Experimental Two-Pronged immune therapy tackles tough lymphoma

NCT ID NCT05149391

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new cell therapy called C-CAR039 in 3 adults with B-cell non-Hodgkin's lymphoma that had come back or stopped responding to treatment. The therapy uses a patient's own immune cells, modified to target two proteins (CD19 and CD20) on cancer cells. The main goal was to check safety and find the right dose, with early signs of effectiveness also tracked.

What this could mean

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

Active substance
C-CAR039 (a type of immune cell therapy that targets two proteins on cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for patients with hard-to-treat B-cell lymphoma.
What could go wrong
This is a very early phase 1 trial with only 3 participants, so results may not apply broadly. Side effects from CAR T-cell therapy can be severe, including cytokine release syndrome.

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

3 people

The number who actually took part.

Started

Jul 2021

Finished

May 2024

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 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: 1. The patient volunteered to participate in the study and signed the Informed Consent; 2. Age, 18-70 years (include 18 and 70), male or female; 3. Expected survival ≥ 12 weeks 4. Eastern Cooperative Oncology Group score 0-2 5. CD19 or CD20 positive B-Non-Hodgkin's lymphoma confirmed by cytology or histology according to World Health Organization 2016 criteria; 6. Patients with a clear diagnosis of relapsed and/or refractory B-Non-Hodgkin's lymphoma, including Diffuse Large B Cell Lymphoma, Follicular Lymphoma and Mantle Cell Lymphoma. Diffuse Large B Cell Lymphoma includes the following types: 1. Diffuse Large B Cell Lymphoma, Non Specifically 2. Primary Mediastinal B-cell Lymphoma 3. Transformed Follicular Lymphoma 4. High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 5. High Grade B-Cell Lymphoma, Non Specifically 7. For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded; 8. No contraindications of apheresis. 9. At least one measurable lesion according to Lugano 2014 criteria; 10. Adequate organ function and adequate bone marrow reserve 1. Hemoglobin≥80 g/L 2. Absolute neutrophil count≥1.0×109/L 3. Platelet≥50×109/L, 4. Creatinine≤1.5×upper limit of the normal range (ULN) 5. Cardiac ejection fraction≥50% 6. Saturation of Pulse Oxygen\>92% 7. Total bilirubin≤1.5×ULN 8. Alanine Aminotransferase/Aspartate Aminotransferase≤3×ULN Exclusion Criteria: 1. Malignant tumors other than B-Non-Hodgkin's lymphoma within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery; 2. Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus or treponema pallidum infection ; 3. Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need treatment; 4. Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion; 5. Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment; 6. Patients who have been previously infected with tuberculosis; 7. Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of C-CAR039; 8. Patients with central nervous system involvement;

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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.

Contacts and locations

Locations

  • Peking University Cancer Hospital

    Beijing, China

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