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CAR T-cell Therapy

Engineered T Cells for Blood Cancer (RESOLVE Trial)

Phase 1
Recruiting
Research Sponsored by Catherine Bollard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 6 months to 80 years
T cell chimerism > 94% if collected from recipient of allo-HSCT within the last 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

RESOLVE Trial Summary

This trial will test if it is safe to give HSCT recipients T cells that have been engineered to kill tumor cells. It will also test if this treatment improves the six-month event-free survival rate for patients with high-risk AML or MDS.

Who is the study for?
This trial is for people aged 6 months to 80 years with certain high-risk blood cancers or tumors who have had, or will have, a stem cell transplant. They must be in relatively good health otherwise and agree to use contraception if applicable. Pregnant women, those with severe graft-versus-host disease (GVHD), uncontrolled infections, or recent treatment with certain immune therapies are excluded.Check my eligibility
What is being tested?
The study tests TAA-T cells in patients receiving stem cell transplants for aggressive blood cancers. It's divided into three arms: A) post-transplant patients; B) pre-transplant patients; C) post-transplant without relapse. The goal is to see if these cells improve survival without the cancer returning after six months.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as GVHD where the donor cells attack the patient’s body, infection risks due to weakened immunity from treatments, and typical infusion-related symptoms like fever or chills.

RESOLVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 months and 80 years old.
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My T cell chimerism is over 94% after a recent stem cell transplant.
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My lymphocyte count is 600 or higher for a self-donated cell therapy.
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I have high-risk AML or MDS and had a stem cell transplant without my cancer returning.
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I have had or will have a stem cell transplant from a donor.
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I have a specific type of blood cancer with active disease.
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My lymphoma is currently active.
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I can do most activities but may need help.

RESOLVE Trial Timeline

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
Safety of investigational product (TAA-T)
Secondary outcome measures
Tumor associated antigen lymphocytes (TAA-T) responses
Other outcome measures
Event free and overall survival
The incidence and severity of acute and/or chronic GVHD

RESOLVE Trial Design

1Treatment groups
Experimental Treatment
Group I: Tumor associated antigen lymphocytes (TAA-T)Experimental Treatment1 Intervention
For Arm A Patients (post-HSCT): TAA-T will be infused any time after neutrophil engraftment post-HSCT or day 30, whichever comes first. For Arm B Patients (pre-HSCT): TAA-T will be infused any time > 7 days after previous therapy for relapsed disease. For Arm C Patients (post-HSCT): TAA-T will be infused any time after neutrophil engraftment post-HSCT or day 30, whichever comes first. All infusions will be within 5 months post-HSCT. Five different dosing levels will be evaluated. Two to four patients will be evaluated on each dosing schedule (see below). This protocol is designed as a phase I dose-escalation study. Dose Level One: 5 x 106 cells/m2 Dose Level Two: 1 x 107 cells/m2 Dose Level Three: 2 x 107 cells/m2 Dose Level Four: 4 x 107 cells/m2 Dose Level Five: 1 x 108 cells/m2 (ONLY applicable to Arm A patients) Arm C patients will ONLY be enrolled at: Dose Level Four (4 x 107 cells/m2)

Find a Location

Who is running the clinical trial?

Catherine BollardLead Sponsor
13 Previous Clinical Trials
241 Total Patients Enrolled
Children's National Research InstituteOTHER
209 Previous Clinical Trials
207,655 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,246 Previous Clinical Trials
14,816,680 Total Patients Enrolled

Media Library

Tumor associated antigen lymphocytes (TAA-T) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02203903 — Phase 1
Hematopoietic Malignancies Research Study Groups: Tumor associated antigen lymphocytes (TAA-T)
Hematopoietic Malignancies Clinical Trial 2023: Tumor associated antigen lymphocytes (TAA-T) Highlights & Side Effects. Trial Name: NCT02203903 — Phase 1
Tumor associated antigen lymphocytes (TAA-T) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02203903 — Phase 1

Frequently Asked Questions

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

Is the age range for this trial greater than forty-five?

"The qualifications for this medical experiment necessitate enrollees to be between 6 months and 80 years old. Research studies conducted with younger patients (under 18) numbered 336, while those involving seniors (65+) totaled 2326."

Answered by AI

What is the patient cohort for this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this research study has been active since January 1st 2015 and is currently seeking 90 participants from two distinct sites."

Answered by AI

Is enrollment currently available for this clinical trial?

"According to the information hosted on clinicaltrials.gov, this experiment is in the process of enrolling participants. It was initially listed online on January 1st 2015 and had its most recent update on August 30th 2022."

Answered by AI

Has the FDA given approval for Tumor associated antigen lymphocytes (TAA-T) to be used in practice?

"There is limited clinical data to support the safety and efficacy of Tumor associated antigen lymphocytes (TAA-T), thus we have rated it a 1 on our scale."

Answered by AI

Do I qualify to engage in this trial?

"This clinical trial necessitates 90 participants aged 6 months to 80 years with a Karnofsky/Lansky score of 50 or higher who are diagnosed with cancer. Patients must also comply with the following conditions: display active malignancy as confirmed by flow cytometry, morphology, PET/CT scans; have accepted an allogenic hematopoietic stem cell transplantation in the past (or be expecting one); use contraception when applicable; and provide informed consent if they are above age 18 or have parental approval. Furthermore, T-cell chimerism should exceed 94% for those under Arm C and absolute lymphocyte count has to"

Answered by AI
~20 spots leftby Nov 2026