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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

Timeline

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

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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.

STELLA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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.

0 / 6Eligibility criteria met

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

Recent research and studies

BloodJournal

Donor-derived Multiple Leukemia Antigen–specific T-cell Therapy to Prevent Relapse After Transplant in Patients with ALL

Naik, Swati, Spyridoula Vasileiou, Ifigeneia Tzannou, Manik Kuvalekar, Ayumi Watanabe, Catherine Robertson, Natalia Lapteva, et al.. 2022. “Donor-derived Multiple Leukemia Antigen–specific T-cell Therapy to Prevent Relapse After Transplant in Patients with ALL”. Blood. American Society of Hematology. doi:10.1182/blood.2021014648.

clinicaltrials.govStudy

Administration of Donor MultiTAA-Specific T Cells for ALL

Bilal Omer 2016. "Administration of Donor MultiTAA-Specific T Cells for ALL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02475707.