Relapsed/refractory peripheral T-cell lymphoma and NK/T-cell lymphoma
Conditions
Interventions
Group 1:400mg CN401 tablet
Group 2:600mg CN401 tablet
Group 3:800mg CN401 tablet
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 75 years (inclusive), no gender limit. 2. Phase I of this study includes patients with R/R PTCL, R/R cutaneous T-cell lymphoma (CTCL) and R/R non-Hodgkin's B-cell lymphoma (B-NHL); Stage II includes patients with R/R PTCL. (1) R/R TCL patients must meet the pathological subtypes of the 2016 World Health Organization (WHO) lymphoma classification, including but not limited to peripheral T-cell lymphoma not specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), mycosis fungoides or Sezary syndrome. (2) R/R B-NHL patients must meet the following WHO diagnostic subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) (grade I-III), marginal zone lymphoma , lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), small lymphocytic lymphoma, and transformed large B-cell lymphoma. (3) Relapse is defined as PD (progression at the primary site or new onset at other sites) after adequate treatment to achieve CR or partial remission (PR). Note: DLBCL patients require at least second-line therapy to relapse; other patients require at least first-line therapy to relapse. (4) Refractory is defined as no response to standard therapy, and the best response to standard therapy is PD or stable disease (SD); patients are not suitable for autologous hematopoietic stem cell transplantation (ASCT) or PD after ASCT. 3. According to Lugano 2014 assessment criteria, patients must have measurable lesions, defined as at least 1 nodular lesion > 1.5 cm in longest diameter, or at least 1 extranodal lesion > 1 cm in longest dimension and at least 2 accurately measurable vertical diameters. 4. Patients with Eastern Cooperative Oncology Group (ECOG) physical fitness score = 1.5x10^9/L, growth factor support should not be used within 7 days before the test; (2) PLT count >= 75x10^9/L, growth factor support or blood transfusion should not be used within 7 days before the test; (3) Hemoglobin > 8.0 g/dL, no blood transfusion within 7 days before the test. 6. Patients with basically normal coagulation function: activated partial thromboplastin time (APTT) = 50 mL/min (according to the calculation standard of the actual measurement center); (3) Echocardiography: Left ventricular ejection fraction (LVEF) >= 50%, no clinically significant pericardial effusion. 8. Patients must give informed consent to this study before the trial and voluntarily sign a written ICF. 9. Female patients of childbearing age must have a negative blood pregnancy test within 14 days before the first use of the investigational drug; Patients of childbearing potential must agree to use reliable contraception (hormonal or barrier method or abstinence) with their partner from signing the ICF to 90 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Patients who have received PI3K inhibitor treatment or mTOR/SYK inhibitor before using the investigational drug for the first time. 2. Patients who received ASCT within 100 days before the first use of the investigational drug, or patients who have received allogeneic stem cell transplantation. 3. Patients with current acute graft-versus-host disease (GVHD) or active chronic GVHD. 4. Received anti-tumor treatment (such as chemotherapy, radiotherapy, immunotherapy, biological therapy, hormone therapy, etc.) within 28 days before the first use of the investigational drug, except for the following cases: (1) Receive palliative radiotherapy within 14 days before the first use of the investigational drug; (2) Patients who have used immunomodulatory drugs, including but not limited to thymosin, interleukin-2 (IL-2), interferon (IFN), and traditional Chinese medicines with anti-tumor indications within 14 days before the first use of the investigational drug; (3) Patients who have received systemic glucocorticoid (prednisone >= 20 mg/day or equivalent dose of similar drugs) or other immunosuppressive therapy within 14 days before the first use of the investigational drug; Except for the following cases: treatment with topical, ocular, intra-articular, intranasal and inhaled glucocorticoids, short-term use of glucocorticoids for prophylaxis (eg, prevention of contrast medium allergy); (4) Strong inducers or inhibitors of cytochrome CYP3A4, CYP3A5 or CYP2C9 have been used within 7 days or 5 half-lives (whichever is longer) before the first use of the investigational drug. 5. Received other clinical trial drugs within 28 days before the first use of the test drug. 6. Patients who have undergone major organ surgery (excluding needle biopsy) or significant trauma within 28 days before the first use of the investigational drug, or require elective surgery during the trial. 7. Patients who have used live attenuated vaccines within 28 days before the first use of the investigational drug. 8. Patients with central nervous system (CNS) involvement. 9. Patients with previous or concomitant CNS diseases, including: epilepsy, hemorrhagic/ischemic stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, occurred within 6 months before the first administration of the investigational drug, organic brain syndrome, mental illness, etc. 10. There is a history of other active malignant diseases within 2 years before entering the study, but the following conditions are allowed to enter the group: fully treated cervical carcinoma in situ, local skin basal cell carcinoma or squamous cell carcinoma, previous malignancy that was controlled and treated with local curative treatment (surgery or other). 11. Patients with active infection who currently require intravenous systemic anti-infective therapy. 12. The following serological states suggestive of active hepatitis B or C virus infection: (1) Hepatitis B surface antigen (HBsAg) positive. For patients with hepatitis B core antibody (HBcAb) positive but HBsAg negative, enrollment was possible if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was undetectable (<200 IU/mL) and willing to undergo monthly hepatitis B virus (HBV) reactivation monitoring; (2) Hepatitis C virus (HCV) antibody positive. Patients with HCV antibodies were eligible if HCV ribonucleic acid (RNA) was undetectable. 13. Patients with a history of immunodeficiency, including a positive human immunodefi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Tolerance;Objective response rate; | — |
Countries
China
Contacts
Public ContactSong Yuqin
Beijing Cancer Hospital
Outcome results
None listed