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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Incidence of dose-limiting toxicity (DLT)
Secondary study objectives
Event-free survival
Frailty phenotype score
Minimal residual disease (MRD) response rate
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Leukapheresis
2016
Completed Phase 2
~710

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,559 Total Patients Enrolled
89 Trials studying Leukemia
5,194 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,980 Total Patients Enrolled
1,534 Trials studying Leukemia
385,550 Patients Enrolled for Leukemia
Ibrahim AldossPrincipal InvestigatorCity of Hope Medical Cancer Center
2 Previous Clinical Trials
95 Total Patients Enrolled
2 Trials studying Leukemia
95 Patients Enrolled for Leukemia

Media Library

Autologous Anti-CD19 CAR-expressing T Lymphocytes (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05707273 — Phase 1
Leukemia Research Study Groups: Treatment (CD19-CAR T cells)
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
~11 spots leftby Jul 2026
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