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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months following single infusion of cd22 car t cells and tisagenlecleucel

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.