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.

NCT03593109

Conditions

1. Lymphoma, B-Cell

Interventions

1. Drug: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy

MeSH:Lymphoma Lymphoma, B-Cell

HPO:B-cell lymphoma Lymphoma

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. --- L10D ---

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 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. --- L10D ---

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 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. --- L10D --- --- L10D ---

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.. Incidence of anti-LCAR-L10D antibody and positive sample titer. --- L10D ---

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.. Inclusion Criteria: 1. Volunteer to participate in the clinical study; fully understand and be informed of the information on this study, and sign the written Informed Consent Form (ICF); willing to follow and able to complete all trial procedures. --- L10D ---

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.. Inclusion Criteria: 1. Volunteer to participate in the clinical study; fully understand and be informed of the information on this study, and sign the written Informed Consent Form (ICF); willing to follow and able to complete all trial procedures. --- L10D --- --- L10D ---

Women of childbearing potential must comply with the following requirements: - Subjects must agree to use a highly effective method of contraception (annual failure rate < 1% for continuous and correct use) and agree to use a highly effective method of contraception from signing the informed consent form (ICF) until at least 1 year after receiving infusion of LCAR-L10D cell formulation. --- L10D ---

condoms plus spermicidal foam/gel/film/emulsion/suppository) upon sexual intercourse with a woman of childbearing potential from signing the ICF to at least 1 year after receiving infusion of the LCAR-L10D cell formulation. --- L10D ---

- Use condoms when having sex with a pregnant woman Women and men must agree not to donate ova (oocytes, oocytes) or sperm during the study and within 1 year after infusion of LCAR-L10D cell formulation. --- L10D ---

Known life threatening allergic reactions, hypersensitivity reactions, or intolerance to LCAR-L10D cell formulation or their excipients, including DMSO (see Investigator's Brochure). --- L10D ---