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CAR T-cell Therapy

MultiTAA-Specific T Cells for Acute Lymphoblastic Leukemia (STELLA Trial)

Phase 1
Waitlist Available
Led By Bilal Omer, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimal residual disease (MRD) defined as detection in blood or marrow of leukemia-specific marker, leukemia-specific phenotype, or mixed donor chimerism
Available donor-derived multiTAA-specific T cell line
Must not have
Evidence of GVHD greater than Grade II
Severe intercurrent infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for leukemia that uses special blood cells to target proteins specific to the cancer.

Who is the study for?
This trial is for patients with Acute Lymphoblastic Leukemia (ALL) who have undergone a stem cell transplant but still face the risk of cancer returning or not responding to treatment. Eligible participants must have a life expectancy of at least 6 weeks, stable vital signs, and an available donor-derived T cell line. They should be treated within specific hospitals in Texas and agree to use effective birth control post-treatment.
What is being tested?
The study tests whether special blood cells called multiTAA-specific T cells can target and kill leukemia cells after being infused into patients post-stem cell transplant. These T cells are trained to recognize certain proteins found on most ALL cancer cells, aiming to find the highest safe dose for these patients.
What are the potential side effects?
Potential side effects aren't specified in this summary, but similar treatments often involve immune reactions, fatigue, fever, chills or risks associated with infusions such as infection at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tests show minimal signs of leukemia in my blood or bone marrow.
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I have access to a specific T cell line treatment.
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My cancer returned or remained after a transplant, confirmed by tests.
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I am scheduled for a stem cell transplant at CAGT.
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I will get my treatment at Texas Children's or Houston Methodist Hospital.
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I am able to live with some level of independence.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a complication from a transplant that is moderate to severe.
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I am currently suffering from a severe infection.
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I am currently on a high dose of corticosteroids.
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I had a stem cell transplant from a donor less than 30 days ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with dose-limiting toxicities (DLTs).
Secondary study objectives
Median number of T cells post-infusion.
Number of patients with a decrease in the marker of disease.

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment1 Intervention
Treatment with donor-derived multiTAA-specific T cells for relapsed/residual disease following HSCT for ALL.
Group II: Group AExperimental Treatment1 Intervention
Treatment with donor-derived multiTAA-specific T cells as adjuvant therapy following HSCT for ALL.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MultiTAA-specific T cells
2016
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,814 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
287 Previous Clinical Trials
81,740 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,122 Total Patients Enrolled
Bilal Omer, MDPrincipal InvestigatorBaylor College of Medicine
7 Previous Clinical Trials
279 Total Patients Enrolled

Media Library

MultiTAA-specific T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02475707 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Group A, Group B
Acute Lymphoblastic Leukemia Clinical Trial 2023: MultiTAA-specific T cells Highlights & Side Effects. Trial Name: NCT02475707 — Phase 1
MultiTAA-specific T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02475707 — Phase 1
~4 spots leftby Dec 2025
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