SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation L10D

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 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.

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 ---

Primary Outcomes

Description: 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

Measure: Type, incidence and severity of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)

Time: Day 1-90 days after injection

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

Measure: Chimeric Antigen Receptor T(CAR-T)Positive Cell Concentration

Time: Day 1-90 days after injection

Secondary Outcomes

Description: Recommended Phase 2 dose (RP2D)

Measure: Recommended phase 2 dose (RP2D) of this cell therapy

Time: Day 1-90 days after injection

Description: 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.

Measure: Overall response rate (ORR) after administration

Time: 2 years post infusion

Description: 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).

Measure: Duration of remission (DOR) after administration

Time: 2 years post infusion

Description: 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.

Measure: Progress Free Survival (PFS) after administration

Time: 2 years post infusion

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

Measure: Overall Survival (OS) after administration

Time: 2 years post infusion

Description: 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.

Measure: Time to Response (TTR) after administration

Time: 2 years post infusion

Description: 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.

Measure: Incidence of anti-LCAR-L10D antibody and positive sample titer

Time: Day 1-90 days after injection


HPO Nodes