Double attack on lymphoma: antibody plus CAR-T combo shows promise
NCT ID NCT06464185
First seen Jun 24, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests a two-step treatment for people with relapsed or refractory B-cell Non-Hodgkin lymphoma. First, patients receive a bispecific antibody therapy (Obinutuzumab and Glofitamab) to help the immune system attack cancer cells. Then, they get an infusion of CD19-CAR T cells, which are specially engineered immune cells. The goal is to see if this combination is safe and improves response rates. About 48 participants will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Obinutuzumab, Glofitamab, and CD19-CAR T cells
- What this could lead to
- If successful, this could offer a more effective treatment option for patients with hard-to-treat B-cell lymphoma that has returned after prior therapies.
- What could go wrong
- This is an early-phase trial with only 48 participants, so results may not apply broadly. The combination therapy carries risks of serious side effects like immune reactions and infections.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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53 people
The number who actually took part.
- Started
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Apr 2024
- 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 to 80 years
- 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: * The patient has fully understood the study and voluntarily signed the informed consent form (ICF) * Must meet the diagnostic criteria for relapsed and refractory B-NHL and have evaluable disease lesions, in addition to the following characteristics for different types of B-NHL: A, Diffuse large B-cell Lymphoma: Patients with histologically confirmed DLBCL; Patients who must have received ,anthracyclines CD20 monoclonal antibodies and BTK inhibitors and other Drug therapy, and have received at least two lines of treatment and relapsed, not relieved or progressed within 24 months after the last line of treatment; B, Relapsed and Refractory Follicular lymphoma (FL): Tissue Biopsy proved FL: grade 1-3a; Must have received anthracyclines and CD20 monoclonal antibody Drug therapy, and have received at least two lines of treatment and relapsed, not remitted or progressed within 24 months after the last line of treatment; C, Relapsed and Refractory Marginal zone lymphoma (MZL): Histologically unequivocally confirmed MZL; Must have received anthracyclines and CD20 monoclonal antibody Drug therapy, and have received at least two lines of treatment and relapsed, not remitted or progressed within 24 months after the last line of treatment; D, Relapsed and refractory Mantle cell lymphoma (MCL): Histologically confirmed MCL; Relapsed or refractory after at least 2 lines of therapy (including anti-CD20 monoclonal antibody, anthracyclines or bendamustine, and BTKi); E, Relapsed and refractory CLL: Histologically confirmed CLL; Patients who have received at least Immunochemotherapy and have Drug therapy to both BTK inhibitors and BCL2 inhibitors Drug resistance; F, Relapsed and refractory WM: Patients with histologically confirmed WM; Patients who must have received anthracyclines, CD20 monoclonal antibodies and BTK inhibitors and other Drug therapy, and have received at least two lines of treatment and relapsed, not relieved or progressed within 24 months after the last line of treatment; * ECOG score 0-1 * Laboratory test: Neutrophils 0.5 x 10 \^ 9/L; platelets 30 x 10 \^ 9/L; Bilirubin total 2 x upper limit; GPT/Glutamic-oxaloacetic transferase 3 x upper limit. Creatinine clearance ≥ 30 mL/min. * The expected survival time of patients is ≥ 6 months; Exclusion Criteria: * Neoplasm malignant other than B-NHL (except active central nervous system lymphoma) diagnosed or treated within the past year; Patients who received anti Neoplasm therapy (including chemotherapy, targeted therapy, hormone therapy, traditional Chinese medicine with anti neoplasm activity, etc.) or participated in other clinical trials and received the investigational drug within 4 weeks before the first use of the investigational drug; * Liver renal impairment not related to lymphoma: GPT (ALT) \> 3 times the upper limit of normal, glutamic-oxaloacetic transferase (AST) \> 3 times the upper limit of normal, bilirubin total (TBIL) \> 2 times the upper limit of normal, serum creatinine clearance rate \< 30ml/min; * Other serious medical diseases that will affect the study (such as uncontrolled Diabetes mellitus, gastric ulcer, other serious heart lung disease, etc.), and the right to decide belongs to the investigator. * Cardiac function and disease meet one of the following conditions: A, Long QTc syndrome or QTc interval \> 480 MS; B, Complete left bundle branch block, grade II or III AV block; C, Serious, uncontrolled arrhythmia requiring drug therapy; D, New York Heart Association Heart disorder grade ≥ III; E, Cardiac Ejection Fraction (LVEF) less than 50%; F, Ischaemia, unstable Angina pectoris, history of severe unstable Ventricular arrhythmia or any other Arrhythmia requiring treatment, history of clinically significant Pericardial disease, or Electrocardiogram evidence of acute Myocardial infarction or active conduction system abnormalities within 6 months prior to recruitment; * Known history of Infection human Immunodeficiency virus (HIV) or active Hepatitis B virus (HBV) Infection, or any uncontrolled active Injection requiring intravenous Systemic infection of antibiotics; Patients in the past 14 days received a large surgery (excluding lymph node Biopsy) or expected treatment in the need for a large Surgery; * Previous or current other neoplasm malignant (except effectively controlled skin Basal cell carcinoma without melanoma, breast/In situ cancer of cervix, and other effectively controlled Neoplasm malignant without treatment within the past five years * Pregnancy or lactating women, women of childbearing age who did not take contraception measures; * Hypersensitivity to the drugs or ingredients used;
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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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Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
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Other studies related to the condition(s) this trial covers.
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