Relapsed or Refractory B-Cell Lineage Tumors
Conditions
Interventions
Dose C group:Infusion of V2502 at 0.4×10^9 TU
Dose B group:Infusion of V2502 at 0.3×10^9 TU
Dose A group:Infusion of V2502 at 0.2×10^9 TU
Sponsors
The First People’s Hospital of Jingzhou
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients meeting the following diagnostic and treatment criteria during screening: Refractory/relapsed B-cell lineage tumors (meeting one of the first five criteria below plus items 6-7): (1) Initial treatment resistance: such as CLL, certain subtypes of B-NHL, multiple myeloma; after four courses of standard first-line treatment, the disease has not achieved partial remission (tumor burden reduction =10 is considered BCMA-positive; 2) For nTPM values between 5 and 10, further confirmation is required using other detection methods (e.g., protein expression analysis or flow cytometry); (7) Biopsy requirements for relapsed patients: For patients who relapse after receiving BCMA-targeted therapy, re-biopsy (tissue or peripheral blood sample) is required to confirm BCMA expression. 2. Age between 18 and 75, gender is not restricted. 3. Measurable lesions during screening: (1) B-NHL: the long diameter of nodal lesions should be at least greater than 1.5 cm, and extranodal lesions greater than 1.0 cm (see Appendix 1: Revised Response Criteria for Malignant Lymphoma (2014)); (2) Multiple Myeloma (MM), meeting at least one of the following conditions: 1) serum M-protein level >=0.5 g/dL (>=5 g/L); 2) or urine M-protein level >=200 mg/24h; 3) or light chain MM with non-measurable disease in serum or urine: involved serum immunoglobulin free light chain >=10 mg/dL (100 mg/L) and abnormal serum immunoglobulin ?/? free light chain ratio; (3) Plasma Cell Leukemia (PCL): peripheral blood absolute plasma cell count >2×10^9/L or percentage >5%; (4) Other B-cell lineage malignancies: must meet measurable lesion criteria specific to the corresponding disease (refer to guidelines such as NCCN, IMWG, iwCLL), including but not limited to pathological cell counts in peripheral blood, proportion of bone marrow infiltration, or size and metabolic activity of imaging lesions (e.g., PET-CT or CT). 4. Have adequate bone marrow reserve at screening, defined as meeting all of the following criteria: (1) absolute neutrophil count (ANC) > 0.6×10^9/L; (2) absolute CD3+ T cell count (ALC) >= 0.15×10^9/L; (3) platelets (PLT) >= 50×10^9/L. 5. Major organ functions are basically normal: (1) Liver function: 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60 mL/min (Cockcroft and Gault formula); (3) Pulmonary function: 1) Grade 91%; 2) No clinically
Exclusion criteria
Exclusion criteria: 1. Patients with clinically significant central nervous system disorders prior to screening, such as epilepsy, cerebral ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndrome, psychiatric disorders, or any autoimmune disease involving the central nervous system. 2. Subjects with other malignancies (excluding those who have been cured and have had no active disease for more than 2 years prior to screening, as well as patients with non-melanoma skin cancer, basal cell or squamous epithelial cell skin cancer, localized prostate cancer, ductal carcinoma in situ, papillary or follicular thyroid cancer, and carcinoma in situ). 3. Subjects who meet any of the following conditions during screening: (1) positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); (2) positive for hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab), and HBV-DNA copy number exceeds the lower limit of measurement; (3) positive for hepatitis C virus antibody (HCV-Ab); (4) positive for both anti-treponema pallidum antibody (TP-Ab) and TRUST; (5) positive for HIV antibody test. 4. Presence of uncontrolled active infection. Subjects with clinical emergencies requiring urgent intervention due to tumor obstruction or compression (e.g., intestinal obstruction or vascular compression) during screening. 5. Patients with active bleeding during screening. 6. Exclude individuals with a history of deep vein thrombosis or pulmonary embolism within the past 6 months. 7. Patients who have received any of the following medications or treatments within the specified time period before infusion: (1) Lymphocyte cytotoxic chemotherapy (except for >3 t1/2) within 1 week prior to infusion; (2) Non-lymphocyte cytotoxic chemotherapy drugs (except for >3 t1/2) within 3 days prior to infusion; (3) Targeted therapy, epigenetic therapy, other investigational drug treatments, or therapies using invasive investigational medical devices that may affect efficacy evaluation (including anti-tumor treatments) within 5 half-lives; (4) Immune/non-immune targeted systemic treatment within one week; (5) Received radiotherapy within 4 weeks prior to infusion, except for patients with disease progression (PD) during or after radiotherapy; (6) History of allogeneic hematopoietic stem cell transplantation within 4 weeks prior to infusion, with acute graft-versus-host disease (GvHD) or moderate to severe chronic grade 2–4 GvHD requiring systemic medication treatment (such as hormones or other immunosuppressants); (7) Undergone surgery within 2 weeks prior to drug administration or planned surgery within 2 weeks after drug administration, excluding surgeries performed under local anesthesia; (8) Received donor lymphocyte infusion (DLI) within 4 weeks prior to infusion; (9) Received live/attenuated live vaccines within 4 weeks prior to infusion or planning to receive such vaccines during the study period; (10) Previously received treatment with vesicular stomatitis virus G (VSVG) pseudotyped virus. 8. Any participant with a known allergy, hypersensitivity, intolerance, or contraindication to any component of V2502 and its formulation ingredients, or drugs that may be used during the study (including tocilizumab, albumin, etc.), or who has a history of severe allergic reactions. 9. Clinically significant primary immunodeficiency. 10. Individuals assessed by the inves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate (ORR) and complete response rate (CRR);Pharmacodynamic (PD) Evaluation;Pharmacokinetic (PK) Evaluation; | — |
Countries
China
Contacts
Public ContactTan Jie
The First People’s Hospital of Jingzhou
Outcome results
None listed