Engineered immune cells take on tough lymphoma in new trial
NCT ID NCT07319676
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a personalized CAR T-cell therapy for people with B-cell lymphoma that has come back or not responded to treatment. Patients' own immune cells are collected, modified to target cancer cells, and infused back. The trial has two phases: first to find the safest dose, then to check how well it works in 30 participants aged 10 to 80.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR T-cells (Epo-R-CD19 CAR T with or without CD22 CAR T)
- What this could lead to
- If successful, this could offer a new treatment option for patients with hard-to-treat B-cell lymphoma, potentially leading to longer remission.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply to everyone. There are risks of serious side effects like cytokine release syndrome (CRS) and neurological issues.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Oct 2040
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
-
10 to 80 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 Hide 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 * Age 10 to 80 years at screening * PET-CT measurable disease by Lugano classification (Deauville score of ≥4) and * Tissue biopsy of any tumour site and flow cytometry study of CD19 and CD22 expression. * Relapsed B-cell lymphoma after one line of systemic therapy or autologous bone marrow transplant. This includes DLBCL, PMBCL, HGBCL, DLBCL arising from indolent lymphoma, Burkitt's lymphoma/leukemia, Mantle cell lymphoma. * High risk B-cell lymphoma (BCL). High risk BCL is defined by any of the criteria below: * High-risk genetics - double/triple hit or p53mut or deletion. * IPI score ≥ 3 * Richter's transformation from chronic lymphocytic leukaemia. * Disease refractory to treatment - PET-CT positive disease after 2 courses of rituximab-containing chemoimmunotherapy. * PBMC product available * Karnofsky or Lansky score \>70. Or ECOG 0-2 * Patient expected survival is more than 3 months to allow for manufacture and release of CAR T-cells. Exclusion Criteria * Patients who test positive on urine or blood pregnancy testing and are pregnant or are lactating. * Participant of reproducible age who refuse the use of the following birth control methods if engaging in sexual activity that could lead to pregnancy. The methods include condoms, diaphragm, intrauterine device, hormonal based contraception. * Concomitant genetic syndromes associated with BM failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome with the exception of Down syndrome. * Active hepatitis B or hepatitis C within 3 months of screening. * Active HIV infection within 3 months of screening. * Grade 2 to 4 graft-vs-host disease (GVHD). * Received an investigational medicinal product within 1 month of screening. * If the total sum of CD19 and CD22 antigens expressed is less than 95.0%, patients will not be eligible. If subsequent immunophenotying of the patient's sample confirms that total sum of CD19 and CD22 antigens ≥ 95%, the patient may be rescreened. * Central nervous system: Uncontrolled seizures or status epilepticus; decreased conscious state (any cause) * Foreign patients who cannot commit to agreeable to stay in Singapore for at least 3 months post CAR T infusion and are committed to the long term monitoring post CAR T at home and in Singapore. * Prior treatment with any CAR T cell therapy (approved or investigational)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-cell lymphoma refractory are added.
Genom att skicka in godkänner du våra Användarvillkor
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
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
National University Hospital
RECRUITINGSingapore, Singapore, 119228, Singapore
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Triple drug combo targets mantle cell lymphoma
- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?
- Outpatient immunotherapy tested for hard-to-treat lymphomas