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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

Juventas Cell Therapy Ltd.

Lymphoma, Non-Hodgkin

Dose A: 1.00 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Dose B: 2.00 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Dose C: 4.00 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Dehui Zou, Dr.

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.

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.

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

Determine the MTD and DLT of CNCT19 in the Treatment and recommend the dose for Phase II study.

Safety measures include adverse events as assessed by CTCAE v5.0.

Efficacy of CNCT19 as measured by ORR during the 3 months after CNCT19 infusion, which includes CR and PR.

Efficacy of CNCT19 as measured by ORR during the 28 days after CNCT19 infusion, which includes CR and PR.

Efficacy of CNCT19 as measured by ORR during the 2 months after CNCT19 infusion, which includes CR and PR.

Efficacy of CNCT19 as measured by ORR during the 6 months after CNCT19 infusion, which includes CR and PR.

The best overall response after CNCT19 infusion.

TTR is defined as the time from the CNCT19 infusion to the first documented CR or PR.

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.

DOR is defined as the time from the first documented CR or PR to the date of the first documented relapse or PD.

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.

Dose: 2.00 x 10\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Yan Zhou

Kai Hu, Dr.

Yuqin Song, Dr.

Hongmei Jing, Dr.

Lin Liu, Dr.

Li Gao, Dr.

Wenyu Li, Dr.

Huiqing Huang, Dr.

Keshu Zhou, Dr.

Mingzhi Zhang, Dr.

Liang Huang, Dr.

Chunyan Ji, Dr.

Weili Zhao, Dr.

Aibin Liang, Dr.

Ting Niu, Dr.

Lanfang Li, Dr.

Jie Jin, Dr.

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of relapsed or refractory NHL.

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of relapsed or refractory NHL. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period (2 years at most).

Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Efficacy of CNCT19 as measured by ORR at the 3 months after CNCT19 Cell Injection infusion, which includes CR and PR.

Efficacy of CNCT19 as measured by CR during the 3 months after CNCT19 Cell Injection infusion.

PFS means duration from the CNCT19 Cell Injection infusion to progression of lymphoma, or death for any reason.

DFS means duration from the beginning of complete remission to relapse of disease, or death (for any reason).

DOR means the duration from reaching the response (e.g., CR or PR) criteria of the therapy to the first, clearly defined progressive disease, or death for disease under investigation.

OS means duration from the CNCT19 Cell Injection infusion to death for any reason, or the last follow-up for survival.

TTR means duration from the CNCT19 Cell Injection infusion to the first response (irrespective of PR or CR, which comes first).

Dose: 0.5 x 10\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Chunrong Tong

Xi Zhang

Hongsheng Zhou

Min Jiang

Xudong Wei

Heng Mei

Kailin Xu

Aibin Liang

Ting Niu

Jianxiang Wang, Dr.

Jie Jin

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period (2 years at most).

Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase Ⅱ Clinical Trial of CNCT19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia

The Investigators' evaluation results of ORR will be subjected to sensitivity analysis.

MRD negative status as determined using flow cytometry.

The proportion of patients who have achieved CR or CRi.

RFS means the duration from reaching the response CR or CRi to the first defined relapse, or death due to any cause, whichever comes first.

EFS means duration from the CNCT19 Cell Injection infusion to death for any reason after remission, relapse, treatment failure, no response, or termination (because of death, adverse event, lack of efficacy, progression, new anti-tumor treatments.

DOR means the duration from reaching the response CR or CRi to the first defined relapse, or death due to any cause, whichever comes first.

The proportion of patients who have achieved the best effect (CR or CRi) after the experimental treatment.

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

Characterize the pharmacokinetic (PK) profile in blood, bone marrow (if available) and Cerebral Spinal Fluid (CSF) (if available) by qPCR.

Characterize the pharmacokinetic (PK) profile in blood, bone marrow (if available) and Cerebral Spinal Fluid (CSF) (if available) by Flow Cytometry.

Collected as pharmacodynamic data, including IL-6 at list.

Dose A: 0.25 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Dose B: 1.00 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Dose C: 2.00 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

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 acute lymphoblastic leukemia.

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 acute lymphoblastic leukemia. 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.

A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia

Efficacy of CNCT19 as measured by ORR during the 3 months after CNCT19 infusion, which includes CR and CRi.

MRD negative status as determined by central laboratory using multi-parameter flow cytometry.

DOR is defined as the time from the first documented CR or Partial Remission (PR) to the date of the first documented progressive disease(PD) or death due to any cause.

RFS is defined as the time from the documented CR or PR after the CNCT19 infusion to the date of the documented PD or death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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 Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Diffuse Non-Hodgkin Lymphoma	NCT04232826	Diffuse Non-Hod...	single dose of ...	18 Years - 70 Years	Juventas Cell Therapy Ltd.
Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma	NCT04586478	Non-Hodgkin's L...	single dose of ...	18 Years - 75 Years	Juventas Cell Therapy Ltd.
Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia	NCT04684147	Relapsed or Ref...	single dose of ...	18 Years - 65 Years	Juventas Cell Therapy Ltd.
A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia	NCT04230473	Relapsed or Ref...	single dose of ...	18 Years - 65 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.
A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Diffuse Non-Hodgkin Lymphoma	NCT04232826	Diffuse Non-Hod...	single dose of ...	18 Years - 70 Years	Juventas Cell Therapy Ltd.

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