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Engineered immune cells get a boost: new combo therapy targets Hard-to-Treat blood cancers

NCT ID NCT05665062

Disease control Sponsor: Synthekine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This early-phase trial tests a new approach to treating certain blood cancers (like lymphoma and leukemia) that have come back or not responded to standard treatment. The therapy uses a patient's own immune cells, engineered to recognize and attack cancer cells (SYNCAR-001), along with a supporting drug (STK-009) designed to help those cells survive and work better. The main goal is to check the safety and find the best dose, while also looking at whether the cancer shrinks or disappears.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SYNCAR-001 (a type of CAR T-cell therapy) and STK-009 (a supporting drug)
What this could lead to
If it works, this could offer a new treatment option for people with certain blood cancers that have not responded to standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 36 participants, so it is primarily testing safety. The therapy may not work, and there are risks of serious side effects like cytokine release syndrome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Nov 2041

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic lymphocytic leukemia/small lymphocytic lymphoma diffuse large B-cell lymphoma follicular lymphoma indolent B-cell non-Hodgkin lymphoma large B-cell lymphoma mantle cell lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CLL / SLL Diffuse large B-cell lymphoma Follicular lymphoma Indolent B-cell non-Hodgkin lymphoma Large B-cell lymphoma Mantle cell lymphoma NHL

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Roswell Park

    Buffalo, New York, 14263, United States

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