Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

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.

Behaviors and Mental Disorders

Lymphoma, B-Cell

Aggression

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Gemcitabine

Melphalan

Busulfan

Antimetabolites

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Participants will receive high-dose chemotherapy followed by stem-cell reinfusion, and a fixed dose of CNCT19 (2×10\^6/kg) will be infused in a single-dose on day +2, +3 or +4.

2×10\^6/kg, infused in a single-dose on day +2, +3 or +4 following stem-cell infusion

CNCT19

600mg/m2/h, infused for 3 hours with loading bolus of 75mg/m2, day -7, -3,

Gemcitabine Injection

busulfan

Melphalan Injection

Dehui Zou, Dr.

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.

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.

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

IPD that underlie results in a publication

Complete Response rate is defined as the incidence of a CR per the Lugano Classification (Cheson et al, 2014), as determined by study investigators.

ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators.

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

DOR is defined only for participants who experience an objective response after CNCT19 infusion and is the time from the first objective response to disease progression or death from any cause.

DFS is defined only for participants who achieve complete response after CNCT19 infusion and is the time from complete response to disease progression or death from any cause.

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

Zou Dehui

Principal Investigator

Hematologic Neoplasms

0.5 to 4 x 10\^6 autologous CNCT19 transduced cells per kg body weight, with a maximum dose of 4 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion.

Chuanli Zhao, Dr.

Chunyan Ji, Dr.

This is a single arm, open-label, single center study to determine the safety and efficacy of CNCT19 in adult patients with Relapsed or Refractory B cell Malignancies.

This is a single arm, open-label, single-center study to determine the safety and efficacy of CNCT19 in adult patients with r/r B cell Malignancies. 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 Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Injection (CNCT19) in the Treatment of Cluster of Differentiation 19 (CD19) Positive Relapsed or Refractory B Cell Malignancies

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.
CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma	NCT04690192	Large B-cell Ly...	CNCT19 Gemcitabine Inj... busulfan Melphalan Injec...	18 Years - 65 Years	Institute of Hematology & Blood Diseases Hospital, China
A Clinical Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Injection (CNCT19) in the Treatment of Cluster of Differentiation 19 (CD19) Positive Relapsed or Refractory B Cell Malignancies	NCT04011293	Relapsed or Ref...	CNCT19	18 Years -	Shandong University
CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma	NCT04690192	Large B-cell Ly...	CNCT19 Gemcitabine Inj... busulfan Melphalan Injec...	18 Years - 65 Years	Institute of Hematology & Blood Diseases Hospital, China
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 cnct19

Every month we try and update this database with for cnct19 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cnct19

Every month we try and update this database with for cnct19 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cnct19 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.