SHANGHAI & PALO ALTO, Calif.—Cellular Biomedicine Group Inc., which focuses on developing treatments for degenerative and cancerous diseases, has released promising clinical data from its Chimeric Antigen Receptor (CAR-T) CD30-positive Hodgkin's lymphoma immuno-oncology clinical development program. Dr. William (Wei) Cao, CEO of Cellular Biomedicine Group, presented the data at the 10th Annual World Stem Cells & Regenerative Medicine Congress in London on May
This study was a Phase 1, open-label trial evaluating escalating dosee\s of autologous T cells transduced with a CD30-directed chimeric antigen receptor moiety for three to five days, consecutively. Using assigned protocol by Quantitative PCR, the participants' levels of CAR transgenes in peripheral blood and biopsied tumor tissues were measured periodically. The trials goals were to evaluate the safety, feasibility and efficacy of the treatment in patients with progressive relapsed/refractory Hodgkin's lymphoma following the administration of CD30-targeting CAR-T cells. Participants included male and female adults with heavy treatment histories—16 previous treatments, ranging from eight to 24—and/or multiple tumor lesions with no available curative treatment options and limited prognosis with existing therapies.
The participants for the study consisted of seven adult patients with relapsed/refractory Hodgkin's lymphoma. Two out of those seven patients achieved partial responses, with three out of the seven obtaining stable disease, for an overall disease control rate of 71.4 percent and an objective response rate of 28.6 percent. Only one patient experienced an adverse effect, which consisted of a five-day self-limiting arthralgias, myalgias and dual knee swelling two weeks after cell infusion.
"We are very encouraged by the efficacy and toxicity profile of our CAR-T CD30 technology, given that the cancer patients in the trials were diagnosed with Stage III and IV Hodgkin's lymphoma,” said Cao. “The patient selection criteria of our CAR-T studies are very stringent, as the participants enrolled are advanced, relapsed and refractory to other standard-of-care therapies. The results of this study has led us to move forward with this protocol into the treatment of relapsed/refractory CD30-positive lymphoma patients."
"We previously announced positive clinical data from our Phase 1 clinical trials for CD19 and CD20 constructs and expect to announce clinical data from our EGFR-HER1-positive advanced lung cancer trial in the third quarter of this year. We look forward to additional progress in advancing our Immuno-Oncology platform with further clinical developments of our CD19, CD20, CD30 and EGFR-HER1 constructs," he added.
As explained on Cellular Biomedicine Group's website, “CARs are proteins that allow the T cells to recognize a specific protein (antigen) on tumor cells. These engineered CAR T cells are then grown in the laboratory until they number in the billions. The expanded population of CAR T cells is then infused into the patient. After the infusion, if all goes as planned, the T cells multiply in the patient’s body and, with guidance from their engineered receptor, recognize and kill cancer cells that harbor the antigen on their surfaces. ”