Status:
COMPLETED
CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Juventas Cell Therapy Ltd.
Conditions:
Large B-cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this study is to explore the safety and efficacy of CNCT19 (a second-generation anti-CD19 CAR T-cell using 4-1BB as co-stimulatory domain provided by Juventas, Tianjin, China)...
Detailed Description
This is a single-center, non-randomized, open-label, prospective clinical trial to evaluate the safety and efficacy of CNCT19 infusion following high-dose chemotherapy and autologous stem-cell transpl...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed large B-cell lymphoma including the following types
- diffuse large B-cell lymphoma
- high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement
- transformed lymphoma
- Relapsed or refractory diseases fulfilling one of the following criteria (individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen)
- Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy
- Stable disease (SD) as best response after at least 4 cycles of first-line therapy
- Partial response (PR) as best response after at least 6 cycles of first-line therapy (biopsy-proven residual disease is needed for individuals with Deauville score of 4)
- PR as best response after at least 2 cycles of second-line therapy
- Disease relapse ≤12 months after the completion of first-line immunochemotherapy
- Relapsed or refractory disease after ≥2 lines of chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow function as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1000/uL
- Platelet count≥ 75,000/uL
- Adequate renal and hepatic function defined as:
- Serum alanine aminotransferase (ALT/AST) ≤ 3 upper limit of normal (ULN)
- Total bilirubin ≤1.5 mg/dL, except in individuals with Gilbert's syndrome
- Serum creatinine ≤2 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 40 mL/min
- Cardiac ejection fraction ≥ 50%
- Baseline oxygen saturation \> 92% on room air
- Life expectancy ≥3 months
- Key
Exclusion
- Active Central Nervous System (CNS) involvement by lymphoma
- History of autologous or allogeneic stem cell transplantation
- Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for at least 12 months after CNCT19 infusion.
- Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.
- History of seizure or other CNS disorder
- History of HIV infection
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04690192
Start Date
January 1 2021
End Date
December 30 2024
Last Update
May 13 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020