In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies.

0.2-60 x 10\^6 CAR T cells per kg body weight.

ThisCART19 cells

Jun Li, Ph.D

Ling He

Xingbing Wang

Jun Li

This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.

This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10\^6 cells per kg body weight.

Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies

A Study to Evaluate the Safety and Clinical Activity of Allogeneic Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.

To assess adverse events as dose limiting toxicities as defined by the protocol.

Proportion of patients in whom with morphologic complete remission (CR)

The mortality related with ThisCART19 infusion.

For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve CR or chronic lymphocytic leukemia(CRi); for chronic lymphocytic leukemia (CLL) and lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR).

Duration of Response (DOR) defined as the duration (days) from initial response to disease relapse, progression, or death due to any course.

Adverse events assessed according to NCI-CTCAE v5.0 criteria

The rate of patients whom alive at year 2

Anhui Provincial Hospital

Fundamenta Therapeutics, Ltd.

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

0.2-60 x 10\^6 CAR T cells per kg body weight

zhenyu li

Zhengyu Li, Ph.D

A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

ThisCART19 cell is a non-gene-editing allogeneic CAR-T cell targeting CD19. This study is designed to evaluate the safety and clinical activity of ThisCART19 in patients with CD19 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma

An Open and Single Dose-escalation Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD19(ThisCART19) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma (r/r B-NHL)

Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0

Anti-tumor efficacy by 2014 Lugano criteria

The interval between administration and disease progression or death

The interval between administration and death caused by any reason

EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies	NCT04384393	B Cell Malignan...	ThisCART19 cell...	3 Years - 70 Years	Fundamenta Therapeutics, Ltd.
Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma	NCT05106907	B-cell Malignan...	ThisCART19 cell...	18 Years - 70 Years	Fundamenta Therapeutics, Ltd.
Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies	NCT04384393	B Cell Malignan...	ThisCART19 cell...	3 Years - 70 Years	Fundamenta Therapeutics, Ltd.

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