Precise Design of Cell Therapy for Relapsed and Refractory Hematological TumorsHematologic Disease
Investigational drug(s) / intervention(s)
Cellular Therapy
Cellular Therapy: This intervention involves the infusion of autologous or allogeneic CAR-T cells into patients with relapsed/refractory hematologic malignancies. CAR-T cells are modified to target specific antigens on the surface of cancerous cells. After the infusion, patients will be monitored for response and safety.
Administration: Intravenous infusion. Dosage: The maximum tolerated dose (MTD) will be determined as part of the study, with dose escalation used to identify the optimal and safest dose of CAR-T cells for treatment.
Study summary
This clinical trial aims to evaluate the efficacy and safety of CAR-T cell therapy in patients with relapsed/refractory hematologic malignancies.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
Patients with relapsed/refractory hematologic malignancies confirmed to express CD19, CD22, CD20, CD7, CD5, CD2, CD79b, BCMA, GPCR5D, CD38, CD33, CD123, CD133, CLL1, EBV (GP350, LMP1), CMV (Gb21, gB280…) or other validated targets (supported by domestic and international preclinical/clinical evidence) who meet the following criteria:
Male or female, aged ≥18 years and \<75 years; Newly diagnosed patients with refractory disease (as defined by respective diagnostic criteria) after chemotherapy; Newly diagnosed patients with disease progression during chemotherapy and poor anticipated response to further chemotherapy; Patients with relapsed disease (≥1 recurrence) and confirmed residual tumor evidence; Patients with relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT); Patients with relapse after CAR-T therapy; Patients with hematologic malignancies deemed incurable by current surgical, radiotherapy, or chemotherapy interventions.
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded:
Life expectancy \<12 weeks; Genetic testing reveals mutations or structural variants associated with the target antigens; Severe graft-versus-host disease (GVHD) requiring immunosuppressive therapy in post-HSCT relapse patients; Post-HSCT relapse \<3 months with no available donor;
Organ dysfunction:
Serum creatinine \>2.5 mg/dL; ALT/AST \>5× upper limit of normal (ULN); Total bilirubin \>2 mg/dL; Uncontrolled active infection; Active hepatitis B/C or HIV infection; Anticipated early loss to follow-up (\<3 months post-treatment); Failure to provide signed informed consent or lack of ethics committee approval; Concurrent systemic conditions that may interfere with study participation; Other exclusion criteria deemed appropriate by the investigator.
Primary outcome measure(s)
adverse events. — 1 month Type, incidence and severity of adverse events
Maximum tolerated dose — 1 month The maximum dose that does not cause death of the subject
Overall response rate — 3 months ORR in patients is defined as the rate of complete remission (CR, CRh)
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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