Around the Helix: Cell and Gene Therapy Company Updates – December 10, 2025

The cell and gene therapy sectors are growing exponentially, with new players emerging daily and much progress being made both in and out of the lab. CGTLive®’s Around the Helix is your chance to catch up with the latest news in cell and gene therapies, including partnerships, pipeline updates, and more.

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1. FDA Approves BMS’s Liso-Cel for R/R Marginal Zone Lymphoma

The FDA approved Bristol Myers Squibb’s autologous CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy lisocabtagene maraleucel (liso-cel, marketed as Breyanzi) for the treatment of relapsed/refractory (r/r) marginal zone lymphoma in adults who have previously been treated with at least 2 lines of systemic therapy.

2. Autologous Stem Cell Therapy for Alzheimer Disease Advances to Phase 2 After Positive Early Findings

At the 18th Clinical Trials on Alzheimer’s Disease (CTAD) conference, held December 1-4, 2025, in San Diego, California, investigators shared promising phase 1 data supporting the safety and feasibility of RB-ADSC, an autologous Wnt-enriched stem cell therapy delivered directly to the brain for patients with Alzheimer disease.

3. FasTCAR Manufactured BCMAxCD19 CAR T-cell Therapy Shows Promise for Multiple Myeloma

The next-generation dual BCMA and CD19-targeted CAR T-cell therapy AZD0120 that was manufactured rapidly using the FasTCAR technology elicited an objective response in nearly all patients with relapsed/refractory multiple myeloma, according to preliminary findings from the phase 1b/2 DURGA-1 study (NCT05850234) presented at the 67th ASH Annual Meeting and Exposition, held December 6 to 9, 2025, in Orlando, Florida.

4. The Use of Artificial Intelligence in Genetic Counseling

At the 44th National Society of Genetic Counselors (NSGC) Annual Conference, held November 6 to 10 in Seattle, Washington, CGTLive® interviewed Colleen Caleshu, MS, CGC, the senior director of research and real world data at Genome Medical, who chaired a session on the use of AI by genetic counselors, to get her insight on the key takeaways that were discussed by the session's speakers.

5. Senti Bio's SENTI-202 Snags RMAT Designation

Senti Bio has received a regenerative medicine advanced therapy (RMAT) designation from the FDA for SENTI-202, an investigational allogeneic chimeric antigen receptor natural killer (CAR-NK) cell therapy candidate intended to treat r/r acute myeloid leukemia (AML) and myelodysplastic syndrome. The RMAT designation specifically applies to treating adults with r/r AML. Notably, SENTI-202 received orphan drug designation from the FDA earlier in 2025. “Leveraging our Logic Gate technology, SENTI-202 has continued to demonstrate its ability to aggressively kill cancer cells while protecting normal cells for hard-to-treat cancers such as AML, a central challenge in oncology,” Kanya Rajangam, MD, PhD, the chief Medical Officer of Senti Biosciences, said in a statement. “We view the FDA’s decision to grant RMAT and orphan drug designations to SENTI-202 as major milestones for the AML patient community and we look forward to working with regulators to develop this potentially first-in-class treatment as quickly as possible and to accelerate a paradigm shift in how we treat other difficult cancers.”

6. First Patient Treated in Frontline Trial for CREATE Medicines' In Vivo CAR-T MT-303

CREATE Medicines has dosed the first patient in a phase 1 clinical trial (NCT06478693) evaluating MT-303, an in vivo CAR-T product, as a first-line treatment for metastatic hepatocellular carcinoma (HCC). Notably, the trial is assessing MT-303 along with a regimen that also includes standard of care treatments atezolizumab and bevacizumab. “New modalities capable of expanding the benefit of the current treatment options for HCC are urgently needed,” Vladimir Andelkovic, MD, FRACP, the principal investigator at ICON Cancer Centre in Brisbane, Australia, said in a statement. “Adding the immune engagement potential of MT-303 to atezolizumab and bevacizumab in frontline systemic therapy, where immune fitness is more preserved, is both scientifically compelling and potentially clinically meaningful.”