with Lymphoma, B-Cell, run by Medolution Ltd. at 4 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 27 inclusion and 82 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Jin Yan, MD (+8618652596381, jin.yan@teligene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (CR+PR) (time frame: Every 2 administration cycles in cycle 1-6 and every 3 administration cycles in cycle 7-n.). 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 NCT04807881.

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 22 Jan 2025.