Immune cell therapy shows promise for tough lymphoma cases
NCT ID NCT03029338
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a personalized cell therapy called CD19 CAR T cells in 20 adults with relapsed or refractory B-cell lymphoma. The treatment involves taking a patient's own immune cells, engineering them to recognize and attack cancer cells, and infusing them back. The main goals were to check safety and see if the cells could 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
- CD19 CAR T cells (a type of immune cell therapy)
- What this could lead to
- If successful, this could point toward a new treatment option for people with hard-to-treat B-cell lymphoma.
- What could go wrong
- This is a very early Phase 1 trial with only 20 participants, so results may not apply to everyone. Side effects from CAR T therapy can be serious.
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
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20 people
The number who actually took part.
- Started
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Jun 2017
- Finished
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Jun 2021
- 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 to 70 years
- Sex
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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: * Patients aged 18 to 70 years with relapsed or refractory CD19 positive B-cell lymphoma. * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. * Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal(ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 40ml/min. * Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study. * Patients should sign informed consent form. Exclusion Criteria: * Patients with central nervous system involvement by lymphoma. * Prior chemotherapy within 2 weeks before enrollment with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine and thioguanine are permitted within 2 weeks of enrollment as maintenance or to reduce tumor load. * Prior allogeneic hematopoietic stem cell transplant (HSCT) ≤ 4 months before enrollment. Patients must have completed immunosuppression therapy prior to enrollment. At enrollment, patients must not have≥ grade 2 acute GVHD, or either moderate or severe limited chronic GVHD, or extensive GVHD of any severity. * Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease). * Major surgery within 4 weeks before enrollment. * Impaired cardiac function:Ejection fraction ≤45 % on MUGA scan. QTc interval \> 450msecs on baseline ECG. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias). * Administration of live vaccine ≤ 4 weeks before enrollment. * Other concurrent severe and/or uncontrolled medical conditions: Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
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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
-
Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020, China
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