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

NCT05665062 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: STK-009-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

CLL/SLL; NHL; Mantle Cell Lymphoma; Follicular Lymphoma; Large B-cell Lymphoma; Indolent B-Cell Non-Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma

Keywords

CART; CD19-CART; Chimeric antigen receptor; IL-2

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicities (DLTs)

  Incidence of adverse events (AEs) meeting protocol defined DLT criteria and determination of the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of STK-009 in combination with a fixed dose of SYNCAR-001

  Up to 28 days post infusion (SYNCAR-001+STK-009)

• Adverse events

  Assess the safety and tolerability of STK-009 in combination with SYNCAR-001 by review of AEs

  Up to 24 months post infusion (SYNCAR-001+STK-009)

Secondary Outcomes (7)

• Objective response rate (ORR)

  Up to 24 months post infusion (SYNCAR-001+STK-009)

• Duration of Response (DOR)

  Up to 24 months post infusion (SYNCAR-001+STK-009)

• Progression Free Survival (PFS)

  Up to 24 months post infusion (SYNCAR-001+STK-009)

• Area under the curve (AUC)

  Up to 24 months post infusion (SYNCAR-001+STK-009)

• Maximum Concentration (Cmax)

  Up to 24 months post infusion (SYNCAR-001+STK-009)

Study Arms (2)

SYNCAR-001 + STK-009 Cohort A

EXPERIMENTAL

Dose escalation: A single fixed dose of autologous SYNCAR-001 CAR-T intravenously (IV) will be administered in combination with repeated sequential ascending doses of STK-009 subcutaneously (SC) Dose expansion: A single fixed dose of autologous SYNCAR-001 CAR-T IV will be administered in combination with repeated doses of STK-009 SC at the RP2D

Drug: SYNCAR-001; Drug: STK-009; Drug: Cyclophosphamide; Drug: Fludarabine

SYNCAR-001 + STK-009 Cohort B

EXPERIMENTAL

Dose escalation: A single fixed dose of autologous SYNCAR-001 CAR-T intravenously (IV) will be administered in combination with repeated sequential ascending doses of STK-009 subcutaneously (SC) Dose expansion: A single fixed dose of autologous SYNCAR-001 CAR-T IV will be administered in combination with repeated doses of STK-009 SC at the RP2D

Drug: SYNCAR-001; Drug: STK-009

Interventions

SYNCAR-001 DRUG

SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb

SYNCAR-001 + STK-009 Cohort A; SYNCAR-001 + STK-009 Cohort B

STK-009 DRUG

STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb

SYNCAR-001 + STK-009 Cohort A; SYNCAR-001 + STK-009 Cohort B

Cyclophosphamide DRUG

lymphodepletion

SYNCAR-001 + STK-009 Cohort A

Fludarabine DRUG

lymphodepletion

SYNCAR-001 + STK-009 Cohort A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed relapsed/refractory hematologic malignancies, including Chronic Lymphocytic Lymphoma (CLL/SLL) and selected Non-Hodgkin's Lymphoma (NHL)
• Prior or current documentation of CD19 expression or high likelihood of CD19 expression based on disease histology
• No signs of symptoms of central nervous system (CNS) disease or detectable evidence of CNS or meningeal disease on magnetic resonance imaging (MRI) at the time of screening

You may not qualify if:

• Prior CD19 directed therapy including CD19 CARTs
• Prior allogeneic hematopoietic stem cell transplant within 6 months of enrollment
• Prior autologous hematopoietic stem cell transplant within 6 weeks of enrollment.
• Presence of GVHD

Sponsors & Collaborators

• Synthekine: lead

Study Sites (4)

City of Hope

Duarte, California, 91010, United States

Location

Roswell Park

Buffalo, New York, 14263, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 27, 2022
• Study Start: April 23, 2023
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)