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

NCT04690192 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-13

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Juventas Cell Therapy Ltd.

    collaborator INDUSTRY

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Dehui Zou, Dr. · Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-30
Completion
2024-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04690192 on ClinicalTrials.gov