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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
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

STELLA Trial 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.Check my eligibility
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.See study design
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.

STELLA Trial Eligibility Criteria

Inclusion Criteria

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

STELLA Trial 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

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

STELLA 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.

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,777 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
271 Previous Clinical Trials
80,355 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,000 Previous Clinical Trials
6,001,890 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

Frequently Asked Questions

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

Are recruitment efforts for this research initiative still open to the public?

"According to the website clinicaltrials.gov, this medical trial is not presently recruiting participants. Initially posted on February 1st 2016 and last updated September 21st 2022; though inactive it should be noted there are currently 486 other clinical trials open for enrollment at this time."

Answered by AI

Has the FDA sanctioned MultiTAA-specific T cells for therapeutic use?

"Currently, there is only limited evidence to support the safety and efficacy of MultiTAA-specific T cells. Therefore, our team at Power rates its safety as a 1 on a scale from 1 to 3."

Answered by AI
~4 spots leftby Apr 2025