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Cyclophosphamide

Fludarabine

Fludarabine phosphate

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.

Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously.

Lymphodepletion treatment:

Drugs:Fludarabine Drugs: Cyclophosphamide

single dose of CNCT19

Hui Ding

Ningling Wang, Dr.

Xianmin Guan, Dr.

Yingyi He, Dr.

Hongsheng Zhou, Dr.

Heng Mei, Dr.

Yongjun Fang, Dr.

Kailin Xu, Dr.

Fei Li, Dr.

Xiaofan Zhu, MD

Xiaoming Liu, MD

Xiaofan Zhu, M.D

This is a multi-center, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).

This trial is a multi-center, open label, single-arm, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 in Children and Adolescent(aged 3\~18 years old) patients (pediatric) with r/r B-cell ALL.

The phase Ib part of the trial is to evaluate the safety, optimal dose of CNCT19, Pharmacokinetics/Pharmacodynamics(PK/PD)and preliminary efficacy in the treatment of Children and Adolescent patients with r/r B-cell ALL.

The phase II part of the trial is to evaluate the efficacy and safety of CNCT19 in in the treatment of Children and Adolescent patients with r/r B-cell ALL.

The study includes screening, pre-treatment (Cell Product manufacture \& lymphodepletion), CNCT19 infusion , safety and efficacy follow-up, and survival follow-up. All subjects who have received CNCT19 infusion will be followed for up to 2 years.

A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)

A Phase Ib/II, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of CNCT19 in Children and Adolescent(Pediatric) Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)

Currently the investigators have no plan of interim anaylsis, the investigators don't plan to share individual participant data(IPD) during the trial on-going.

ORR is defined as Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) per NCCN classification, as determined by Independent Review Committee (IRC)

MRD negativity status as determined using flow cytometry

The Investigators' evaluation results of ORR will be utilized in the sensitivity analysis

MRD negativity as determined using flow cytometry

The proportion of patients who have achieved the best response (CR or CRi) after CNCT19 treatment

DOR is defined as the time between their first complete response per independent review to relapse or any death in the absence of documented relapse

The proportion of patients who have received Allo-SCT after CNCT19 treatment

RFS is defined as the time from the CNCT19 infusion date to the date of disease relapse or death from any cause.

OS is defined as the time from the CNCT19 Cell Injection infusion to the date of death from any cause

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) and Severity of TEAE

Clinically significant laboratory abnormalities were defined as per investigator's discretion

To characterize the concentration of CAR-T cell in peripheral blood, bone marrow and cerebral spinal fluid (CSF, if available)by Flow Cytometry and quantitative polymerase chain reaction(qPCR).

Maximum detected concentration of CNCT19 in peripheral blood

Time to maximum concentration of CNCT19 in peripheral blood

Area under the concentration (AUC) vs time curve of CNCT19 in peripheral blood

Collected as pharmacodynamic data, including IL-6 at least

To characterize prevalence and incidence of humoral immunogenicity to CNCT19

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)	NCT05667506	B-cell Acute Ly...	single dose of ...	3 Years - 18 Years	Juventas Cell Therapy Ltd.
A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)	NCT05667506	B-cell Acute Ly...	single dose of ...	3 Years - 18 Years	Juventas Cell Therapy Ltd.

Spots Global Cancer Trial Database for cluster of differentiation antigen 19(cd19)