New CAR T-Cell combo shows promise for tough lymphoma
NCT ID NCT01840566
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether giving a patient's own genetically modified immune cells (CAR T-cells) after high-dose chemotherapy and a stem cell transplant is safe for people with aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to treatment. Seventeen adults with relapsed or refractory disease, including diffuse large B-cell lymphoma, are enrolled. The main goal is to find the safest dose of these CAR T-cells and monitor side effects.
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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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17 people
The number who actually took part.
- Start date
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Apr 2013
- Expected to finish
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Apr 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Transplant eligible patients will be eligible if criteria met per below. Inclusion Criteria: * Patients ≥ 18 years of age with aggressive B-cell non-Hodgkin lymphoma subtypes including, relapsed or refractory diffused large B-cell lymphoma (DLBCL), and transformed follicular lymphoma meeting at least one of the following criteria: * Bone marrow involvement at the time of relapse or refractory disease and not appropriate for allogeneic transplantation. * PET positive disease outside of one radiation port unless single-port disease treated with prior radiotherapy within the port, following \> or = to 2 cycles of salvage chemotherapy, still achieving chemosensitive status 1999 IWG criteria (section 12.2 and 12.383). * Creatinine ≤ 1.5 mg/100 ml (or measured 24 hour creatinine clearance of ≥ 50 cc/min) * Bilirubin \<2.0 mg/100 ml, AST and ALT \<3x the upper-limit of normal, PT and PTT \< 2x normal outside the setting of stable chronic anticoagulation therapy, * Adequate cardiac function (LVEF\>40%) as assessed by ECHO or MUGA scan performed within 1 month of treatment. * Adequate pulmonary function as assessed by DLCO of \> or = to 45% adjusted for hemoglobin. * Life expectancy of \> 3 months. Exclusion Criteria: * Karnofsky performance status ≤ 70 (see appendix VI). * Patients with other aggressive B-cell malignancies including, but not limited to: Burkitt lymphoma, transformed CLL/SLL and transformed marginal zone lymphoma that are not included in 6.1 inclusion criteria. * Patients previously treated with autologous or allogeneic bone marrow or stem cell transplantation are ineligible. * Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study. * Uncontrolled bacterial, viral or fungal infection. * Patients with HIV, active hepatitis B or hepatitis C infection.
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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 Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack (Limited protocol activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited protocol activites)
Rockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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
- Can an antibody drug boost standard chemotherapy against an aggressive blood cancer?
- A CAR-T therapy given by injection: can it help Hard-to-Treat lymphoma?