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Engineered immune cells take on tough T-Cell cancers

NCT ID NCT06316427

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 CD7 CAR T-cell therapy for people with T-cell cancers that have come back or not responded to standard treatments. The therapy uses a patient's own immune cells or cells from a donor, which are modified to find and attack cancer cells. The goal is to check safety and see how well the treatment works in 80 participants.

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 80 people

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

Started

Mar 2024

Expected to finish

Mar 2028

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

1 year 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: Only patients who meet all the following criteria can be included in the group: 1. CD7-positive refractory or relapsed T-cell malignancies with progression or intolerance after all standard treatments, limited prognosis from currently available treatments and no available treatment options (e.g. HSCT or chemotherapy). 2. Tumor cells in bone marrow or cerebrospinal fluid are positive for CD7 antigen by flow cytometry or tumour tissue is positive for CD7 by immunohistochemistry (CD7 antigen positivity by flow cytometry: \>80% of tumour cells expressing CD7 with a mean fluorescence intensity \[MFI\] of CD7 similar to that of normal T cells are considered to have fully positive expression; \>80% of tumor cells expressing CD7 but with an MFI of CD7 at least 1 log lower than that of normal T cells are considered to have low expression \[dim\]; tumor cells with a CD7 expression rate between 20-80% are considered to have partial expression; CD7 antigen positivity by pathological immunohistochemistry: \>30%); 3. Male or female, age 1-70 years; 4. No severe allergic constitution; 5. Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al., 1982) of 0-2; 6. Life expectancy of at least 60 days as determined by the investigator; 7. Provide a signed informed consent form prior to any screening procedures; subjects volunteering to participate in the study should be capable of understanding and signing the informed consent form and be willing to follow the study visit schedule and associated study procedures as specified in the protocol. Subjects aged 19-70 years old need to be sufficiently aware and capable of signing the informed consent form; subjects aged 1-7 years can be recruited after legal guardians or patient advocates sign the informed consent form; subjects aged 8-18 years need to be sufficiently aware and able to sign the informed consent form, and their legal guardians or patient advocates also need to sign the informed consent form. Exclusion Criteria: Patients with at least one of the following conditions are excluded: 1. Intracranial hypertension or unconscious; 2. Acute heart failure or severe arrhythmia; 3. Acute respiratory failure; 4. Other types of malignant tumors; 5. Diffuse intravascular coagulation; 6. Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value; 7. Sepsis or other uncontrolled infection; 8. Uncontrolled diabetes mellitus; 9. Severe psychological disorder; 10. Obvious cranial lesions by cranial MRI; 11. Allergic constitution; 12. Organ recipients; 13. Pregnant or breastfeeding; 14. Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma T-cell acute lymphoblastic leukemia T-cell and NK-cell neoplasm T-lymphoblastic lymphoma

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Beijing GoBroad Hospital

    RECRUITING

    Beijing, Beijing Municipality, 102206, China

  • Shanghai Liquan Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 201418, China

  • The General Hospital of Western Theater Command PLA

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610083, China

  • Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200435, China

More trials for these conditions

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