50 Participants Needed

Engineered T Cells for Blood Cancer

(RESOLVE Trial)

Recruiting at 2 trial locations
FH
Overseen ByFahmida Hoq, MBBS, MS
Age: Any Age
Sex: Any
Trial Phase: Phase 1
Sponsor: Catherine Bollard
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am between 6 months and 80 years old.
Agree to use contraceptive measures during study protocol participation
I (or my guardian) can understand and agree to the study's terms.
See 8 more

Exclusion Criteria

I do not have any infections that are not responding to treatment.
Pregnancy or lactating (female of childbearing potential)
No investigational therapies within 28 days prior to TAA-T infusion
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) with dose escalation to evaluate safety and efficacy

5 months
Multiple infusions based on dose level and response

Follow-up

Participants are monitored for safety, including acute GVHD and other adverse events, and effectiveness after TAA-T infusion

1 year

Long-term follow-up

Event-free and overall survival are assessed, and incidence and severity of GVHD are monitored

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Tumor associated antigen lymphocytes (TAA-T)
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Tumor associated antigen lymphocytes (TAA-T)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Catherine Bollard

Lead Sponsor

Trials
13
Recruited
290+

Children's National Research Institute

Collaborator

Trials
227
Recruited
258,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Published Research Related to This Trial

In a first-in-human trial involving 15 patients with relapsed or refractory solid tumors, tumor-associated antigen cytotoxic T cells (TAA-Ts) were administered safely without any dose-limiting toxicities, demonstrating a promising new therapeutic approach.
Of the evaluable patients, 73% showed stable disease or better at day 45 post-infusion, with 6 patients remaining progression-free for a median of 13.9 months, indicating that TAA-Ts can effectively stabilize disease and prolong time to progression.
Immunotherapy of Relapsed and Refractory Solid Tumors With Ex Vivo Expanded Multi-Tumor Associated Antigen Specific Cytotoxic T Lymphocytes: A Phase I Study.Hont, AB., Cruz, CR., Ulrey, R., et al.[2020]
Engineered T cells expressing T-cell receptors (TCRs) can specifically target tumor-associated antigens (TAAs), making them a promising approach in cancer treatment, particularly for hematologic malignancies.
Current early-phase clinical trials are testing TCR-T therapies targeting three different TAAs, while preclinical studies are exploring many more, indicating a broad potential for safe and effective cancer therapies.
T-Cell Receptor-Based Immunotherapy for Hematologic Malignancies.Biernacki, MA., Brault, M., Bleakley, M.[2023]
The study focuses on creating antigenic peptides from tumor-associated antigens (TAA) to develop effective cancer vaccines.
These antigenic peptides are designed to stimulate cytotoxic T lymphocytes (CTL), which are crucial for targeting and destroying cancer cells, and the effectiveness of this CTL induction is validated in the research.
Production of multiple CTL epitopes from multiple tumor-associated antigens.Morita, R., Hirohashi, Y., Nakatsugawa, M., et al.[2014]

Citations

Immunotherapy of Relapsed and Refractory Solid Tumors With Ex Vivo Expanded Multi-Tumor Associated Antigen Specific Cytotoxic T Lymphocytes: A Phase I Study. [2020]
T-Cell Receptor-Based Immunotherapy for Hematologic Malignancies. [2023]
Production of multiple CTL epitopes from multiple tumor-associated antigens. [2014]
[Clinical Research of Dendritic Cell-Mediated Tumor-Associated Antigen-Specific Cytotoxic T Lymphocytes in the Treatment of Multiple Myeloma and Non-Hodgkin Lymphoma]. [2020]
T cells targeting multiple tumor-associated antigens as a postremission treatment to prevent or delay relapse in acute myeloid leukemia. [2022]
Improving the efficacy and safety of engineered T cell therapy for cancer. [2020]
Trick to treat: tricking the thymus to treat cancer. [2021]
T-Cell Immunotherapies Targeting Histocompatibility and Tumor Antigens in Hematological Malignancies. [2021]
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