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Experimental Dual-Target CAR-T therapy enters human testing for tough blood cancers

NCT ID NCT07002112

Disease control Sponsor: The First Affiliated Hospital with Nanjing Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study is testing a new gene therapy that reprograms a patient's own immune cells to attack two targets (CD19 and CD20) on cancer cells. The trial will enroll 30 adults with B-cell cancers that have come back or not responded to treatment. The main goals are to check safety, find the right dose, and see if the therapy shrinks tumors.

What this could mean

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

Active substance
CD19/CD20 dual-target CAR-T lentiviral product (a type of gene therapy that reprograms a patient's own immune cells to attack cancer cells)
What this could lead to
If successful, this could provide a new treatment option for patients with hard-to-treat B-cell cancers that have not responded to standard therapies.
What could go wrong
This is an early Phase 1 trial with only 30 participants, so safety and effectiveness are not yet proven. There is a risk of serious side effects, 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

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

Participants

About 30 people

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

Started

May 2025

Expected to finish

Jun 2029

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. Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up. 2. Age greater than or equal to 18. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. At least one evaluable tumor lesion. 5. Relapsed and/or refractory NHL , and relapsed and/or refractory CLL with treatment indications 6. Life expectancy≥ 3 months 7. Clinical laboratory values meet screening visit criteria 8. Adequate organ function; Exclusion Criteria: Subject eligible for this study must not meet any of the following criteria: 1. Prior antitumor therapy with insufficient washout period ; 2. Prior treatment with lentiviral vector-based gene therapies; 3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab). 4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator). 5. Lactating women;

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell non-Hodgkin lymphoma Recurrence

As listed by the trial registrant

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

Relapsed/refractory B-cell malignancies

How to take part

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

  1. The places running it

    6 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 Boren Hospita

    RECRUITING

    Beijing, Beijing Municipality, 102206, China

  • The First Affiliated Hospital of USTC west district

    RECRUITING

    Hefei, Anhui, 230000, China

  • The First Affiliated Hospital of ZHENGZHOU University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450000, China

  • The First Affiliated Hospital with Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430000, China

More trials for these conditions

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