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CD22 CAR T Cells After Tisagenlecleucel for B-Cell Leukemia

This study is testing a new approach for children and young adults (ages 1 to 25) with B-cell acute lymphoblastic leukemia (ALL) that has come back or not responded to previous treatments. All participants will first receive a standard treatment called tisagenlecleucel (KYMRIAH®). Then, 28 to 42 days later, they will receive an infusion of CD22CART cells. The main goals are to find a safe dose of CD22CART and to see if it's possible to give this treatment after tisagenlecleucel. Researchers will also look at how well this combined treatment works and its effects on the body. This study aims to enroll 28 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is designed to first find a safe dose of CD22CART (Phase 1) and then to confirm the feasibility and safety of that dose (Phase 1b) in about 28 participants.
What's involved
You would first receive lymphodepletion, followed by an infusion of tisagenlecleucel. Then, 28 to 42 days later, you would receive an infusion of CD22CART.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure dose-limiting toxicities 28 days after the CD22 CAR T cell infusion and assess B cell aplasia at 6 months after the initial tisagenlecleucel infusion.

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NCT06408194

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

Recruiting
PHASE1Ages 1–25InterventionalTreatment
Stanford University
~28 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:CD22CART infusionTisagenlecleucel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of patients who experience dose limiting toxicities (Phase 1)
Measured over 28 days after single infusion of CD22 CAR T cells
+1 more outcome measured

Conditions

Leukemia
Acute Lymphoblastic Leukemia

Explore related trials

Acute Lymphoblastic LeukemiaCD19 GeneCD22 Gene

Where it's being run

1 sites across 1 states
California1

Who to contact

Michelle Fujimoto
[email protected]
(650) 736-0539
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is due to disease, based on the results of bone marrow studies. 7. Participants with Central Nervous System (CNS) involvement or a history of CNS involvement are eligible only in the absence of neurologic symptoms that may mask or interfere with neurological assessment of toxicity 8. Participants who have undergone autologous SCT with disease progression or relapse following SCT are eligible. Participants with history of allogeneic SCT must be at least 100 days from SCT, have no evidence of Graft versus Host Disease (GvHD), and no longer taking immunosuppressive agents for at least 30 days prior to enrollment. 9. Females of child bearing potential and males of child fathering potential must be willing to practice birth control during and for 4 months post chemotherapy or for as long as Chimeric Antigen Receptor (CAR) T cells are detectable in peripheral blood. 10. Females of child bearing potential must have negative pregnancy test. 11. Must meet wash out period since prior therapies according to commercial KYMRIAH® (tisagenlecleucel) SOPs. 12. Must have recovered from acute side effects from prior therapy to meet eligibility. 13. If had prior CAR therapy, will be eligible if at least 30 days has elapsed prior to apheresis. 14. Ability to give informed consent. All Participants ≥ 18 years of age must be able to give informed consent. For participants \<18 years old their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric participants will be included in age appropriate discussion and assent per institutional SOPs will be obtained for those \> 7 years of age, when appropriate. If a minor becomes of age during participation of this study, he/she will be asked to reconsent as an adult.
A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is felt by the investigator to be due to underlying disease.

What this trial measures

  • The number of patients who experience dose limiting toxicities (Phase 1)28 days after single infusion of CD22 CAR T cells

    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 (Phase 1b)within 42 days of infusion of tisagenlecleucel

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