NCT04690192

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

CNCT19 Following Autologous Stem Cell Transplantation in Patients With Relapsed or Refractory Aggressive B-cell Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Large B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CNCT19	2×10\^6/kg, infused in a single-dose on day +2, +3 or +4 following stem-cell infusion
DRUG	Gemcitabine Injection	600mg/m2/h, infused for 3 hours with loading bolus of 75mg/m2, day -7, -3,
DRUG	busulfan	105mg/m2, day -7 until -5,
DRUG	Melphalan Injection	60mg/m2, day -3, -2

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2020-12-30
• Last updated: 2025-05-13

Locations

1 site across 1 country: China