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CAR T-cell Therapy

Autologous CD22 CAR T for Lymphoma

Phase 1
Waitlist Available
Led By Liora Schultz, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with ALL must have evaluable or measurable disease.
Subjects with recurrence of isolated central nervous system CNS) relapse after achieving complete remission (CR).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-11 days after apheresis
Awards & highlights

Study Summary

This trial is testing a new cell therapy against a cancer target to see if it is safe and effective.

Who is the study for?
This trial is for children and young adults with certain types of B-cell cancers, like leukemia and lymphoma, that haven't responded to at least two previous treatments. They must have measurable signs of cancer despite treatment or a confirmed return of the disease after remission. Those with specific genetic changes in their leukemia are also eligible.Check my eligibility
What is being tested?
The study is testing a new cell therapy using CD22-CAR T cells made from the patient's own immune cells. It aims to see if these cells can be created successfully and whether they're safe and effective at targeting and killing cancer cells in patients with relapsed or resistant B-cell malignancies.See study design
What are the potential side effects?
Potential side effects may include reactions related to the infusion of CAR T-cells, such as fever, fatigue, headache, or more serious conditions like cytokine release syndrome (CRS), which causes flu-like symptoms but can be severe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ALL can be measured or seen through tests.
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My cancer returned in the brain or spinal cord after it was previously gone.
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My minimal residual disease has been confirmed twice, at least 2 weeks apart.
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My condition is lymphoma.
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I have Ph+ALL and my condition didn't improve after two treatments including TKIs.
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My lymphoma has not improved or has returned after treatment including specific drugs.
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I am of childbearing age and my pregnancy test is negative.
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I am between 1 and 30 years old.
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My ALL hasn't improved after 2 treatments or has come back after a complete response.
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My DLBCL has not improved after treatment with anthracycline and anti CD20.
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My lymphoma is an aggressive type of B cell NHL, confirmed by tests.
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My ALL can be measured or observed.
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I am mostly active and can care for myself.
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My condition worsened after a stem cell transplant.
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I have Ph+ALL and my condition didn't improve after two treatments, including TKIs.
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My cancer returned in the brain or spinal cord after it was gone.
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My leukemia or lymphoma cells test positive for CD22.
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My condition is Acute Lymphoblastic Leukemia (ALL).
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My cancer did not respond to two previous chemotherapy treatments.
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My lymphoma type is one of several specific types listed, including DLBCL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-11 days after apheresis
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-11 days after apheresis for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of successful manufacture of CD22 CAR T cells
Safe dose of CD22-CAR T cells in subjects with R/R B-cell malignancies
Secondary outcome measures
Clinical activity of CD22-CAR T cells in adults with R/R lymphoma
Clinical activity of CD22-CAR T cells in children and young adults with R/R CD22-expressing B-cell ALL and R/R lymphoma

Trial Design

2Treatment groups
Experimental Treatment
Group I: R/R B-ALLExperimental Treatment3 Interventions
Subjects will receive a conditioning lymphodepletion chemotherapy regimen of fludarabine and cyclophosphamide followed by infusion of CD22 CAR T cells on Day0. Lymphodepletion: Fludarabine 25 mg/m2 per day IV for days 4, 3, -2 Cyclophosphamide 900 mg/m2 per day IV on day -2 Autologous CD22 CAR T cells will be administered intravenously at Dose level 1 (1 x 10^6 transduced T cells/kg (± 20%)).
Group II: LymphomaExperimental Treatment3 Interventions
Subjects will receive a conditioning lymphodepletion chemotherapy regimen of fludarabine and cyclophosphamide followed by infusion of CD22 CAR T cells on Day0. Lymphodepletion: Fludarabine 25 mg/m2 per day IV for days 4, 3, -2 Cyclophosphamide 900 mg/m2 per day IV on day -2 Autologous CD22 CAR T cells will be administered intravenously at Dose level 1 (1 x 10^6 transduced T cells/kg (± 20%)).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,373 Previous Clinical Trials
17,327,952 Total Patients Enrolled
44 Trials studying Lymphoma
25,404 Patients Enrolled for Lymphoma
Liora Schultz, MDPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025