CT1190B cell therapy for relapsed/refractory large B-cell lymphoma
Official title: A Phase I/II Clinical Trial to Evaluate the Safety, Efficacy and Cellular Metabolism Kinetics of CT1190B in Patients With Relapsed/Refractory Large B-Cell Lymphoma
Run by UCARsgen Biotech Limited · NCT07823829 · Data updated 2026-11-12
This study tests CT1190B cells in adults with relapsed or refractory LBCL to see if they are safe and can help shrink tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | UCARsgen Biotech Limited Academic / other |
| Drugs / interventions | CAR-T, radiation |
| Locations | 3 sites (Shanghai, Shanghai Municipality and 2 other locations) |
| Status | Recruiting |
| Started | September 13, 2026 |
| Main results expected | September 14, 2028 |
| Study ends | September 14, 2029 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07823829 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with histologically confirmed LBCL who have relapsed or are refractory after at least two prior systemic treatments and have measurable disease.
✕Probably not a fit
Patients whose disease does not respond to CT1190B or who experience intolerable toxicity may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-phase, single-arm, open-label trial evaluating CT1190B cells given by intravenous infusion in patients with relapsed or refractory large B-cell lymphoma. The study will determine a safe dose range in Phase I and explore preliminary efficacy and cellular behavior in Phase II, including pharmacokinetics and pharmacodynamics. Eligible participants are adults 18 to 75 who have received at least two prior systemic therapies and have measurable disease; prior CD19-directed therapy requires re-testing tumor CD19/CD20 expression. The trial is conducted at selected hospitals in Shanghai, China, and is sponsored by UCARsgen Biotech Limited.
Why it matters
Potential benefit: If successful, participants may experience tumor responses and improved disease control from CT1190B therapy.
How similar studies have gone: Previous cellular therapies in LBCL have shown potential benefits in some patients, though results vary and this approach is still being explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Volunteer to participate in the clinical trial; participants fully understand and are informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures; * Age 18 \~ 75 years (inclusive); * Histologically or cytologically confirmed large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma unspecified (DLBCL, NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma(HGBL), large B-cell lymphoma (FLBL) transformed by follicular lymphoma (FL)/Grade 3b FL; * Has received at least 2 prior lines of standard systemic therapy and has relapsed after adequate treatment or meets refractory criteria. * If the participant has received prior CD19-targeted therapy, the tumor tissue should be re-collected at least 4 weeks after the last dose for CD19 and CD20 detection to confirm that the expression of CD19 or CD20 is positive; * Presence of at least one measurable lesion according to the Lugano 2014 criteria (a previously irradiated lesion is not to be considered measurable or non-measurable unless it has unequivocal progression or tumor activity after completion of radiation therapy), at least one of the following conditions is required:As measured by computed tomography (CT) or magnetic resonance imaging (MRI): nodal lesions \> 1.5 cm in long diameter or extranodal lesions \> 1.0 cm in long diameter; * Estimated survival \> 12 weeks; * Eastern Cooperative Oncology Group (ECOG) performance status 0-1; * Participants should meet the following test results (there should be no ongoing supportive care): * Female participants of child-bearing potential must have a negative pregnancy test at screening and before receiving clearing therapy, be willing to use a highly effective and reliable method of contraception within 1 year after receiving trial therapy, and absolutely prohibit egg donation within 1 year after receiving trial therapy infusion during the trial; A male participant, if sexually active with a female of childbearing potential, is willing to use a highly effective and reliable method of contraception for 1 year after receiving trial treatment. All male participants absolutely refrain from donating sperm for 1 year after receiving the trial treatment infusion during the trial. Exclusion Criteria: * Pregnant or lactating women; * Presence of HIV, syphilis infection, active hepatitis B virus infection, active hepatitis C virus infection, DNA positive (whole blood or plasma), cytomegalovirus (CMV) DNA positive; * Any uncontrollable active infection; * The toxic side effects caused by the participant's previous treatment have not recovered to the standard for adverse events (CTCAE v6.0) ≤ 1, except for hair loss and other tolerable events determined by the researcher; * Individuals with known symptomatic central nervous system (CNS) disorders or suspected involvement of CNS lymphoma; * Patients with lymphoma involving the small intestine or the muscular layers of the stomach and colon; * Received autologous hematopoietic stem cell transplantation within 12 weeks prior to signing the informed consent form; * Participants have received allogeneic hematopoietic stem cell transplantation in the past; * Participants who have previously received targeted CD19 CAR-T therapy and have tested positive for anti drug antibodies (ADA) within the last 4 weeks prior to signing the main informed consent form; * Vaccination with live or attenuated vaccines within 4 weeks prior to signing the informed consent form; * Select patients with any of the following heart diseases within the first 6 months of screening: * Blood oxygen saturation\<92% (in non oxygen state), or suffering from other serious lung diseases that the researcher has determined may endanger the patient's life by participating in the study; * Within the past 2 years, there has been a second primary malignant tumor that requires treatment or has not fully resolved; * Participants with a history of organ transplantation or waiting for organ transplantation; * Having undergone major surgical procedures within 2 weeks prior to signing the informed consent form, or planning to undergo major surgical procedures during the trial period or within 4 weeks after receiving the trial treatment (excluding local anesthesia surgeries such as cataracts); * The researchers assessed that participants were unable or unwilling to comply with the requirements of the protocol, or had other reasons that made them unsuitable to participate in this clinical trial.
Where it's running
-
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China Recruiting -
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China Not yet recruiting -
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 编辑译文 段落对照
Hubei, Wuhan, China Not yet recruiting
Study contacts
- Study coordinator: Lifeng Zhang Operations Director
- Email: lifengzhang@carsgen.com
- Phone: 021-64501828
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Academic anti-CD19 CAR-T for relapsed or refractory large B‑cell lymphoma
This project tests whether a locally manufactured anti‑CD19 CAR‑T cell therapy works and is safe for adults whose large B‑cell lymphoma has relapsed or not responded to prior treatment.
-
Pola-ZR-Glo for older patients with large B‑cell lymphoma
This trial will try combining polatuzumab vedotin, zanubrutinib, lenalidomide, and glofitamab as first-line treatment for people aged 70 and older with newly diagnosed large B‑cell lymphoma who are unfit for standard chemo or decline immunochemotherapy.
-
Adding CLS-015 to anti-CD19 CAR-T therapy for large B‑cell lymphoma during lymphodepletion
This trial tests whether giving CLS-015 (an enzyme that breaks down NETs) alongside anti‑CD19 CAR‑T therapy helps adults with large B‑cell lymphoma who have stable or progressing disease at the time of lymphodepletion.
-
Treatment with AZD0486 for patients with relapsed B-cell lymphoma
This study is testing a new treatment called AZD0486 to see if it can help adults with relapsed B-cell lymphoma feel better and stay safe after trying other therapies.
-
CD19 CAR-T therapy for B-cell non-Hodgkin's lymphoma
This study is testing a new CAR-T cell therapy for people with B-cell non-Hodgkin's lymphoma who don't want to have standard chemotherapy, to see how safe and effective it is.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.