Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Autologous T cells transduced with a lentiviral vector to express anti-CD22 scFv TCRz:41BB

CART22-65s cells

Autologous T cells transduced with lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB

huCART19 Cells

Noelle Frey, MD

This is a single center, open-label, phase 1 study to determine the safety and feasibility of infusing CART22-65s with or without huCART19 after administration of lymphodepleting chemotherapy in adult patients with relapsed or refractory B-ALL.

CART22 Alone or in Combination With huCART19 for ALL

Phase 1 Study of Autologous Anti-CD22 Chimeric Antigen Receptor Redirected T Cells (CART22-65s) Alone and When Co-administered With Humanized Anti-CD19 Chimeric Antigen Receptor Redirected T Cells (huCART19) In Patients With Chemotherapy Resistant Or Refractory Acute Lymphoblastic Leukemia

Frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS).

Overall Complete Remission Rate (ORR) at Day 28 which includes CR and CR with incomplete blood count recovery (CRi).

overall response rate (CR/CRi by or at Month 6) and disease response status at Month 6

Engraftment and persistence in blood by qPCR (or flow cytometry)

Trafficking to target tissue (bone marrow) or other tissues (cerebral spinal fluid and other tissues if available) as determined by qPCR (or flow cytometry).

Measure levels of systemic soluble immune and inflammatory factors by Luminex-based analyses

Measure CD22, CD19 and B cell levels pre- and post-CAR T cell infusion by flow cytometry

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CART22 Alone or in Combination With huCART19 for ALL	NCT03620058	Chemotherapy Re... Refractory Acut...	CART22-65s cell... huCART19 Cells	18 Years -	University of Pennsylvania
CART22 Alone or in Combination With huCART19 for ALL	NCT03620058	Chemotherapy Re... Refractory Acut...	CART22-65s cell... huCART19 Cells	18 Years -	University of Pennsylvania
CART22 Alone or in Combination With huCART19 for ALL	NCT03620058	Chemotherapy Re... Refractory Acut...	CART22-65s cell... huCART19 Cells	18 Years -	University of Pennsylvania

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