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CAR T-cell Therapy

CAR T-Cell Therapy for B-Cell Lymphoma

Phase 1

Waitlist Available

Led By Jae Park, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry

Age ≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing the safety of 19(T2)28z1xx CAR T cells in people with relapsed/refractory B-cell cancers. The goal is to find the highest dose that causes few or mild side effects. Future trials will test if it is effective in treating relapsed/refractory B-cell cell cancers.

Who is the study for?

Adults with certain types of B-cell cancers that haven't responded to previous treatments, including specific lymphomas and leukemias. Participants must have measurable disease, adequate organ function, and agree to use effective contraception. Excluded are those with poor performance status, active CNS disease, recent heart issues or uncontrolled infections.Check my eligibility

What is being tested?

The trial is testing the safety of a new therapy called 19(T2)28z1xx CAR T cells for relapsed/refractory B-cell cancers. It aims to find the highest dose with minimal side effects and will also assess if this treatment effectively combats participants' cancer.See study design

What are the potential side effects?

While not detailed in the provided information, typical CAR T cell therapy side effects may include flu-like symptoms, fever, fatigue, difficulty breathing, rapid heartbeat and potential neurological events like confusion or seizures.

Eligibility Criteria

Inclusion Criteria

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

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My oxygen levels are 92% or higher on room air.

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I am 18 years old or older.

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My lymphoma has not responded well to previous treatments, including chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Recommended Phase II Dose (RP2D)

Secondary outcome measures

overall response rate (ORR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: 19(T2)28z1xx CAR T cellsExperimental Treatment1 Intervention

Cohorts of 3-6 patients will be infused with escalating doses of 19(T2)28z1XX CAR T cells to establish the RP2D. There are 4 planned flat-dose levels: 25x10^6, 50 x 10^6, 100 x 10^6 and 200 x 10^6 CAR T cells and one de-escalation dose: 12.5 x 10^6 CAR T cells. A standard 3+3 dose escalation design will be implemented starting from dose 1.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,780 Total Patients Enrolled

TakedaIndustry Sponsor

1,202 Previous Clinical Trials

4,178,232 Total Patients Enrolled

Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

14 Previous Clinical Trials

455 Total Patients Enrolled

Media Library

19(T2)28z1xx CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04464200 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: 19(T2)28z1xx CAR T cells

Non-Hodgkin's Lymphoma Clinical Trial 2023: 19(T2)28z1xx CAR T cells Highlights & Side Effects. Trial Name: NCT04464200 — Phase 1

19(T2)28z1xx CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04464200 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned 19(T2)28z1xx CAR T cells for therapeutic purposes?

"The relative safety of 19(T2)28z1xx CAR T cells was estimated to be a 1 due to the limited efficacy and safety data associated with Phase 1 trials."

Answered by AI

To what extent has enrollment grown in this clinical experiment?

"Affirmative, the clinical trial is still accepting applicants. According to information on clinicaltrials.gov, this study was initially posted on July 6th 2020 and has been up-to-date as of November 16th 2022. It seeks 30 participants from one medical facility."

Answered by AI

Are there any more slots open for enrollment in this research study?

"Indeed, the clinicaltrials.gov website demonstrates that this experiment is actively seeking volunteers. It was initially posted on July 6th 2020 and has since been updated on November 16th 2022. The research team needs to recruit 30 people from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers

2020. "19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04464200.

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