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Engineered immune cells take on tough T-Cell cancers in new trial

NCT ID NCT07244380

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new treatment called S101 CAR-T cells for people with a type of T-cell cancer (T-LBL/ALL) that has come back or not responded to standard therapy. The treatment uses a patient's own immune cells, modified in a lab to better recognize and attack cancer cells. The main goal is to see if the cancer shrinks or disappears three months after treatment. About 38 participants will be enrolled.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 38 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Jun 2028

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 to 75 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: * 1.The subject or guardian must provide voluntary informed consent; 2.Heavily pretreated patients with relapsed or refractory T-LBL/ALL who lack effective therapeutic alternatives; 3.At screening, CD7 positivity of tumor cells must be documented by flow cytometry (on bone marrow or peripheral blood samples) and/or by immunohistochemistry (IHC) confirming CD7 expression on an extramedullary lesion biopsy; 4.If malignant cells are detected in the peripheral blood at screening, they must demonstrate a CD4-negative and CD8-negative (double-negative) immunophenotype as assessed by flow cytometry; 5.Male or female subjects, aged 18 to 75 years (inclusive); 6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; 7.Estimated survival time\>12 weeks. Exclusion Criteria: * 1.Patients with a history of allogeneic hematopoietic stem cell transplantation within the past 6 months are excluded; 2.Active or uncontrolled infection requiring systemic treatment at screening, excluding mild genitourinary and upper respiratory infections; 3.Participation in another clinical trial within 4 weeks prior to signing the informed consent form (ICF), OR the date of ICF signing occurring within 5 half-lives of the last dose from a previous investigational drug trial (whichever timeframe is longer); 4.Patients with previous treatment involving CAR-T cells or other gene-modified cell therapies are excluded; 5.Patients with acute GVHD (aGVHD) or moderate-to-severe chronic GVHD (cGVHD) within 4 weeks prior to screening, or those who have received systemic pharmacologic therapy for GVHD within 4 weeks prior to infusion; 6.Patients who have received extensive radiotherapy within 4 weeks prior to ICF signing, with the exception of non-target lesion radiotherapy administered for symptomatic palliation that may be permitted during the study period; 7.Women who are pregnant or lactating; 8.Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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

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  2. A doctor treating you

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