A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Diffuse Non-Hodgkin Lymphoma

Phase 1

Completed

• Conditions: Diffuse Non-Hodgkin Lymphoma
• Interventions: Biological: single dose of CNCT19

• Registration Number: NCT04232826
• Lead Sponsor: Juventas Cell Therapy Ltd.

Brief Summary

This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of CNCT19 in adult patients with relapsed or refractory diffuse Non-Hodgkin lymphoma.

Detailed Description

This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of CNCT19 in adult patients with relapsed or refractory diffuse Non-Hodgkin lymphoma. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CNCT19 cell infusion.

Study Timeline

• Study First Submitted: 2020-01-11
• Study Start: 2020-01-15
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-18
• Primary Completion: 2021-01-01
• Study Completion: 2022-11-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single dose of CNCT19	single dose of CNCT19	A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.

Primary Outcome Measures

Name	Time	Method
Safety of CNCT19 therapy: CTCAE v5.0	24 months	Safety measures include adverse events as assessed by CTCAE v5.0.
Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D)	28 days	Determine the MTD and DLT of CNCT19 in the Treatment and recommend the dose for Phase II study.

Secondary Outcome Measures

Name	Time	Method
Time to initial Response (TTR)	6 months	TTR is defined as the time from the CNCT19 infusion to the first documented CR or PR.
Best Overall Response (BOR)	24 months	The best overall response after CNCT19 infusion.
Progression-free survival (RFS)	24 months	PFS is defined as the time from the signing of informed consent form to the date of the documented progressive disease(PD) or death due to any cause.
Duration of remission (DOR)	24 months	DOR is defined as the time from the first documented CR or PR to the date of the first documented relapse or PD.
Overall survival (OS)	24 months	OS is defined as the time from the signing of informed consent form to the date of the last survival follow-up or death due to any cause.
Overall Remission Rate (ORR), which includes Complete Remission (CR) and Partial Remission (PR)	6 months	Efficacy of CNCT19 as measured by ORR during the 6 months after CNCT19 infusion, which includes CR and PR.

Trial Locations

Locations (2)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China