multiTAA Specific T Cells for Pancreatic Cancer
(TACTOPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explored a new treatment for pancreatic cancer using special immune cells called TAA-specific cytotoxic T lymphocytes (multiTAA specific T cells). These cells target proteins (TAAs) mostly found on cancer cells, not normal ones. The study involved patients whose cancer returned, didn’t respond to standard treatments, or those planning surgery after treatment. It specifically targeted individuals with pancreatic cancer fitting these scenarios. However, the trial is currently closed to new patient enrollment. As a Phase 1 trial, the research focused on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you need to be off other investigational therapies for one month and conventional therapies for at least one week before starting the study treatment. If you are on systemic corticosteroids, you must stop them at least 48 hours before participating.
Is there any evidence suggesting that this trial's treatment is likely to be safe?
Research has shown that multiTAA specific T cells have been tested in patients with pancreatic cancer. In one study, 13 patients received this treatment, and the results indicated it was generally safe. Most patients tolerated the treatment well, with no serious side effects directly linked to it.
These T cells represent a type of immune therapy. They target specific proteins found on cancer cells, which are uncommon on normal cells. This targeting reduces the likelihood of harming healthy cells. Current evidence suggests that multiTAA T cell therapy could be safe for humans, but further studies are needed to confirm this.12345Why are researchers excited about this trial's treatment?
Unlike the standard treatments for pancreatic cancer, which typically involve chemotherapy and radiation, multiTAA specific T cells use a different approach by harnessing the body's own immune system. These T cells are engineered to specifically target and attack cancer cells, potentially offering a more precise and personalized treatment option. Researchers are excited because this immunotherapy could enhance the body's natural defenses against cancer without the broad side effects often associated with traditional chemotherapy. By focusing on the immune system, there is hope for improved outcomes and possibly fewer side effects, making this a promising avenue for patients who have limited options.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
Research shows that a new treatment using multiTAA specific T cells may help treat pancreatic cancer. In this trial, participants will receive multiTAA specific T cells in different contexts. One group of patients with resectable pancreatic adenocarcinoma will receive these T cells following neoadjuvant chemotherapy and surgery. Another group with locally advanced or metastatic pancreatic adenocarcinoma will receive the T cells after responding to first-line chemotherapy. A third group, also with advanced pancreatic cancer, will receive the T cells if they have failed or are intolerant to standard chemotherapy. A study found that this treatment is safe for patients with advanced pancreatic cancer, even when used with chemotherapy. The results also suggest it could be effective as a first treatment option when combined with chemotherapy. Early findings indicate that these T cells can recognize and attack proteins found mostly on cancer cells, which may help the immune system fight the cancer. This treatment specifically targets proteins called tumor-associated antigens (TAAs), which are mostly found on cancer cells and not on normal cells.24678
Who Is on the Research Team?
Benjamin Musher
Principal Investigator
Baylor College of Medicine
Anne Leen, PhD
Principal Investigator
Baylor College of Medicine
Are You a Good Fit for This Trial?
This trial is for adults over 18 with pancreatic cancer that's persistent after treatment, or those who've chosen not to undergo standard chemotherapy. Candidates must have a life expectancy of at least 6 months, be off other investigational therapies for a month, and not be pregnant. Men must use condoms; women should use effective birth control if they can bear children.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
T Cell Manufacturing
Blood is collected from patients to manufacture TAA-specific cytotoxic T cells in the lab, which takes about 1 to 2 months.
Treatment
Patients receive up to six doses of TAA-CTLs at monthly intervals, with pre-treatment using acetaminophen and diphenhydramine to prevent allergic reactions.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with blood tests and imaging studies to evaluate tumor response.
Long-term Follow-up
Investigators contact patients once a year for up to 4 additional years to evaluate disease response long-term.
What Are the Treatments Tested in This Trial?
Interventions
- multiTAA specific T cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborator
The Methodist Hospital Research Institute
Collaborator
Pancreatic Cancer Action Network
Collaborator
The V Foundation for Cancer Research
Collaborator
Harris County Hospital District
Collaborator