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CAR T-cell Therapy

CD22 CAR T Cells for Leukemia

Phase 1
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of histologically confirmed relapsed/refractory (R/R) B cell acute lymphoblastic leukemia (ALL)
Participants who have undergone autologous SCT with disease progression or relapse following SCT are eligible
Must not have
Hyperleukocytosis (≥ 50,000 blasts/μL) or rapidly progressive disease
HIV/HBV or HCV infection or uncontrolled, symptomatic, intercurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following single infusion of cd22 car t cells and tisagenlecleucel
Awards & highlights

Summary

"This trial aims to test the safety and effectiveness of CD22 CART cells in children and young adults with relapsed or refractory B-cell leukemia after they have received tisagenlecleucel treatment

Who is the study for?
This trial is for children and young adults with B-cell leukemia that has come back or hasn't responded to treatment. They must have already received a commercial CAR T cell therapy called tisagenlecleucel.
What is being tested?
The study tests the safety and optimal dosing of CD22 CART cells given 28 to 42 days after tisagenlecleucel in patients with relapsed or refractory B-cell leukemia.
What are the potential side effects?
Potential side effects may include immune system reactions, fever, fatigue, headache, low blood pressure, difficulty breathing, and risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia has returned or didn't respond to treatment.
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My condition worsened after a stem cell transplant.
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My condition qualifies me for KYMRIAH® treatment as per FDA guidelines.
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My cancer cells test positive for CD19 and CD22.
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I am between 1 and 25 years old.
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I am over 16 and can do most activities, or I am 16 or under and can be active more than half the time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My white blood cell count is very high or my disease is getting worse quickly.
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I do not have HIV, HBV, HCV, or any uncontrolled illness.
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I haven't had a heart attack, heart surgery, or unstable heart conditions in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following single infusion of cd22 car t cells and tisagenlecleucel
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following single infusion of cd22 car t cells and tisagenlecleucel for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The number of patients who experience dose limiting toxicities (Phase 1)
The number of patients who successfully receive infusion of CD22CART (Phase 1b)
Secondary study objectives
Number of patients who have no evidence of leukemia
The number of patients who have B cell aplasia

Trial Design

1Treatment groups
Experimental Treatment
Group I: LymphodepletionExperimental Treatment2 Interventions
All enrolled participants will receive lymphodepletion followed by standard of care tisagenlecleucel infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tisagenlecleucel
2019
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,374 Total Patients Enrolled
42 Trials studying Leukemia
11,871 Patients Enrolled for Leukemia
~13 spots leftby Jun 2025
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