SY-307
/ Syena, UT MD Anderson Cancer Center
- LARVOL DELTA
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April 23, 2025
Phase I dose escalation and expansion study of PRAME T-cell receptor (TCR) engineered IL15-transduced cord blood–derived natural killer (NK) cells in patients with recurrent and/or refractory melanoma (PRAMETIME-Mel).
(ASCO 2025)
- P1 | "Enrolled patients will receive lymphodepletion chemotherapy (fludarabine 30 mg/m2 and cyclophosphamide 500 mg/m2) on days -6 to -3, followed by a single dose of PRAME TCR/IL-15 NK cells on day 0. Longitudinal blood and tissue samples will be collected for correlative immune analysis."
Clinical • P1 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • IL15 • IL2 • PRAME
May 05, 2025
Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)
(clinicaltrials.gov)
- P1 | N=39 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Recruiting
Enrollment open • Melanoma • Oncology • Solid Tumor
February 28, 2025
Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)
(clinicaltrials.gov)
- P1 | N=39 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Active, not recruiting
Enrollment closed • Melanoma • Oncology • Solid Tumor
October 04, 2024
Phase I dose escalation and expansion study of PRAME T-cell receptor engineered IL15-transduced cord blood-derived natural killer cells in patients with recurrent/refractory melanoma (PRAMETIME-Mel)
(SITC 2024)
- "Enrolled patients will receive lymphodepletion chemotherapy (fludarabine 30 mg/m2 and cyclophosphamide 500 mg/m2) on days -6 to -3, followed by a single dose of PRAME TCR/IL-15 NK cells on day 0 (figure 1). Longitudinal blood and tissue samples will be collected for correlative immune analysis."
Clinical • P1 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • IL15 • IL2 • PRAME
October 28, 2024
Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)
(clinicaltrials.gov)
- P1 | N=39 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center
New P1 trial • Melanoma • Oncology • Solid Tumor
September 20, 2024
Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies
(clinicaltrials.gov)
- P1/2 | N=54 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Recruiting
Enrollment open • Oncology
August 09, 2024
Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies
(clinicaltrials.gov)
- P1/2 | N=54 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting
Enrollment closed • Oncology
June 27, 2024
Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies
(clinicaltrials.gov)
- P1/2 | N=54 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2024 ➔ Jun 2024
Enrollment open • Trial initiation date • Oncology
April 25, 2024
Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies
(clinicaltrials.gov)
- P1/2 | N=54 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center
New P1/2 trial • Oncology
April 30, 2024
Replay and MD Anderson announce FDA clearance of IND application for first-in-class PRAME-targeted T-Cell Receptor Natural Killer (TCR-NK) cell therapy for hematological malignancies
(GlobeNewswire)
- "Replay...and The University of Texas MD Anderson Cancer Center, today announced that the Food & Drug Administration (FDA) has issued a ‘safe to proceed’ for the Investigational New Drug (IND) application for PRAME TCR/IL-15 NK (SY-307), an engineered T-Cell Receptor Natural Killer (TCR-NK) cell therapy for relapsed/refractory myeloid malignancies. MD Anderson is the IND sponsor....The phase 1/2 open-label study will assess the safety, tolerability, and preliminary efficacy of PRAME TCR/IL-15 NK (SY-307) in patients with relapsed/refractory AML and MDS....Up to 44 patients will be enrolled into the study, which is anticipated to commence in Q3 2024."
IND • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology
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