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CAR T-cell Therapy

Dose Level 3 for Acute Lymphoblastic Leukemia

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

"This trial involves collecting T cells from participants' white blood cells through a procedure called leukapheresis. These T cells will be modified in a lab to create the CAR T-cell therapy that participants will

Who is the study for?

This trial is for people with a type of blood cancer called Acute Lymphoblastic Leukemia (ALL), specifically those who have seen their disease return. Participants must be eligible for leukapheresis, the procedure to collect white blood cells needed to create the therapy.Check my eligibility

What is being tested?

The study involves taking participants' T cells and modifying them in a lab to become 19-28z/IL-18 CAR T cells, which are designed to fight leukemia. The process from collection to receiving the modified cells as treatment takes about 2-4 weeks.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, and flu-like symptoms; complications from leukapheresis; or other issues specific to CAR T-cell therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Toxicity as determined by CTCAE, version 5.0

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Level 3Experimental Treatment1 Intervention

1x106 cells/kg with lymphodepleting chemotherapy (LDC)

Group II: Dose Level 2Experimental Treatment1 Intervention

0.5x106 cells/kg with lymphodepleting chemotherapy (LDC)

Group III: Dose Level 1Experimental Treatment1 Intervention

0.5x106 CAR-T cell/kg without lymphodepleting chemotherapy (LDC)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,880 Total Patients Enrolled

Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

14 Previous Clinical Trials

467 Total Patients Enrolled

Frequently Asked Questions

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

What is the current number of participants being enrolled in this research project?

"Affirmative. Data available on clinicaltrials.gov indicates that this investigation is presently seeking participants. The initial posting of this medical study was on February 23, 2024, and the most recent update occurred on February 29, 2024. In total, the trial aims to recruit 18 patients distributed among seven different sites."

Answered by AI

At how many distinct locations is this clinical trial currently being conducted?

"There are currently 7 active sites participating in this trial, including Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities) situated in Commack, Memorial Sloan Kettering Monmouth (Limited Protocol Activities) located in Middletown, and Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) found in Basking Ridge. Additionally, there are 4 more locations where the trial is being conducted."

Answered by AI

Are there any ongoing opportunities for patients to participate in this medical study?

"As documented on clinicaltrials.gov, this current trial is actively seeking eligible participants. The initial posting date was 23rd February 2024, with the most recent update performed on 29th February 2024."

Answered by AI

What are the potential risks associated with administering Dose Level 1 to individuals?

"Based on our assessment at Power, the safety rating for Dose Level 1 is a low score of 1. This corresponds to the early Phase 1 nature of the trial where there exists only limited evidence supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)

2024. "A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06287528.

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