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Active Not RecruitingNCT05665062

Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies

A Phase 1 Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) in Subjects With Relapsed or Refractory CD19+ Hematologic Malignancies

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
36 (estimated)
Sponsor
Synthekine · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.

Detailed description

SYNCAR-001 + STK-009 is a 2-component human orthogonal (ho) IL-2 receptor-ligand cell therapy consisting of (1) SYNCAR-001, a CD19-directed chimeric antigen receptor T cell (CAR-T) co-expressing an engineered IL-2 beta receptor (hoRb); and (2) STK-009, an engineered pegylated IL-2 cytokine (hoIL-2) selective for hoRb. The study will follow a 3+3 design during dose escalation. Cohort A will enroll subjects to SYNCAR-001 + STK-009 with lymphodepletion. At Dose Level 3, a separate dose escalation cohort will be introduced to enroll subjects to SYNCAR-001 + STK-009 without lymphodepletion (Cohort B). Subsequent dose expansions will enroll subjects at the RP2D for each cohort.

Conditions

Interventions

TypeNameDescription
DRUGSYNCAR-001SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb
DRUGSTK-009STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb
DRUGCyclophosphamidelymphodepletion
DRUGFludarabinelymphodepletion

Timeline

Start date
2023-04-23
Primary completion
2026-06-24
Completion
2026-11-01
First posted
2022-12-27
Last updated
2025-04-06

Locations

4 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05665062. Inclusion in this directory is not an endorsement.