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- || anti-CD33 CAR T / City of Hope, National Cancer Institute
P1 data, Preclinical, Journal: Development of a workflow for in vitro on- and off-target cytotoxicity assessment of CAR T cell therapies to support first-in-human clinical trials: An orthogonal approach using human induced pluripotent stem cell-derived cells as a surrogate for normal vital organ systems. (Pubmed Central) - Jun 16, 2025
Experimental considerations including assay and cell model qualification are presented, and an orthogonal workflow described. Finally, an illustrative case of experimental CD33 CAR T cells co-cultured with a select panel of hiPSC-derived normal cells serves as a springboard for other CAR T cell developers to consider in their nonclinical safety programs.
- tremtelectogene empogeditemcel (VOR33) / Vor Biopharma
A CD33-DELETED ALLOGRAFT (TREM-CEL) ENABLES GEMTUZUMAB OZOGAMICIN MAINTENANCE POST-HEMATOPOIETIC CELL TRANSPLANT WITH THERAPEUTIC EXPOSURES AND LOW TOXICITY IN PATIENTS WITH ACUTE MYELOID LEUKEMIA (Coral 4+5) - May 15, 2025 - Abstract #EHA2025EHA_3477;
P1/2
GO exposures correlate with higher doses seen in R/R AML patients, likely due to reduction CD33-mediated clearance and supports an increased therapeutic window. These data support safe and effective administration of GO after trem-cel HCT, enabling repeated maintenance dosing intended to reduce relapse risk.
- | anti-CD33 CAR T / City of Hope, National Cancer Institute
Trial completion date: CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Feb 6, 2025
P1, N=27, Recruiting, Sponsor: City of Hope Medical Center
These data support safe and effective administration of GO after trem-cel HCT, enabling repeated maintenance dosing intended to reduce relapse risk. Trial completion date: Sep 2026 --> Sep 2028
- anti-CD33 CAR T / City of Hope, National Cancer Institute
Autologous CD33CART for Children and Adolescents/Young Adults with Relapsed/Refractory AML: Phase 1/2 Clinical Trial Correlative Biology Analyses Demonstrate Potent in Vitro, In Vivo, and Ex Vivo Anti-Leukemia Activity (Grand Hall C (Manchester Grand Hyatt San Diego)) - Nov 6, 2024 - Abstract #ASH2024ASH_1592;
P1/2
Additional laboratory studies to elucidate potentially deleterious T cell- or AML-intrinsic and microenvironmental factors are in process. The trial is now accruing in an allogeneic arm using hematopoietic stem cell transplant donor-derived T cells.
- anti-CD33 CAR T / City of Hope, National Cancer Institute, CD33CART / Center for International Blood and Marrow Transplant Research
Success of Centralized Manufacturing of CD33 CAR T-Cells (CD33CART) for Children and Young Adults with Relapsed/Refractory AML () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_858;
P1/2
Despite wide inter-patient heterogeneity of apheresis products, centralized manufacturing of CD33CART was feasible in children and young adults with r/r AML. Correlative analyses characterizing CD33CART products are ongoing.
- | anti-CD33 CAR T / City of Hope, National Cancer Institute
Trial completion date, Trial primary completion date: CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Nov 29, 2023
P1, N=27, Recruiting, Sponsor: City of Hope Medical Center
Correlative analyses characterizing CD33CART products are ongoing. Trial completion date: Nov 2025 --> Sep 2026 | Trial primary completion date: Nov 2025 --> Sep 2026
- anti-CD33 CAR T / City of Hope, National Cancer Institute, CD33CART / Center for International Blood and Marrow Transplant Research
CD33 CAR T-Cells (CD33CART) for Children and Young Adults with Relapsed/Refractory AML: Dose-Escalation Results from a Phase I/II Multicenter Trial (SDCC - Room 6CF) - Nov 3, 2023 - Abstract #ASH2023ASH_4898;
P1/2
CD33CART expansion was best in subjects treated at DL4 (1 x 10 7 /kg) with MRD negative CRs and transient myeloid aplasia occurring in 2 of 5 (40%) subjects evaluable for response (Table). Based on early clinical efficacy at DL4, enrollment continues in the phase 2 portion.
- | anti-CD33 CAR T / City of Hope, National Cancer Institute
Enrollment open, Trial initiation date: CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Jun 15, 2023
P1, N=27, Recruiting, Sponsor: City of Hope Medical Center
Based on early clinical efficacy at DL4, enrollment continues in the phase 2 portion. Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Aug 2023
- decitabine / Generic mfg.
Combining Anti-CD33 Chimeric Antigen-Receptor T Cells with the Hypomethylating Agent Decitabine to Treat Acute Myeloid Leukemia (Room 403 AB) - May 3, 2023 - Abstract #ASGCT2023ASGCT_2366;
Moreover, DAC treatment resulted in downregulation of DNA repair pathways, ?-Catenin, and Notch signaling pathways.Taken together, we found that the antileukemia activity of CD33 CAR T cells was enhanced by pretreatment of leukemia cells with DAC. This combination represents a clinically relevant therapy for the treatment of patients with r/r AML.
- anti-CD33 CAR T / City of Hope, National Cancer Institute
CD33 CAR T Cells Generated by Restrained TCR Stimulation and Optimized Cytokines Manifested Potent Antileukemic Activity and Less-Differentiated Memory Phenotype (Board No. 1666) - Apr 6, 2023 - Abstract #ASGCT2023ASGCT_898;
Our previous clinical trial of CD123 CAR T cells was promising but identified the need for a faster CAR T cell manufacturing process. Using a combination of restrained TCR stimulation (4D-2:1 bead) and IL2/IL15 cytokines, we optimized our CD33 CAR T cell production platform to yield highly proliferative CAR T cells with less-differentiated memory phenotype and potent antigen-dependent antileukemic efficacy.
- | anti-CD33 CAR T / City of Hope, National Cancer Institute
New P1 trial: CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - Jan 5, 2023
P1, N=27, Not yet recruiting, Sponsor: City of Hope Medical Center