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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 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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
585,426 Total Patients Enrolled
TakedaIndustry Sponsor
1,200 Previous Clinical Trials
4,178,116 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
~11 spots leftby Jul 2026