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CAR T-cell Therapy

Human-Domain CAR T Therapy for Leukemia and Lymphoma

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

Male and female subjects age ≥ 1 and ≤ 30 years

No prior virotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 63 days

Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving genetically engineering a patient's own T cells to attack their tumor.

Who is the study for?

This trial is for young individuals (1-30 years old) with CD19+ leukemia or lymphoma that hasn't responded to other treatments. They must be able to undergo apheresis, have a life expectancy of at least 8 weeks, and use effective contraception. Those with severe infections, primary immunodeficiency, active malignancies besides the study's focus, symptomatic CNS issues uncontrolled by enrollment, or active GVHD are excluded.Check my eligibility

What is being tested?

The trial tests two versions of SCRI-huCAR19 CAR T cells designed to target CD19 on cancer cells. It aims to see if these genetically engineered T cells from patients can treat leukemia/lymphoma without being rejected by the body. The first phase checks safety; the second phase assesses effectiveness.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to cell infusion, symptoms related to organ inflammation caused by targeted cellular activity against cancerous cells expressing CD19 protein and general discomfort associated with cellular therapies.

Eligibility Criteria

Inclusion Criteria

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

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I am between 1 and 30 years old.

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I have never had treatment with viruses.

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I stopped taking corticosteroids more than a week ago.

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My leukemia or lymphoma has returned after CAR T cell treatment.

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My leukemia or lymphoma is not responding to treatment and tests positive for CD19.

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I can undergo apheresis or have enough T cells for treatment production.

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I can do most activities but need help with some.

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I am between 18 and 30 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 63 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~63 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 63 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 CAR T cell product infusions will be assessed

The leukemia response to SCRI-huCAR19 in subjects with relapsed or refractory CD19+ leukemia will be assessed

Trial Design

2Treatment groups

Experimental Treatment

Group I: SCRI-huCAR19v2Experimental Treatment1 Intervention

Patients will receive SCRI-huCAR19v2 in either Phase 1 or Phase II

Group II: SCRI-huCAR19v1 - [CLOSED]Experimental Treatment1 Intervention

Patients will receive SCRI-huCAR19v1 in either Phase 1 or Phase II. As of 02/13/2020 this study cohort is permanently closed.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

304 Previous Clinical Trials

5,217,284 Total Patients Enrolled

12 Trials studying Leukemia

1,236 Patients Enrolled for Leukemia

Colleen Annesley, MDStudy ChairSeattle Children's Hospital

3 Previous Clinical Trials

275 Total Patients Enrolled

3 Trials studying Leukemia

275 Patients Enrolled for Leukemia

Media Library

SCRI-huCAR19v1 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03684889 — Phase 1

Leukemia Research Study Groups: SCRI-huCAR19v1 - [CLOSED], SCRI-huCAR19v2

Leukemia Clinical Trial 2023: SCRI-huCAR19v1 Highlights & Side Effects. Trial Name: NCT03684889 — Phase 1

SCRI-huCAR19v1 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03684889 — Phase 1

Frequently Asked Questions

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

Does this medical trial include participants beyond the age of 20?

"For qualification, the minimum age requirement is 1 year and maximum is 30 years."

Answered by AI

Has the FDA sanctioned SCRI-huCAR19v2 for clinical utilization?

"Due to a lack of both safety and efficacy data, SCRI-huCAR19v2 has been assigned an initial risk rating of 1."

Answered by AI

Who is eligible to join this medical research?

"This trial is recruiting up to 16 participants with lymphoma and within the ages of 1 and 30 years old."

Answered by AI

Are there presently any openings for participation in this clinical experiment?

"The specified clinical trial is not presently enrolling patients, as per the information on clinicaltrials.gov; it was initially posted on November 28th 2018 and most recently updated on April 2nd 2022. However, there are a plethora of alternative trials currently looking for participants: in total, 2816 other trials are actively recruiting at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma

Colleen Annesley 2018. "CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03684889.

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