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Engineered T Cells for Blood Cancer (RESOLVE Trial)
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.
RESOLVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRESOLVE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RESOLVE Trial Design
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Who is running the clinical trial?
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- I do not have any infections that are not responding to treatment.I am between 6 months and 80 years old.I (or my guardian) can understand and agree to the study's terms.My T cell chimerism is over 94% after a recent stem cell transplant.My lymphocyte count is 600 or higher for a self-donated cell therapy.I have high-risk AML or MDS and had a stem cell transplant without my cancer returning.I haven't received T cell immunosuppressive drugs like ATG or Campath in the last 28 days.I have active lung, skin, or serous membrane conditions.I have GVHD over grade 2 for treatment options A and B, but no active GVHD for option C.I have had or will have a stem cell transplant from a donor.I am at high risk or have relapsed disease and may undergo a stem cell transplant.I have a specific type of blood cancer with active disease.My lymphoma is currently active.I have a history of cancer.I do not have any infections that are currently uncontrolled.I have severe graft-versus-host disease or related lung or skin conditions.I can do most activities but may need help.I have had a condition where my lymphocytes multiply unusually.I haven't had any cancer except for skin cancer in the last 5 years.
- Group 1: Tumor associated antigen lymphocytes (TAA-T)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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"
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