Neoplasms

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Rare Diseases

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

All Drugs and Chemicals

Immunomodulating Agents

Immunologic Factors

In LCAR-L10D treatment group, patients will be treated with dual specificity CD19 and CD22 CAR-T cells with a escalation approach, 3 CAR-T dosage will be tested in this study: 0.5×10\^6, 1.5×10\^6, 5.0×10\^6 CAR-T cells/kg.

Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection.

Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy

Aili He, MD, PhD

This is a prospective, single-arm, single-center, open-label, single-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profile of LCAR-L10D in subjects with CD19- and/or CD22-positive relapsed/refractory B-cell lymphoma after prior adequate standard of care.

CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies, CD19 and CD22 are proteins usually expressed on the surface of the lymphoma cells. The dual specificity CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.

A Single-center Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-L10D Cell Formulations Targeting CD19 and CD22 in Patients With CD19- and/or CD22-Positive Relapsed/Refractory B-cell Lymphoma

Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose. An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment

Venous blood samples will be collected for measurement of CAR-T positive cellular concentration

Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LCAR-L10Dcell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per Lugano 2014 only.

Duration of Remission (DOR) is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to LUGANO 2014 ) of the responders (who achieve PR or better response).

Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-L10Dto the first documented disease progression (according to LUGANO 2014 ) or death (due to any cause), whichever occurs first.

Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-L10Dto death of the subject.

Time to Response (TTR) is defined as the time from the date of first infusion of LCAR-L10Dto the date of the first response evaluation of the subject who has met all criteria for PR or better.

Venous blood samples will be collected to measure LCAR-L10Dpositive cell concentrations and the transgenic level of LCAR-L10D, at the time points when anti-LCAR-L10D antibody serum samples are evaluated.

Nanjing Legend Biotech Co.

Second Affiliated Hospital of Xi'an Jiaotong University

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

In BLLCAR-L10D treatment group, patients will be treated with dual specificity CD19 and CD22 CAR-T cells with a escalation approach, 3 CAR-T dosage will be tested in this study: 0.5×10\^6, 1.5×10\^6, 2.0×10\^6 CAR-T cells/kg.

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia.

CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory acute B lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual specificity CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.

Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia

A Phase I Clinical Study of Dual Specificity CD19 and CD22 Chimeric Antigen Receptor T Cell Therapy in Relapsed or Refractory Acute B Lymphoblastic Leukemia

Objective response include complete remission and partial remission

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Single-center Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-L10D Cell Formulations Targeting CD19 and CD22 in Patients With CD19- and/or CD22-Positive Relapsed/Refractory B-cell Lymphoma	NCT03593109	Lymphoma, B-Cel...	Dual Specificit...	18 Years - 75 Years	Second Affiliated Hospital of Xi'an Jiaotong University
Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia	NCT04094766	Refractory B Ac... Relapse B Acute...	Dual Specificit...	14 Years - 60 Years	Second Affiliated Hospital of Xi'an Jiaotong University

Spots Global Cancer Trial Database for cd19 and cd22