Engineered immune cells take on tough lymphoma
NCT ID NCT05757700
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new type of CAR T-cell therapy for adults with B-cell lymphoma that has come back or not responded to treatment. The therapy uses a patient's own immune cells, modified to better target and kill cancer cells. The study aims to find the safest dose and see if it can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- genetically modified T cells (CAR T cells) targeting CD19
- What this could lead to
- If it works, this could offer a new treatment option for people with hard-to-treat B-cell lymphoma.
- What could go wrong
- This is an early phase 1 trial with only 30 participants, so it's too soon to know if it will work. There may be side effects like 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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 ≥ 18 years of age * Creatinine ≤1.5 mg/100 ml or creatinine clearance ≥ 45ml/min/m2 , direct bilirubin ≤2.0 mg/100 ml, AST and ALT ≤3.0x upper limit of normal (ULN) * Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry. * Histologically confirmed DLBCL and large B cell lymphoma, including * DLBCL, not otherwise specified (NOS), or * Transformed DLBCL from follicular lymphoma, or * High-grade B cell lymphoma (excluding Burkitt's lymphoma), or * Primary mediastinal large B cell lymphoma AND * Chemotherapy refractory disease, defined as a failure to achieve at least a partial response or disease progression within 12 months to the last therapy, OR * Disease progression or recurrence in ≤12 months of prior autologous stem cell transplant (ASCT), OR * Relapsed disease after 2 or more prior chemoimmunotherapies with at least one containing an anthracycline and CD20 directed therapy * Patients need to have radiographically documented disease Exclusion Criteria: * ECOG performance status ≥2. * Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished. * Active CNS disease * Impaired cardiac function (LVEF \<40%) as assessed by ECHO or MUGA scan. * Patients with the following cardiac conditions will be excluded: * New York Heart Association (NYHA) stage III or IV congestive heart failure * Myocardial infarction ≤6 months prior to enrollment * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration ≤6 months prior to enrollment * Patients with HIV or active hepatitis B or hepatitis C infection are ineligible. * Patients with prior allogeneic hematopoietic stem cell transplant are eligible, if more than 3 months from transplant and if patients have no active graft versus host disease (GvHD) and not on systemic immunosuppressive therapy. * Prior CD19-directed therapy including commercially approved or investigational CD19 CAR T cells or BiTEs is allowed, as long as expression of CD19 is confirmed by flow cytometry or immunohistochemistry. * Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible. * Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin. * Patients with presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible. * Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.
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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
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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
- A CAR-T therapy given by injection: can it help Hard-to-Treat lymphoma?
- New antibody tested against aggressive blood cancer
- Can engineered immune cells beat tough B-Cell cancers?
- Can engineered immune cells lock in remission for aggressive lymphoma?
- Can a single injection create Cancer-Fighting cells inside the body?