Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

B-cell Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Antimetabolites

Mechlorethamine

Nitrogen Mustard Compounds

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Subjects will receive a conditioning lymphodepletion chemotherapy regimen of fludarabine and cyclophosphamide followed by infusion of CD22 CAR T cells on Day0.

Lymphodepletion:

* Fludarabine 25 mg/m2 per day IV for days 4, 3, -2
* Cyclophosphamide 900 mg/m2 per day IV on day -2

Autologous CD22 CAR T cells will be administered intravenously at Dose level 1 (1 x 10\^6 transduced T cells/kg (± 20%)).

Fludarabine is a purine antagonist antimetabolite

Cyclophosphamide is a nitrogen mustard derivative alkylating agent

Autologous T cells transduced with lentiviral vector (m971BBZ) Chimeric Antigen Receptor (CD22 CAR)

Autologous CD22 CAR T

Liora Schultz, MD

The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from pediatric and young adult subjects with relapsed/refractory B-cell malignancies (leukemia and lymphoma). Another purpose of this study is to test the safety and cancer killing ability of a cell therapy against a new cancer target (CD22).

PRIMARY OBJECTIVE:

* Determine the feasibility of manufacturing CD22 CAR T cells for administration to children and young adults with relapsed/refractory (R/R) CD22 expressing B-cell ALL or lymphoma using the Miltenyi CliniMACS Prodigy system.
* Determine the safety of an established dose of CD22-CAR T cells in children and young adults with R/R CD22 expressing B-cell malignancies.

SECONDARY OBJECTIVE:

- Assess the clinical activity of CD22-CAR T cells in children and young adults with R/R CD22 expressing B-cell malignancies, including overall survival (OS) and progression free survival (PFS).

CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies

Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies

The percentage of apheresis samples (fresh or frozen) that are successfully processed and expanded to manufacture CD22 CAR T cells that satisfy the target dose level and meet release specifications will be determined for each disease group (ALL or lymphoma).

Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD22 CAR T cells, as recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, at target dose of 1 x 10\^6 transduced T cells/kg (± 20%).

Clinical activity will be assessed by modified International Working Group response criteria for acute lymphoblastic leukemia (ALL). Results will be reported as best response (i.e. complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PR)) at Day 28 for adult subjects with ALL treated at the target dose.

Clinical activity will be assessed by Lugano response criteria for lymphoma. Results will be reported as best response (i.e. complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PR)) at Month 3 for adult lymphoma/DLBCL subjects treated at Maximum tolerated dose (MTD) /recommended phase 2 dose (RP2D).

Stanford University

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