A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies

Conditions

Patients with relapsed/refractory Lymphoma or ALL aged ≥ 3 years

Brief summary

The objective of this trial is to assess feasibility, safety and preliminary efficacy of ex vivo generated MB-CART2219.1 in patients with relapsed or refractory CD19 and/or CD22 positive B cell malignancies.

Detailed description

Disease Response (ORR, PR, CR) at 6 months, Dose/Response Relation, Progression free and overall survival, Non-Relapse Mortality, Progression-free survival on next line of treatment (PFS-2), Expansion of CAR+ T cells in the peripheral blood and if applicable bone marrow, CSF or other body fluids by flow cytometry, Evaluate the level of CD19/CD22-expressing malignant cells in tumor tissue, and if applicable peripheral blood and bone marrow, Evaluate the immunophenotype and/or expression profile of MB-CART2219.1 cells and endogenous immune and other hematopoietic cells in the peripheral blood, the bone marrow and/or tumor tissue., Evaluate levels of cytokines, chemokines, and soluble factors in the blood of subjects at baseline and after infusion of MB-CART2219.1 cells, Evaluate mechanisms of tumor sensitivity/resistance to MB-CART2219.1 cells, Evaluate the development of an anti-CAR cellular immune response after infusion of MB-CART2219.1 cells

Related papers

No related papers found yet.

Interventions

DRUGMB-CART2219.1

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The objective of this trial is to assess feasibility, safety and preliminary efficacy of ex vivo generated MB-CART2219.1 in patients with relapsed or refractory CD19 and/or CD22 positive B cell malignancies.	—

Secondary

Measure	Time frame
Disease Response (ORR, PR, CR) at 6 months, Dose/Response Relation, Progression free and overall survival, Non-Relapse Mortality, Progression-free survival on next line of treatment (PFS-2), Expansion of CAR+ T cells in the peripheral blood and if applicable bone marrow, CSF or other body fluids by flow cytometry, Evaluate the level of CD19/CD22-expressing malignant cells in tumor tissue, and if applicable peripheral blood and bone marrow, Evaluate the immunophenotype and/or expression profile of MB-CART2219.1 cells and endogenous immune and other hematopoietic cells in the peripheral blood, the bone marrow and/or tumor tissue., Evaluate levels of cytokines, chemokines, and soluble factors in the blood of subjects at baseline and after infusion of MB-CART2219.1 cells, Evaluate mechanisms of tumor sensitivity/resistance to MB-CART2219.1 cells, Evaluate the development of an anti-CAR cellular immune response after infusion of MB-CART2219.1 cells	—

Measure

Time frame

Disease Response (ORR, PR, CR) at 6 months, Dose/Response Relation, Progression free and overall survival, Non-Relapse Mortality, Progression-free survival on next line of treatment (PFS-2), Expansion of CAR+ T cells in the peripheral blood and if applicable bone marrow, CSF or other body fluids by flow cytometry, Evaluate the level of CD19/CD22-expressing malignant cells in tumor tissue, and if applicable peripheral blood and bone marrow, Evaluate the immunophenotype and/or expression profile of MB-CART2219.1 cells and endogenous immune and other hematopoietic cells in the peripheral blood, the bone marrow and/or tumor tissue., Evaluate levels of cytokines, chemokines, and soluble factors in the blood of subjects at baseline and after infusion of MB-CART2219.1 cells, Evaluate mechanisms of tumor sensitivity/resistance to MB-CART2219.1 cells, Evaluate the development of an anti-CAR cellular immune response after infusion of MB-CART2219.1 cells

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Countries

Germany

Outcome results

None listed