Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Conditions
Interventions
Trial group:SNC116 administration
Sponsors
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years, with no gender restriction. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. 3.Histopathologically confirmed large B-cell lymphoma, follicular lymphoma grade 3b, or transformed indolent B-cell lymphoma, specifically including the following: (1) Large B-cell lymphoma includes the following subtypes as defined by the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (2022): 1)Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); 2)T-cell/histiocyte-rich large B-cell lymphoma; 3)Diffuse large B-cell lymphoma/high-grade B-cell lymphoma with MYC and BCL2 rearrangements; 4)ALK-positive large B-cell lymphoma; 5)Large B-cell lymphoma with IRF4 rearrangement; 6)High-grade B-cell lymphoma with 11q aberration; 7)Lymphomatoid granulomatosis; 8)EBV-positive DLBCL, not otherwise specified (NOS); 9)Primary large B-cell lymphoma of immune-privileged sites (eligible if assessed appropriate by the investigator, except primary central nervous system lymphoma); 10)Primary cutaneous diffuse large B-cell lymphoma, leg type; Intravascular large B-cell lymphoma; 11)Primary mediastinal large B-cell lymphoma; 12)High-grade B-cell lymphoma, not otherwise specified; (2) Follicular lymphoma grade 3b; (3) Large B-cell lymphoma transformed from indolent B-cell lymphoma (including but not limited to DLBCL transformed from follicular lymphoma or marginal zone lymphoma, and Richter transformation of CLL/SLL). 4.Must have received at least 2 prior lines of systemic anti-B-cell lymphoma therapy. Subjects must have received at least one course of anthracycline-based chemotherapy (except in cases of absolute contraindication due to cardiac dysfunction) and at least one course of anti-CD20 immunotherapy (except for CD20-negative subjects or those with contraindication due to severe toxicity): (1)Induction + consolidation +/- transplantation +/- maintenance therapy is counted as 1 line of systemic treatment; (2)Anti-CD20 monotherapy is not counted as 1 line of systemic treatment; (3)Local radiotherapy is not counted as 1 line of systemic treatment. 5.Subjects with prior CD19-targeted therapy (including monoclonal antibodies, bispecific antibodies, CAR-T therapy, investigational therapy, etc.) must provide a histopathological report at screening to confirm persistent CD19 expression in lymphoma tissue after the last CD19-targeted therapy. 6.Imaging evidence of relapsed or refractory disease at enrollment: (1)Relapse is defined as: achievement of partial response (PR) or better with the last-line therapy, followed by disease progression (excluding cases meeting the definition of refractory disease); (2)Refractory disease is defined as: failure to achieve partial response (PR) or better with the last-line therapy, or relapse within 6 months after the last treatment regimen, or relapse within 12 months after autologous hematopoietic stem cell transplantation (ASCT). (If salvage therapy is administered after ASCT, the subject must have a response of 1.5 cm; extranodal lesions with an LD > 1.0 cm. (1)Lesions previously treated with radiotherapy are considered measurable only if there is clear evidence of disease progression after completion of radiotherapy. 8.Expected survival
Exclusion criteria
Exclusion criteria: 1.Subjects with a known history of allergy, hypersensitivity, intolerance, or contraindication to any component of SNC116 or drugs that may be used in the study (e.g., tocilizumab), or those who have experienced a severe allergic reaction in the past. 2.Subjects with primary central nervous system (CNS) lymphoma or active CNS involvement, except: Subjects with a history of CNS involvement whose condition is assessed by the investigator as stable after treatment may be enrolled in the study. 3.Subjects with a history of grade >=3 gastrointestinal bleeding within 1 month prior to screening, or those assessed by the investigator as having a risk of grade >=3 gastrointestinal bleeding (per CTCAE, Version 5.0). 4.Subjects with a history of allogeneic hematopoietic stem cell transplantation or gene therapy. 5.Subjects who have received the following drugs/treatments prior to SNC116 administration: (1) Small-molecule targeted therapy within 1 week or 3 half-lives (whichever is deemed appropriate by the investigator); (2) Therapeutic doses of corticosteroids (prednisone > 20 mg/day or equivalent dose of other steroids) within 1 week, except: Topical application or use for preventing allergic reactions; (3) Prophylactic treatment with short-acting oral antiretroviral drugs within 1 week. Use of long-acting antiretroviral prophylactic drugs is not allowed within 2 years of receiving SNC116 treatment; (4) Local palliative radiotherapy within 2 weeks; (5) Traditional Chinese Medicine (TCM) with anti-tumor indications within 2 weeks; (6) Macromolecular drug therapy within 3 weeks; (7) Cytotoxic therapy within 3 weeks; (8) Investigational drugs/treatments (except those in a well-defined placebo-controlled group) within 3 weeks; (9) Major surgery within 3 weeks; (10) Live vaccine vaccination within 3 weeks; (11) Immunosuppressant treatment within 3 weeks; (12) Autologous hematopoietic stem cell transplantation, CAR-T cell therapy, or CAR-NK cell therapy within 3 months. 6.At screening, any adverse event (AE) related to previous anti-lymphoma treatment that has not resolved to grade = Grade 3; (6) Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) or hypertension
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The best overall response rate (ORR);The 3-month overall response rate (ORR);The complete response rate (CRR);The duration of response (DOR);The Progression-Free Survival (PFS);The Overall Survival (OS);SNC116 Particles After Administration;The maximum concentration of CD19 CAR-T cell count and gene copy number expansion;The time to reach the maximum concentration;Area Under the Concentration-Time Curve;The last detectable concentration point;The time of the last detectable concentration;The dynamic changes of pharmacodynamics indicators such as cytokines in the peripheral blood of subjects after administration; | — |
Primary
| Measure | Time frame |
|---|---|
| Safety (All adverse events, the incidence, nature and severity of serious adverse events, as well as abnormal laboratory test results, etc.);Incidence of DLT; | — |
Countries
China
Contacts
Public ContactLi Ning
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed