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Immune cell therapy shows promise for aggressive blood cancer

NCT ID NCT04661020

Disease control Sponsor: Zhejiang University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 treatment called CD19 CAR-T therapy for people newly diagnosed with a fast-growing type of blood cancer called high-risk large B-cell lymphoma. The therapy uses a patient's own immune cells, modified to better attack cancer cells. The main goal is to see how many patients achieve complete remission three months after treatment.

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 40 people

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

Started

Dec 2020

Expected to finish

Dec 2026

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

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.

Inclusion Criteria: 1. Age no less than 18, no gender limit; 2. Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified; 3. Confirmed CD19 and CD20 postive expressions in lymphoma cells 4. ECOG score 0-2; 5. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 6. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 7. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%; 8. Estimated survival time ≥ 3 months; 9. Patients or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: 1. Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 4. Active infection of hepatitis B virus or hepatitis C virus; 5. Previously treated with any CAR-T cell product or other genetically modified T cell therapies; 6. Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (\<5 times) ; 7. Other uncontrolled diseases that were not suitable for this trial; 8. Patients with HIV infection; 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

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Conditions

The condition(s) this trial relates to.

large B-cell lymphoma

As listed by the trial registrant

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

Large B-cell lymphoma (LBCL)

How to take part

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

  1. The places running it

    1 site. 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

  • The First Affiliated Hospital，College of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

More trials for these conditions

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