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This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYNCAR-001 | Drug | SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The ORR to treatment with SYNCAR-001 + STK-009 | Up to 24 months post infusion (SYNCAR-001+STK-009) |
| Duration of Response (DOR) | To evaluate the duration of anti-cancer response after SYNCAR-001 + STK-009 administration. |
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Selected Inclusion Criteria:
Selected Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Roswell Park |
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| STK-009 | Drug | STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb |
|
| Cyclophosphamide | Drug | lymphodepletion |
|
| Fludarabine | Drug | lymphodepletion |
|
| Up to 24 months post infusion (SYNCAR-001+STK-009) |
| Progression Free Survival (PFS) | The time from the SYNCAR-001 administration date to the date of disease progression per Lugano Classification or iwCLL or death from any cause, whichever occurs earlier. | Up to 24 months post infusion (SYNCAR-001+STK-009) |
| Area under the curve (AUC) | The quantification of the cumulative amount of drug over time. | Up to 24 months post infusion (SYNCAR-001+STK-009) |
| Maximum Concentration (Cmax) | To identify the maximum (peak) drug concentration dosing. | Up to 24 months post infusion (SYNCAR-001+STK-009) |
| Time of maximum concentration | The time to reach maximum (peak) drug concentration after dosing. | Up to 24 months post infusion (SYNCAR-001+STK-009) |
| Immunogenicity | Immunogenicity will be assessed by summarizing the number of patients who develop detectable anti-STK-009 and/or anti-SYNCAR-001 anti-drug antibodies (ADAs) | Up to 24 months post infusion (SYNCAR-001+STK-009) |
| Buffalo |
| New York |
| 14263 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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