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CAR T-cell Therapy

CD22-CAR T Cells for B-Cell Cancer

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

Females of childbearing potential must have a negative pregnancy test

Age must be greater than or equal to 1 year and ≤ 30 years at time of enrollment

Must not have

Ongoing infection with HIV or hepatitis B or hepatitis C virus

Hyperleukocytosis (≥ 50,000 blasts/μL) or rapidly progressive disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7-11 days after apheresis

Awards & highlights

No Placebo-Only Group

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.

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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an ongoing infection with HIV, hepatitis B, or hepatitis C.

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My white blood cell count is very high or my disease is getting worse quickly.

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I have an infection that isn't under control or needs IV drugs to manage.

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My leukemia has come back or didn't respond to treatment, and it's only in my testicles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-11 days after apheresis

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4