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Engineered immune cells take aim at Hard-to-Treat T-Cell cancers

NCT ID NCT07678307

Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a new treatment called nano CD5-CAR T cells for people with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoma. The therapy uses a patient's own immune cells, modified in a lab to recognize and attack cancer cells that carry the CD5 protein. The trial has two phases: the first checks safety and the best dose, and the second looks at how well the treatment works. Participants receive chemotherapy before a single infusion of the modified cells.

What this could mean

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

Active substance
autologous nano CD5-CAR T cells
What this could lead to
If it works, this could offer a new treatment option for people with hard-to-treat T-cell cancers that have not responded to standard therapy.
What could go wrong
This is an early-phase trial with only 18 participants, so results may not apply broadly. Risks include fever, low blood pressure, and infection, and the therapy may not work for everyone.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 18 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

3 to 70 years

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.

Inclusion Criteria: * Age 3 to 70 years old * Diagnosed with CD5-positive relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) * ECOG performance status 0-2 * Adequate organ function (renal, hepatic, cardiac, pulmonary) * Able to understand and sign informed consent Exclusion Criteria: * Active severe infection or uncontrolled sepsis * History of allogeneic stem cell transplantation within 3 months * Severe autoimmune disease or immunodeficiency * Prior CD5-targeted therapy * Pregnant or breastfeeding women * Any condition that, in the investigator's opinion, would compromise safety or compliance with the protocol

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid system neoplasm Precursor T-Cell Lymphoblastic Leukemia-Lymphoma refractory hematologic cancer T-cell acute lymphoblastic leukemia T-lymphoblastic lymphoma

As listed by the trial registrant

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

Relapsed/refractory hematologic malignancies T lymphoblastic lymphoma T-cell acute lymphoblastic leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.