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ACTIVE NOT RECRUITING Phase 1

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

NCT05665062 · View on ClinicalTrials.gov ↗

Study Summary

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

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG SYNCAR-001
  • DRUG STK-009

Study Locations (4)

New York

  • Roswell Park — Buffalo
  • Memorial Sloan Kettering Cancer Center — New York

California

  • City of Hope — Duarte

Ohio

  • Cleveland Clinic — Cleveland

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2023-04-23
Est. Completion 2026-11
Phase Phase 1

Sponsor

Synthekine

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05665062

The ClinicalTrials.gov registry entry for NCT05665062 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Synthekine, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05665062 reports 4 study locations spanning 3 distinct geographic areas — top geographies include New York, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05665062 about?

NCT05665062 is a clinical study titled "Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies". This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.

What is the current status of trial NCT05665062?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2023-04-23. Estimated completion is 2026-11.

What conditions does trial NCT05665062 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B Cell Lymphoma, Large B-cell Lymphoma, NHL. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05665062?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), SYNCAR-001 (DRUG), STK-009 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05665062?

This trial is sponsored by Synthekine, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05665062 being conducted?

This trial has 4 study locations across California, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial