Symptoms and General Pathology

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18-34 participants with FL will be administered the RP2D of CD22CART

12-32 participants with MCL will be administered the RP2D of CD22CART.

up to 30 participants with no more than 10 of any one type, including: Hairy cell leukemia, Lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia), Burkitt lymphoma, and Marginal zone lymphoma.

Dosing and Administration Participants will be hospitalized to receive treatment with CD22CART, if not previously hospitalized, and will remain hospitalized for approximately 5 to 7 (±2) days. Patients may be discharged once all AEs have resolved to Grade 1 or better, or at the discretion of the treating physician. Participants may be discharged with non critical and clinically stable or slowly improving toxicities (e.g., renal insufficiency, cytopenias) even if \> Grade 1, if deemed appropriate by the investigator.

CD22CART Infusion

Kelly Chyan

Kendall Levine

Matthew Frank, MD

Matthew Frank, MD, PhD

This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed / refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion.

AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas

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

Rate of successful manufacture of CD22CART cells at the target dose level that meet required release specifications in Cohort 1, Cohort 2, and Cohort 3.

Establish the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of CD22CART cells in 3 cohorts of adults with relapsed/refractory B Cell lymphoma.

Assess the ORR at 3 months post CD22 CART infusion as defined by the disease specific response criteria for Cohort 1 (FL) and Cohort 2 (MCL)

Evaluate Progression Free Survival (PFS) in adults with relapsed/refractory B cell lymphoma after receiving CD22CART. PFS defined as the interval from CD22CART infusion to time of disease progression or death from any cause

Evaluate Overall Survival (OS) in adults with relapsed/refractory B cell lymphoma after receiving CD22CART. OS defined as the interval from CD22CART infusion to the time of death from any cause.

Evaluate Duration of Response (DOR) in adults with relapsed/refractory B cell lymphoma after receiving CD22CART. DOR defined as the interval from achieving an objective response to the time of disease progression.

Describe the response rates assessed at 3 months post CD22 CART infusion for Cohort 3 (HCL, WM, BL, and MZL).

The Leukemia and Lymphoma Society

Stanford University

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Tisagenlecleucel

Antineoplastic Agents, Immunological

All enrolled participants will receive lymphodepletion followed by standard of care tisagenlecleucel infusion.

CD22CART will be administered after Standard of Care (SOC) administration of tisagenlecleucel.

CD22CART infusion

Michelle Fujimoto

Kara L Davis, DO

The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.

Primary Objectives:

Phase 1 portion (Safety lead-in):

Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) dose of CD22CART in children and young adults with R/R CD19 and CD22 expressing B-cell malignancies administered after infusion of tisagenlecleucel according to FDA approved dose range.

Phase 1b portion (Expansion cohort) Establish the feasibility of delivering CD22CART following infusion of commercial tisagenlecleucel, administered per FDA approved Package Insert, in children and young adults with B cell malignancies.

Determine the safety of administering the RP2D of CD22CART 28 to 42 days after infusion of FDA approved commercial tisagenlecleucel in children and young adults with B cell malignancies.

Secondary Objectives:

1. Describe the clinical activity of serial infusion of tisagenlecleucel followed by CD22CART in children and young adults with R/R B-cell malignancies.
2. Assess the rate of ongoing B cell aplasia at 6 months after initial tisagenlecleucel infusion, when tisagenlecleucel is followed by serial CD22CART infusion within 42 days.

Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies

Phase I/Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells Following Commercial CD19 CAR T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies

The number of patients who experience dose limiting toxicities within 28 days of administration of CD22 CART when given within 28-42 days of infusion of tisagenlecleucel

The number of patients who successfully receive infusion of CD22CART within 42 days of infusion of tisagenlecleucel

Number of patients who have no evidence of leukemia (complete response or complete response with incomplete count recovery) at Day 28 following CD22 CART infusion.

The number of patients who have B cell aplasia 6 months following tisagenlecleucel and CD22 CART infusion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas	NCT06340737	Follicular Lymp... Mantle Cell Lym... Hairy Cell Leuk... Lymphoplasmacyt... Burkitt Lymphom... Marginal Zone L... Waldenstrom Mac...	CD22CART Infusi...	18 Years -	Stanford University
Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies	NCT06408194	Leukemia Acute Lymphobla...	CD22CART infusi... Tisagenlecleuce...	1 Year - 25 Years	Stanford University

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