Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Recurrence

Lymphoma, Follicular

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Relapsed/refractory ALL

Lymphodepletion prior to CD22 CAR T cell infusion (Day 0) will occur as follows:

* Fludarabine 30 mg/m2 per day IV for days 5, 4, 3
* Cyclophosphamide 500 mg/m2 per day IV for days 5, 4, 3

Autologous CD22 CAR T cells will be administered intravenously at Dose1: 3 x 10\^5cells/kg (± 20%) 10

Relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.

Lymphodepletion prior to CD22 CAR T cell infusion (Day 0) will occur as follows:

* Fludarabine 30 mg/m2 per day IV for days 5, 4, 3
* Cyclophosphamide 500 mg/m2 per day IV for days 5, 4, 3

Autologous CD22-CAR T cells will be administered in 3 escalating doses (Dose Level 1, 2, and 3) to determine MTD/RP2D.

Dose1: 1 x 10\^6 cells/kg (± 20%) Dose2: 3 x 10\^6 cells/kg (± 20%) Dose3: 1 x 10\^7 cells/kg (± 20%)

Autologous T cells transduced with lentiviral vector (CD22.BB.Z) Chimeric Antigen Receptor (CD22 CAR). Autologous CD22 CAR T cells will be administered intravenously at Dose Level 1 in subjects with ALL. Autologous CD22-CAR T cells will be administered in 3 escalating doses (Dose Level 1, 2, and 3) in subjects with aggressive B-cell NHL to determine MTD/RP2D

CD22 CAR

Matthew Frank, MD, PhD

The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from adults with relapsed/refractory B-cell malignancies (leukemia and lymphoma).

Primary Objective:

* Determine the feasibility of manufacturing CD22 CAR T cells using the Miltenyi CliniMACS Prodigy® system for administration to adults with relapsed/refractory CD22 expressing B-cell ALL or relapsed/refractory aggressive B-cell non hodgkins lymphoma (NHL).
* Establish the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of CD22 CAR T cells in adults with relapsed/refractory aggressive B-cell NHL.
* Determine the safety of an established dose of CD22-CAR T cells in adults with relapsed/refractory CD22 expressing B-cell ALL and the safety of the MTD/RP2D of CD22-CAR T cells in adults with relapsed/refractory aggressive B-cell NHL.

Secondary Objective:

- Assess the clinical activity of CD22-CAR T cells in adults with R/R CD22 expressing B-cell ALL and R/R aggressive B-cell NHL, including overall survival (OS) and progressive free survival (PFS).

Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies

Phase I/Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in 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 will be determined for each dose cohort.

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 each dose level tested in subjects with aggressive B-cell NHL

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 each dose level tested in subjects with ALL

Clinical activity will be assessed by modified International Working Group response criteria for acute lymphoblastic leukemia. 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 (see Appendix 13.3.2). 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 aggressive B-cell NHL subjects treated at MTD/RP2D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies	NCT04088890	B-ALL B-cell Non Hodg... DLBCL Follicular Lymp...	Fludarabine Cyclophosphamid... CD22 CAR	18 Years -	Stanford University
Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies	NCT04088890	B-ALL B-cell Non Hodg... DLBCL Follicular Lymp...	Fludarabine Cyclophosphamid... CD22 CAR	18 Years -	Stanford University

Spots Global Cancer Trial Database for cd22 car

Every month we try and update this database with for cd22 car cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cd22 car

Every month we try and update this database with for cd22 car cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cd22 car cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.