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CAR T-cell Therapy

Donor MultiTAA-specific T Cells for Leukemia & Preleukemia

Phase 1

Recruiting

Led By Premal Lulla, 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

Residual disease defined as PCR positivity, specific cytogenetic abnormalities, abnormal population on flow cytometry, or increased blasts on bone marrow biopsy, in peripheral blood or any other extramedullary sites

Minimal residual disease (MRD) defined as detection of leukemia-specific markers, expression of leukemia-associated antigens, leukemia-specific phenotype, or mixed donor chimerism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new experimental therapy using special blood cells to treat patients with leukemia or myelodysplastic syndrome that has come back or may come back after standard treatment.

Who is the study for?

This trial is for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who have had a stem cell transplant but still show signs of the disease. Participants need to have a compatible donor, stable vital signs, and agree to use effective birth control. They can't join if they've recently received certain immune therapies, are pregnant, have severe infections or GVHD above Grade II.Check my eligibility

What is being tested?

The study tests multiTAA-specific T cells from donors as an experimental therapy for AML/MDS after standard treatments fail. It aims to find the highest safe dose of these cells that can recognize and kill cancer cells expressing specific proteins.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, increased risk of infection due to immune system suppression, symptoms related to targeted organ damage by T cells recognizing TAAs on normal tissues, and possible development or worsening of graft-versus-host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tests show remaining cancer cells after treatment.

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My leukemia shows minimal signs but is still detectable.

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I can do most activities but may need help.

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I am eligible for a specific cell therapy after a stem cell transplant for my AML/MDS.

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I am scheduled for a stem cell transplant at CAGT.

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I have access to a specific T cell line treatment.

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.

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 AML or MDS

Group II: Group AExperimental Treatment1 Intervention

Treatment with donor-derived multiTAA-specific T cells as adjuvant therapy following HSCT for AML or MDS

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,331 Total Patients Enrolled

American Society for Blood and Marrow Transplantation (ASBMT)UNKNOWN

Cancer Prevention Research Institute of TexasOTHER

50 Previous Clinical Trials

98,394 Total Patients Enrolled

Media Library

MultiTAA-specific T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02494167 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Group B, Group A

Acute Myeloid Leukemia Clinical Trial 2023: MultiTAA-specific T cells Highlights & Side Effects. Trial Name: NCT02494167 — Phase 1

MultiTAA-specific T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02494167 — Phase 1

Frequently Asked Questions

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

Are MultiTAA-specific T cells likely to produce adverse effects in people?

"Taking into account the limited evidence of efficacy and safety, our experts assigned MultiTAA-specific T cells a score of 1 on the risk scale."

Answered by AI

How many participants can enroll in this research project?

"Affirmative. The web portal clinicaltrials.gov indicates that this research project, which was published on February 1st 2016, is currently recruiting participants. Approximately 44 patients have to be enrolled at 2 separate medical facilities."

Answered by AI

Is recruitment still open for this medical trial?

"Affirmative. According to clinicaltrials.gov, this research effort is still open for recruitment and was initially listed on February 1st 2016. It has since been updated on May 31st 2022 with the aim of enrolling 44 participants from 2 locations."

Answered by AI

Recent research and studies

BloodJournal

Clinical Effects of Administering Leukemia-specific Donor T Cells to Patients with AML/MDS After Allogeneic Transplant

Lulla, Premal D., Swati Naik, Spyridoula Vasileiou, Ifigeneia Tzannou, Ayumi Watanabe, Manik Kuvalekar, Suhasini Lulla, et al.. 2021. “Clinical Effects of Administering Leukemia-specific Donor T Cells to Patients with AML/MDS After Allogeneic Transplant”. Blood. American Society of Hematology. doi:10.1182/blood.2020009471.

BloodJournal

Clinical Effects of Administering Leukemia-specific Donor T Cells to Patients with AML/MDS After Allogeneic Transplant

clinicaltrials.govStudy

Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM)

Premal Lulla 2016. "Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02494167.