CURE's Clinical Trial Corner: June 2020

As the cancer treatment landscape continues to grow, patients and their caregivers should be aware of the various clinical trials currently being conducted — and ones they can possibly join.

CURE® has gathered a list of some of the most interesting trials happening across the cancer landscape that have just begun for patients with various types of cancer.

Leukemia and Lymphoma

Precision BioSciences has recently begun administering doses of PBCAR20A — an allogeneic chimeric antigen receptor (CAR) T-cell therapy candidate – to patients in a phase 1/2a clinical trial.

The therapy will be administered to two separate cohorts. The first cohort will include patients with relapsed/refractory non-Hodgkin lymphoma, and the second cohort will comprise patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or relapsed/refractory small lymphocytic lymphoma.

“This approach may allow us to address some patients who failed CD19 CAR T treatment and/or consider earlier line treatment to achieve meaningful clinical benefit in patients suffering with these diseases,” Dr. Chris Heery, chief medical officer of Precision BioSciences, said in a press release.

Pediatric Acute Lymphoblastic Leukemia or Acute Lymphoblastic Lymphoma

In collaboration with St. Jude’s Children’s Research Hospital and several other medical centers, the Children’s Hospital of Michigan has begun enrolling patients into the Total Therapy 17 trial to improve the cure rates and quality of life of children with acute lymphoblastic leukemia and acute lymphoblastic lymphoma.

The trial aims to treat 1,000 children across several medical centers within the United States and across the world.

“Genes can predispose children to cancer or regulate medication response. Every child who enrolls in Total 17 will undergo genomic testing of both normal tissue and leukemia cells to guide therapy,” Dr. Jeffrey Taub, division chief of oncology at Children’s Hospital of Michigan, said in a press release. “For the TOTAL17 protocol, patients can receive several days of treatment somewhere else and potentially come to Children’s Hospital of Michigan and switch to being treated on the TOTAL17 protocol.”

Advanced HPV-Associated Cancers

The first patient has been dosed in a phase 2 study evaluating the response rates of a novel triplet combination therapy in patients with HPV-associated cancers.

The goal is to enroll approximately 35 patients and treat them with PDS0101 (a therapy that combines a CAR T-cell therapy platform with targeted antigens) and Bintrafusp alfa (M7824) and NHS-IL12, two clinical development-stage immune-modulating agents.

Before the trial is scheduled to progress to full enrollment, investigators aim to evaluate safety and response to therapy in the first eight patients.

“We believe that PDS0101’s demonstrated preclinical efficacy when combined with these two immune-modulating agents, has the potential to significantly improve clinical outcomes for patients with advanced HPV-associated cancers,” Dr. Lauren Wood, chief medical officer of PDS Biotech, said in a press release.

Advanced Malignancies

The first patient has been dosed in a phase 1 clinical trial evaluating ALPN‑202, a first-in-class conditional CD28 co-stimulator and dual checkpoint inhibitor, in patients with advanced malignancies.

The trial, NEON-1, will include a dose escalation and expansion cohort of adult patients with advanced solid tumors or lymphoma refractory or resistant to standard therapy.

The aim of the study is to assess the complete and partial responses associated with the therapy, as well as the pharmacodynamics and pharmacokinetics of the therapy.