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CAR T-cell Therapy

CD22 CAR T-Cell Therapy for B-Cell Cancers

Phase 1

Waitlist Available

Led By Lori Muffly, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2; or Karnofsky ≥ 60%

Age greater than or equal to 18 years of age

Must not have

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

Presence of active fungal, bacterial, viral, or other infection requiring intravenous antimicrobials

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days after infusion of cd22 car t cells

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new immunotherapy treatment, using a patient's own immune cells, can be successful in treating adults with leukemia or lymphoma that has returned or does not respond to treatment.

Who is the study for?

Adults over 18 with certain B-cell blood cancers that have come back or didn't respond to treatment. They must be able to consent, not pregnant, willing to use birth control, and meet specific health criteria like a minimum number of white blood cells and proper organ function. Can't join if they're pregnant/breastfeeding, have other cancers within 3 years, severe infections needing IV drugs, significant heart issues in the past year or conditions affecting study participation.

What is being tested?

The trial is testing CD22-CAR T cells made from patients' own immune cells against relapsed/refractory B-cell malignancies. It includes pre-treatment with Fludarabine and Cyclophosphamide which are chemotherapy drugs used to prepare the body for CAR T cell therapy.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever and fatigue (cytokine release syndrome), neurological events like confusion or seizures (neurotoxicity), low blood cell counts leading to increased infection risk, bleeding or anemia, and potential damage to organs where cancerous cells may accumulate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but may not be able to do heavy physical work.

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I am 18 years old or older.

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My blood, kidney, liver, lung, and heart functions are normal.

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I have specific types of lymphoma and haven't had chemotherapy before it changed.

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My ALL hasn't responded to two treatments or has come back after a complete response.

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My cancer returned to the brain or spinal cord after it was previously gone.

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I have had a bone marrow or stem cell transplant.

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My condition is an aggressive type of B-cell Non-Hodgkin's Lymphoma.

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 am currently being treated with IV drugs for an infection.

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I have been cancer-free from another type of cancer for over 3 years.

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I am not pregnant or breastfeeding.

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My ALL has come back or didn't respond to treatment, and is only in my testicles.

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I have not needed strong medication for immune system issues in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days after infusion of cd22 car t cells

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days after infusion of cd22 car t cells

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days after infusion of cd22 car t cells for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

T-Lymphocyte

Rate of successful manufacture of CD22 CAR T cells

Safety evaluation of CD22-CAR T cells in subjects with ALL

Secondary study objectives

Clinical activity of CD22-CAR T cells in adults with relapsed/refractory CD22-expressing B-cell ALL at target dose

Clinical activity of CD22-CAR T cells in adults with relapsed/refractory aggressive B-cell NHL at MTD/RP2D

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 aggressive B-cell NHLExperimental Treatment3 Interventions

Relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Lymphodepletion prior to CD22 CAR T cell infusion (Day 0) will occur as follows: * Fludarabine 30 mg/m2 per day IV for days 5, 4, 3 * Cyclophosphamide 500 mg/m2 per day IV for days 5, 4, 3 Autologous CD22-CAR T cells will be administered in 3 escalating doses (Dose Level 1, 2, and 3) to determine MTD/RP2D. Dose1: 1 x 10\^6 cells/kg (± 20%) Dose2: 3 x 10\^6 cells/kg (± 20%) Dose3: 1 x 10\^7 cells/kg (± 20%)

Group II: R/R ALLExperimental Treatment3 Interventions

Relapsed/refractory ALL Lymphodepletion prior to CD22 CAR T cell infusion (Day 0) will occur as follows: * Fludarabine 30 mg/m2 per day IV for days 5, 4, 3 * Cyclophosphamide 500 mg/m2 per day IV for days 5, 4, 3 Autologous CD22 CAR T cells will be administered intravenously at Dose1: 3 x 10\^5cells/kg (± 20%) 10

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1830

Cyclophosphamide

2010

Completed Phase 4

~2310