← Back to Search

CAR T-cell Therapy

CAR T Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1

Recruiting

Led By Ibrahim Aldoss

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years

Awards & highlights

Study Summary

This trial tests a type of cancer treatment that changes a patient's immune cells in the lab to attack their cancer cells.

Who is the study for?

Adults aged 55 or older with B-cell acute lymphoblastic leukemia in first remission can join this trial. They must have a good performance status, proper liver and kidney function, and no severe infections like HIV or hepatitis. Women of childbearing age need a negative pregnancy test and agree to use birth control.Check my eligibility

What is being tested?

The trial is testing the safety and optimal dose of modified T cells (CD19-CAR T cells) that are designed to target leukemia cells in older adults. It involves taking the patient's own immune cells, modifying them in a lab, growing large numbers, and infusing them back into the patient.See study design

What are the potential side effects?

Potential side effects include reactions at infusion site, flu-like symptoms, fatigue, fever, headache, low blood pressure which could lead to dizziness or fainting; there may also be risk for more serious complications affecting different organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 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

Incidence of adverse events

Incidence of dose-limiting toxicity (DLT)

Secondary outcome measures

Event-free survival

Frailty phenotype score

Minimal residual disease (MRD) response rate

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CD19-CAR T cells)Experimental Treatment7 Interventions

Patients undergo T cell leukapheresis, receive fludarabine and cyclophosphamide IV, and then receive CD19-CAR T cell infusion IV on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Biospecimen Collection

2004

Completed Phase 2

~1700

Fludarabine

2012

Completed Phase 3

~1100

Leukapheresis

2016

Completed Phase 2

~690

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,639 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,420 Total Patients Enrolled

Ibrahim AldossPrincipal InvestigatorCity of Hope Medical Cancer Center

1 Previous Clinical Trials

71 Total Patients Enrolled

Media Library

Autologous Anti-CD19 CAR-expressing T Lymphocytes (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05707273 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: Treatment (CD19-CAR T cells)

Acute Lymphoblastic Leukemia Clinical Trial 2023: Autologous Anti-CD19 CAR-expressing T Lymphocytes Highlights & Side Effects. Trial Name: NCT05707273 — Phase 1

Autologous Anti-CD19 CAR-expressing T Lymphocytes (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05707273 — 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 CD19-CAR T cells therapy attained regulatory consent?

"Due to its Phase 1 status, which corresponds to limited evidence on safety and efficacy, Treatment (CD19-CAR T cells) was rated a score of 1 for overall security."

Answered by AI

Are there any opportunities to register as a participant in this experiment?

"Information found on clinicaltrials.gov affirms that this medical research is not currently seeking patients, although the trial was posted in April of 2023 and last updated a month later. However, there are 1482 other trials actively recruiting at present."

Answered by AI

What primary goals is the trial endeavoring to achieve?

"The primary efficacy measure of this clinical trial is the occurrence of adverse events within 28 days after CD19-chimeric antigen receptor (CAR) T cell infusion. Secondary outcomes examined include Minimal residual disease (MRD) response rate, Event-free survival and Overall survival rate, with assessments conducted using 95% Clopper Pearson binomial confidence intervals (CIs)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission

2023. "CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05707273.

All > All