CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    20
  • sponsor
    Zou Dehui
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Updated on 23 March 2022
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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) infusion following ASCT in patients with relapsed or refractory B-cell lymphoma.

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 transplantation (HDT/ASCT) in patients with relapsed or refractory B-cell lymphoma. CNCT19 cells will be infused on day +3 (±1d) with a fixed dose of 2×10^6/kg. The study will assess the safety and efficacy of this combinational therapy, including the incidence and severity of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematological, and other non-hematological toxicities, and objective response rates and complete response rates and survivals of the subjects.

Details
Condition Large B-cell Lymphoma
Treatment busulfan, Gemcitabine Injection, CNCT19, Melphalan Injection, Melphalan Injection
Clinical Study IdentifierNCT04690192
SponsorZou Dehui
Last Modified on23 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy
must have received anti-CD20 monoclonal antibody and anthracycline-containing
Stable disease (SD) as best response after at least 4 cycles of first-line therapy
chemotherapy regimen)
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Disease relapse ≤12 months after the completion of first-line immunochemotherapy
Relapsed or refractory disease after ≥2 lines of chemotherapy
Adequate bone marrow function as evidenced by
Absolute neutrophil count (ANC) ≥ 1000/uL
Adequate renal and hepatic function defined as
Platelet count≥ 75,000/uL
Serum alanine aminotransferase (ALT/AST) ≤ 3 upper limit of normal (ULN)
Total bilirubin ≤1.5 mg/dL, except in individuals with Gilbert's syndrome
Baseline oxygen saturation > 92% on room air
Serum creatinine ≤2 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 40 mL/min
Cardiac ejection fraction ≥ 50%
Life expectancy ≥3 months

Exclusion Criteria

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
History of seizure or other CNS disorder
History of HIV infection
Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease
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