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CAR T-cell Therapy

Dual-Targeted CAR-T Therapy for Leukemia

Q: How many research sites have been established in the city for this experiment?

Presently, this trial is admitting patients at 5 centres. These cities are Indianapolis, Los Angeles and Seattle with two other locations nearby. To limit travel requirements for participants, it is encouraged to seek out the clinic closest to your residence.

Q: What are the potential risks of using CD19- and CD22 specific CAR for treatment?

Our team at Power assessed the safety of Patient-derived CD19- and CD22 specific CAR to be a 1, considering this is only Phase 1 trial with limited data supporting efficacy and safety.

Q: Are there any open enrollment slots available for this medical trial?

The clinical trial's record on clinicaltrials.gov reveals that recruitment is still ongoing; it was first made available to the public in November 2017 and its last update took place April 2022.

Q: What is the cap on patient participation in this research endeavor?

Affirmative. Per the information on clinicaltrials.gov, this medical experiment is actively recruiting participants – it was initially published on November 3rd 2017 and last updated on April 2nd 2022. 80 patients are required across 5 different locations to complete the trial's recruitment process.

Phase 1

Waitlist Available

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

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

Must have

First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects <31 years

Diagnosis of CD19+22+ leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial is testing a new way to treat leukemia by using genetically modified T-cells.

Who is the study for?

This trial is for patients under 31 years old with CD19+CD22+ leukemia that's resistant to standard treatments. They must have a life expectancy of at least 8 weeks, be free from severe infections or CNS dysfunction, not pregnant or breastfeeding, and able to tolerate cell collection procedures. Participants should also meet certain health and laboratory criteria.Check my eligibility

What is being tested?

The study tests a new therapy using the patient's own T-cells genetically modified to target two proteins on leukemia cells (CD19 and CD22). It aims to see if this dual-targeting approach is safe and feasible in producing enough modified T-cells for treatment.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to CAR-T cells targeting normal tissues expressing CD19/CD22, flu-like symptoms, fatigue, fever, difficulty breathing, changes in blood pressure or heart rate. The severity can vary among individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am under 31 years old.

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My leukemia tests positive for both CD19 and CD22.

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My leukemia has returned after a stem cell transplant and tests positive for CD19 and CD22.

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I haven't had active graft-versus-host disease and have been off related treatments for 4 weeks.

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I can do most activities but need help with some.

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It has been over a week since my last chemotherapy session.

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I have not had gene therapy or virus-based treatment that's still in my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The adverse events associated with one or multiple CAR T-cell product infusions will be assessed

The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patient-derived CD19- and CD22 specific CAR v2Experimental Treatment1 Intervention

Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt

Group II: Patient-derived CD19- and CD22 specific CAR v1Experimental Treatment1 Intervention

Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

301 Previous Clinical Trials

5,216,899 Total Patients Enrolled

12 Trials studying Leukemia

1,174 Patients Enrolled for Leukemia

Colleen Annesley, MDStudy ChairSeattle Children's Hospital

3 Previous Clinical Trials

213 Total Patients Enrolled

3 Trials studying Leukemia

213 Patients Enrolled for Leukemia

Rebecca Gardner, MDStudy Chair - Seattle Children's Hospital

Seattle Cancer Care Alliance, Seattle Children's Hospital

University Of Maryland School Of Medicine (Medical School)

University Of Wa School Of Medicine (Residency)

2 Previous Clinical Trials

173 Total Patients Enrolled

2 Trials studying Leukemia

173 Patients Enrolled for Leukemia

Media Library

Patient-derived CD19- and CD22-specific CAR-T Cell Immunotherapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03330691 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research sites have been established in the city for this experiment?

"Presently, this trial is admitting patients at 5 centres. These cities are Indianapolis, Los Angeles and Seattle with two other locations nearby. To limit travel requirements for participants, it is encouraged to seek out the clinic closest to your residence."

Answered by AI

What are the potential risks of using CD19- and CD22 specific CAR for treatment?

"Our team at Power assessed the safety of Patient-derived CD19- and CD22 specific CAR to be a 1, considering this is only Phase 1 trial with limited data supporting efficacy and safety."

Answered by AI

Are there any open enrollment slots available for this medical trial?

"The clinical trial's record on clinicaltrials.gov reveals that recruitment is still ongoing; it was first made available to the public in November 2017 and its last update took place April 2022."

Answered by AI

What is the cap on patient participation in this research endeavor?

"Affirmative. Per the information on clinicaltrials.gov, this medical experiment is actively recruiting participants – it was initially published on November 3rd 2017 and last updated on April 2nd 2022. 80 patients are required across 5 different locations to complete the trial's recruitment process."

Answered by AI

Recent research and studies

Cancer Immunology ResearchJournal

Rationally Designed Transgene-encoded Cell-surface Polypeptide Tag for Multiplexed Programming of CAR T-cell Synthetic Outputs

Johnson, Adam J., Jia Wei, James M. Rosser, Annette Künkele, Cindy A. Chang, Aquene N. Reid, and Michael C. Jensen. 2021. “Rationally Designed Transgene-encoded Cell-surface Polypeptide Tag for Multiplexed Programming of CAR T-cell Synthetic Outputs”. Cancer Immunology Research. American Association for Cancer Research (AACR). doi:10.1158/2326-6066.cir-20-0470.

Cancer Immunology ResearchJournal

Rationally Designed Transgene-encoded Cell-surface Polypeptide Tag for Multiplexed Programming of CAR T-cell Synthetic Outputs

HematologyJournal

Modified T Cells as Therapeutic Agents

Singh, Nathan. 2021. “Modified T Cells as Therapeutic Agents”. Hematology. American Society of Hematology. doi:10.1182/hematology.2021000262.

clinicaltrials.govStudy

A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia