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CAR T-cell Therapy

CAR T-Cell Therapy for Leukemia (PLAT-04 Trial)

Q: Am I eligible to join the research being conducted?

To qualify for enrolment in this clinical trial, candidates must have <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> and be aged between 1 Year and 26. As of now, 4 participants are being sought out to partake in the study.

Q: Are researchers still enrolling participants for this trial?

As confirmed on clinicaltrials.gov, this medical study has concluded its patient recruitment process and is no longer accepting participants - the trial was first posted in July 2017 and was last updated in February 2022. However, alternatively, there are currently 1411 other clinical trials that are actively recruiting patients for their research.

Q: How liable are Patient-derived CD22-specific CAR T-cells containing an EGFRt to cause harm?

Our team has allocated a safety rating of 1 to Patient-derived CD22-specific CAR T-cells which also express an EGFRt due to the limited research data available surrounding its efficacy and safety.

Q: Is the eligibility criteria for this research restricted to individuals under 25 years old?

Applicants eligible to join this research must be between 1 and 26 years old.

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

Subsequent subjects: 12 months of age and <27 years of age at the time of study enrollment

If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia recurrence, defined as ≥0.01% disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

PLAT-04 Trial Summary

This trial is testing a new way to treat leukemia by using the patient's own T-cells that have been genetically modified to target a different protein, CD22, that is found on the surface of the leukemia cells.

Who is the study for?

This trial is for children and young adults (12 months to <27 years old) with CD22+ leukemia or lymphoma that's come back or hasn't responded to treatment. They should have recovered from previous treatments, not be pregnant/breastfeeding, free of severe infections, other cancers, primary immunodeficiencies, and able to tolerate apheresis. Participants must agree to long-term follow-up and use effective contraception if applicable.Check my eligibility

What is being tested?

The study tests a new therapy using the patient's own T-cells genetically modified to target CD22 on leukemia/lymphoma cells. It aims to see if these CAR T-cells are safe and can be produced in sufficient amounts for treatment in those who've relapsed after standard therapies or have resistant disease.See study design

What are the potential side effects?

Potential side effects may include immune reactions where the body attacks its own cells (cytokine release syndrome), neurological events like confusion or seizures, allergic reactions during infusion, fatigue, fever, headache, low blood pressure, difficulty breathing.

PLAT-04 Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 12 months and 27 years old.

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

Select...

I need a stem cell transplant but can't have it, possibly due to remaining cancer cells.

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My lymphoma is CD22 positive and has not responded to treatment.

Select...

I have recovered from the side effects of my previous cancer treatments.

Select...

I have never had virotherapy.

Select...

My leukemia didn't respond well to at least 2 different treatments.

Select...

I can do most activities but need help with some.

Select...

My cancer has returned in the bone marrow more than once.

Select...

My condition has returned or didn't respond to treatment, and I haven't had a stem cell transplant from a donor.

PLAT-04 Trial 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

PLAT-04 Trial Design

1Treatment groups

Experimental Treatment

Group I: Autologous CD22-specific CAR T-cells expressing EGFRtExperimental Treatment1 Intervention

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

301 Previous Clinical Trials

5,216,973 Total Patients Enrolled

12 Trials studying Leukemia

1,248 Patients Enrolled for Leukemia

Corinne Summers, MDStudy ChairSeattle Children's Hospital

1 Previous Clinical Trials

42 Total Patients Enrolled

1 Trials studying Leukemia

42 Patients Enrolled for Leukemia

Media Library

Patient-derived CD22-specific CAR T-cells also expressing an EGFRt (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03244306 — Phase 1

Leukemia Research Study Groups: Autologous CD22-specific CAR T-cells expressing EGFRt

Leukemia Clinical Trial 2023: Patient-derived CD22-specific CAR T-cells also expressing an EGFRt Highlights & Side Effects. Trial Name: NCT03244306 — Phase 1

Patient-derived CD22-specific CAR T-cells also expressing an EGFRt (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03244306 — Phase 1

Frequently Asked Questions

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

Am I eligible to join the research being conducted?

"To qualify for enrolment in this clinical trial, candidates must have leukemia and be aged between 1 Year and 26. As of now, 4 participants are being sought out to partake in the study."

Answered by AI

Are researchers still enrolling participants for this trial?

"As confirmed on clinicaltrials.gov, this medical study has concluded its patient recruitment process and is no longer accepting participants - the trial was first posted in July 2017 and was last updated in February 2022. However, alternatively, there are currently 1411 other clinical trials that are actively recruiting patients for their research."

Answered by AI

How liable are Patient-derived CD22-specific CAR T-cells containing an EGFRt to cause harm?

"Our team has allocated a safety rating of 1 to Patient-derived CD22-specific CAR T-cells which also express an EGFRt due to the limited research data available surrounding its efficacy and safety."

Answered by AI