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T Cell Therapy

T Cell Therapy for Leukemia

Phase 1 & 2

Waitlist Available

Research Sponsored by Everett Meyer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of active infection or viral hepatitis, HIV positive, Medical, physical, or psychological reason that would place the donor at increased risk for complications from growth factor or leukapheresis, Lactating female

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will study whether adding regulatory T cells to a T cell-depleted graft can reduce the incidence of acute graft vs. host disease while augmenting the graft vs. leukemia effect and improving immune reconstitution in patients with hematologic malignancies undergoing allogeneic myeloablative HCT.

Who is the study for?

This trial is for patients aged 13-75 with various blood cancers like acute leukemia, myelodysplastic syndromes, and non-Hodgkin's lymphoma. They must have a matched donor available for stem cell transplant, good organ function (heart, lungs, kidneys), and no active infections or HIV/hepatitis. Pregnant women and those who've had prior transplants or certain therapies are excluded.Check my eligibility

What is being tested?

The study tests whether infusing regulatory T cells along with conventional T cells into patients receiving a stem cell transplant from a donor can reduce complications such as graft vs host disease while improving the body's ability to fight cancer and recover its immune system.See study design

What are the potential side effects?

Potential side effects may include reactions related to the infusion of T cells, increased risk of infections due to immune system suppression by the treatment, and possible development of graft versus host disease where the donated cells attack the patient’s own tissues.

Eligibility Criteria

Inclusion Criteria

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

Select...

You have an active infection, viral hepatitis, or are HIV positive. You are not eligible if you have any medical or psychological conditions that may increase risks from the treatment. Additionally, if you are a lactating female, you cannot participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GvHD free Relapse free Survival (GRFS)

Secondary outcome measures

Concomitant Single-agent Immunosuppression

Dose-limiting toxicity (DLT)

Incidence and Severity of Chronic GvHD

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose escalationExperimental Treatment1 Intervention

For the Phase I arm of the study the addition of planned numbers and ratios of Treg compared to Tcon will occur at defined time points after hematopoietic cell infusion. Each cohort will have 3 patients per group. The initial doses and ratios utilized will be 1 x 10^6/kg of T reg cells to 3x10^6/kg of Tcon cells at a 1:3 ratio. In order to progress to the next dose level, there must be no evidence of grade 3 or 4 acute GVHD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Conventional T cells (Tcon) and Regulatory T cells (Treg)

2011

Completed Phase 2

~70

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,830 Previous Clinical Trials

47,302,686 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,690 Previous Clinical Trials

6,950,940 Total Patients Enrolled

Everett MeyerLead Sponsor

4 Previous Clinical Trials

79 Total Patients Enrolled

Media Library

Acute Leukemia Research Study Groups: Dose escalation

Frequently Asked Questions

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

Is the age limit for enrollment in this study above 25 years?

"This investigation is open to participants aged 13 and up, but below the age of 60."

Answered by AI

Are new participants currently being sought for this trial?

"Data on clinicaltrials.gov reveals that this medical research is not currently seeking participants, despite having been initially posted in December 2011 and most recently updated in May 2022. However, there are 3241 other trials actively recruiting presently."

Answered by AI

What are the requirements for participation in this research project?

"This medical trial is enrolling 68 patients aged 13 to 60 years, who have diffuse lymphoma. Participants must also fulfil the following conditions: Monosomal karyotype (-5, 5q-, -7, 7q-), Recipient Inclusion Criteria, translocation of chromosomes 11 and 23 (t[11; q23]), t(9;11), inv(3), t(3;3) t(6;9) t(9;22), Normal karyotype with fms-like tyrosine kinase 3 (FLT3)-internal tandem duplication mutation, Other high risk features as determined"

Answered by AI

Recent research and studies

JCI InsightJournal

Transplantation of Donor Grafts with Defined Ratio of Conventional and Regulatory T Cells in Hla-matched Recipients

Meyer, Everett H., Ginna Laport, Bryan J. Xie, Kate MacDonald, Kartoosh Heydari, Bita Sahaf, Sai-Wen Tang, et al.. 2019. “Transplantation of Donor Grafts with Defined Ratio of Conventional and Regulatory T Cells in Hla-matched Recipients”. JCI Insight. American Society for Clinical Investigation. doi:10.1172/jci.insight.127244.

clinicaltrials.govStudy

Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell

Everett Meyer 2011. "Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01660607.