Levine Cancer Institute Enrolls World's First Patient in Specialized Lymphoma Clinical Trial

We are pleased to announce that Levine Cancer Institute (LCI) enrolled the first patient in the world in an innovative phase I clinical trial for patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma. Since LCI has a substantial number of patients who are included in this population, the overarching goal in launching the trial is to develop an additional opportunity for patients needing clinical care when previous therapies are no longer effective.

Ryan Jacobs, MD, is the principal investigator of this study. As an expert in lymphoma, Dr. Jacobs was excited when presented with the opportunity to enroll a patient in this new trial.

“This study caught my interest because of the previous effectiveness that we have seen with therapies that go after this specific target,” said Dr. Jacobs. “We are always thinking about our patients who have tried multiple options and need additional care. We felt strongly that this could be a good opportunity for them.”

LCI gets many invitations to participate in clinical trials and each potential option is vetted carefully and thoroughly by a robust team of interdisciplinary experts. “We evaluate each option by asking several questions, such as: ‘what is best for our patients, can we get the trial open in time to participate in a meaningful way, can we contribute substantially to the research, and is this an unmet need for our patients?” said Dr. Jacobs.

When reviewing the opportunity to participate in the TeneoTwo TNB-486.001: A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-486, a Bispecific Antibody, in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, the team at LCI determined that yes, this would be a meaningful clinical trial to enroll a patient in.

In record time, LCI’s clinical trials office opened the trial and Nilanjan Ghosh, MD PhD, chief, lymphoma division at Levine Cancer Institute, had a patient who was an ideal candidate for this therapy and readily accepted the opportunity to be the first patient in the world enrolled in the trial.

“This is a great accomplishment that was achieved through the hard work and collaboration of many intra-disciplinary teams across LCI. It is also another example of the positive impact that our work has serving our community,” said Tatiana Khorokhorina, RN, BSN, MBA, associate director, Phase I Clinical Trials at Levine Cancer Institute.

The treatment the patient received on the trial is in the class of immune therapy, a type of therapy that engages the immune system to attack the cancer. After receiving the therapy, the patient was closely monitored by the clinical team at Atrium Health Carolinas Medical Center for 24 hours and there were no serious side effects. In early March 2021, the patient went home with no concerns. Despite the nervous tension that would typically go into enrolling the first patient in the world in a trial, Dr. Jacobs and the team remained positive throughout the process and believed it was a meaningful option.

“I was confident with this drug and had seen that there could be a significant clinical benefit to a patient when using a treatment like this. The research and data were strong, and the expectation is that this drug would be well tolerated by a patient,” said Dr. Jacobs. “That being said, I did feel best when I saw how well everything went in reality!”

Since this treatment was considered experimental, it came at no cost to the patient and as a bonus, they received the personalized support of a research nurse to serve as their navigator and advocate throughout the process.

The patient will continue to receive treatment once every two weeks, and eventually receive an evaluation in a couple of months to determine how effective the treatment was on eradicating their cancer. Going forward, treatment will be able to be transitioned to the outpatient setting given the good initial tolerance.

Please join us in congratulating Dr. Jacobs, Dr. Ghosh, Tatiana Khorokhorina, Phil Butera, and everyone else who made this incredible achievement feasible. Most importantly, we want to give a special thank you to all our patients who are part of clinical trials. Trials are the key to advancing effective and safe treatment options for patients.