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

NCT06408194 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB-74214NCI-2024-04331
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia; Acute Lymphoblastic Leukemia

Keywords

KYMRIAH; CAR T; Tisagenlecleucel; Lymphodepletion

Outcome Measures

Primary Outcomes (2)

• The number of patients who experience dose limiting toxicities (Phase 1)

  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

  28 days after single infusion of CD22 CAR T cells

• The number of patients who successfully receive infusion of CD22CART (Phase 1b)

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

  within 42 days of infusion of tisagenlecleucel

Secondary Outcomes (2)

• Number of patients who have no evidence of leukemia

  28 days after single infusion of CD22 CAR T cells

• The number of patients who have B cell aplasia

  6 months following single infusion of CD22 CAR T cells and tisagenlecleucel

Study Arms (1)

Lymphodepletion

EXPERIMENTAL

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

Drug: CD22CART infusion; Drug: Tisagenlecleucel

Interventions

CD22CART infusion DRUG

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

Lymphodepletion

Tisagenlecleucel DRUG

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

Also known as: KYMRIAH

Lymphodepletion

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of histologically confirmed relapsed/refractory (R/R) B cell acute lymphoblastic leukemia (ALL)
• Must be eligible to receive commercial KYMRIAH® (tisagenlecleucel) according to FDA approved package insert (refractory disease or in second or later relapse)
• CD19 and CD22 expression must be demonstrated on malignant cells by immunohistochemistry or flow cytometry. CD19 and CD22 expression at any level of expression will be acceptable, as that is the standard for commercial KYMRIAH® (tisagenlecleucel) and the optimal level of CD22 expression is not well defined.
• Age: ≥ 1 year of age and ≤ 25 years and 364 days of age at time of enrollment.
• Performance Status: Participants \> 16 years of age: Karnofsky ≥ 50%; Participants ≤ 16 years of age: Lansky scale ≥ 50%.
• Normal Organ and Marrow Function
• Absolute Neutrophil Count (ANC) ≥ 750/uL\*
• Platelet count ≥ 50,000/uL\*
• Absolute Lymphocyte Count ALC \> 150/uL\*
• Adequate renal, hepatic, pulmonary and cardiac function defined as:
• Baseline oxygen saturation \> 92% on room air
• Creatinine within ULN for age or Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min
• Total bilirubin ≤ 1.5 mg/dl, except in Participants with Gilbert's syndrome. \[Elevations related to leukemia involvement of the liver will not disqualify a subject\]
• Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) ≤ 10 x ULN (except in Participants with liver involvement by leukemia)
• Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an Echocardiogram.

You may not qualify if:

• May not have Human Immunodeficiency Virus (HIV)/Hepatitis B (HBV) or Hepatitis C (HCV infection) or uncontrolled, symptomatic, intercurrent illness.
• May not have hyperleukocytosis (≥ 50,000 blasts/μL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.
• May not have severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study.
• May not have active CNS disorder, or history of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease with 12 months of enrollment.
• May not have primary immunodeficiency or history of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

tisagenlecleucel

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Michelle Fujimoto

CONTACT

(650) 736-0539; mfujimot@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 10, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)