AzTrials
AzTrials

CLL/SLLPhase 1NCT05665062

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

A Phase 1 study testing SYNCAR-001, STK-009 and Cyclophosphamide in people with CLL/SLL and NHL, run by Synthekine at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
CLL/SLL, NHL, Mantle Cell Lymphoma
What is being tested?
SYNCAR-001, STK-009 and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
4 sitesUnited States
Study dates
23 Apr 2023to Nov 2041
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Selected Inclusion Criteria:

  1. Histologically confirmed relapsed/refractory hematologic malignancies, including Chronic Lymphocytic Lymphoma (CLL/SLL) and selected Non-Hodgkin's Lymphoma (NHL)
  2. Prior or current documentation of CD19 expression or high likelihood of CD19 expression based on disease histology
  3. 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

Selected Exclusion Criteria:

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Roswell Park

    Buffalo, New York, 14263

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • City of Hope

    Duarte, California, 91010

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: 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

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

Read the 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.

Being tested
SYNCAR-001, STK-009, Cyclophosphamide, Fludarabine
Keywords
CART, CD19-CART, Chimeric antigen receptor, IL-2
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYNCAR-001Drug

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

  • STK-009Drug

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

  • CyclophosphamideDrug

    lymphodepletion

  • FludarabineDrug

    lymphodepletion

Study groups in NCT05665062
Study groupRoleWhat they receive
SYNCAR-001 + STK-009 Cohort AExperimentalDose 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
Receives: Drug: SYNCAR-001; Drug: STK-009; Drug: Cyclophosphamide; Drug: Fludarabine
SYNCAR-001 + STK-009 Cohort BExperimentalDose 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
Receives: Drug: SYNCAR-001; Drug: STK-009

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Adverse events

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

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

Secondary outcomes (7)

  1. Objective response rate (ORR)

    The ORR to treatment with SYNCAR-001 + STK-009

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

  2. Duration of Response (DOR)

    To evaluate the duration of anti-cancer response after SYNCAR-001 + STK-009 administration.

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

  3. 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.

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

  4. Area under the curve (AUC)

    The quantification of the cumulative amount of drug over time.

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

  5. Maximum Concentration (Cmax)

    To identify the maximum (peak) drug concentration dosing.

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

  6. Time of maximum concentration

    The time to reach maximum (peak) drug concentration after dosing.

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

  7. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2022
  2. Study start23 Apr 2023
  3. Primary completion24 Jun 2028 (estimated)
  4. Study completionNov 2041 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05665062
Sponsor's protocol ID
STK-009-101
Status last verified
Jun 2026
First submitted
8 Dec 2022
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SYNCAR-001, STK-009 and Cyclophosphamide in people with CLL/SLL and NHL, run by Synthekine at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days post infusion (SYNCAR-001+STK-009)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05665062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in