Engineered T Cells for Blood Cancer
(RESOLVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like PD-1 inhibitors or other T cell activating agents are excluded for some participants, and investigational therapies are not allowed within 28 days prior to the infusion.
Is engineered T cell therapy safe for humans?
Research shows that engineered T cells targeting tumor-associated antigens have been used safely in early clinical trials for various cancers, including solid tumors and blood cancers. These studies suggest that the treatment is generally safe, with efforts made to minimize potential side effects.12345
How is the treatment Tumor associated antigen lymphocytes (TAA-T) different from other treatments for blood cancer?
Tumor associated antigen lymphocytes (TAA-T) are unique because they are engineered T cells specifically designed to target multiple tumor-associated antigens (TAAs) found in blood cancers, allowing for a more precise attack on cancer cells. This approach differs from other treatments like chimeric antigen receptor (CAR) T cells, which typically target a single antigen, potentially making TAA-Ts more versatile and effective against a broader range of cancer cells.12367
What data supports the effectiveness of the treatment Tumor-associated antigen-specific T lymphocytes (TAA-T) for blood cancer?
Research shows that TAA-T cells have been used effectively in treating relapsed or refractory solid tumors and hematologic malignancies (blood cancers). These engineered T cells target specific proteins found in cancer cells, helping to kill them and potentially preventing relapse in conditions like acute myeloid leukemia.12358
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) with dose escalation to evaluate safety and efficacy
Follow-up
Participants are monitored for safety, including acute GVHD and other adverse events, and effectiveness after TAA-T infusion
Long-term follow-up
Event-free and overall survival are assessed, and incidence and severity of GVHD are monitored
What Are the Treatments Tested in This Trial?
Interventions
- Tumor associated antigen lymphocytes (TAA-T)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Catherine Bollard
Lead Sponsor
Children's National Research Institute
Collaborator
Johns Hopkins University
Collaborator