An interventional study of Cellular Therapy in Precise Design of Cell Therapy for Relapsed and Refractory Hematological Tumors and Hematologic Disease, sponsored by Ruijin Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
This clinical trial aims to evaluate the efficacy and safety of CAR-T cell therapy in patients with relapsed/refractory hematologic malignancies.
This clinical trial aims to evaluate the efficacy and safety of CAR-T cell therapy in patients with relapsed/refractory hematologic malignancies. The primary objective is to determine the maximum tolerated dose (MTD), safety profile, and the overall response rate (ORR) of CAR-T cells in these patients. Secondary objectives include assessing marrow remission rates and minimal residual disease (MRD) clearance at various time points (2 weeks, 1 month, 3 months, 6 months, and 1 year) in patients with bone marrow involvement, as well as evaluating the changes in multiple sites of involvement through PET-CT or PET-MRI before and one year after CAR-T therapy. The study will also track event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) rates at 1, 2, 3, and 5 years post-treatment.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's planned enrollment of 200 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
The drug for this trial is Precise Designof CAR- cells transduced with the lentiviral vector . The dose is 2x10e6 \~1x10e7 CAR-cell/kg in patients with relapsed/refractory hematologic malignancies.
Drug: 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.
adverse events.
Type, incidence and severity of adverse events
Time frame: 1 month
Maximum tolerated dose
The maximum dose that does not cause death of the subject
Time frame: 1 month
Overall response rate
ORR in patients is defined as the rate of complete remission (CR, CRh)
Time frame: 3 months
Overall incidence and severity of adverse events.
Overall incidence and severity of adverse events will measure in this trial.
Time frame: 12 months
Rate of relapse and refractory of Hematologic Diseases patients achieving MRD negative CR
The rate of relapse and refractory of Hematologic Diseases patients achieving MRD negative CR in D28; 3,6,12months.
Time frame: 12 months
Level of circulating CAR T cells
To investigate the relationship between the dynamic changes of CAR-T cells in the peripheral blood and treatment outcomes, as detected by FCM and/or real-time quantitative PCR technology
Time frame: 12 months
Plan to share: No
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This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital