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Large B-Cell Lymphoma (LBCL)Phase 1/2CT1190BNCT07823829

A Phase I/II Trial of CT1190B in Patients With Relapsed/Refractory Large B-Cell Lymphoma

A Phase 1/2 study testing CT1190B intravenous infusion in people with Large B-Cell Lymphoma (LBCL), run by UCARsgen Biotech Limited at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-arm, open-label, dose-finding Phase I/II clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1190B cells in patients with R/R LBCL. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Large B-Cell Lymphoma (LBCL)
What is being tested?
CT1190B intravenous infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
3 sitesChina
Study dates
13 Sep 2026to 14 Sep 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lifeng Zhang Operations Director contact

021-64501828

lifengzhang@carsgen.com

China3 sites, 3 recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 编辑译文 段落对照

    Hubei, Wuhan

    Jia wei Chief Physician, 027-83662688, jiawei@tjh.tjmu.edu.cn

    Not yet recruiting

  • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Weili Zhao Chief Physician, 021-34186000, zwl_trial@163.com

    Not yet recruiting

  • Shanghai Tongji Hospital

    Shanghai, Shanghai Municipality

    Aibin Liang Chief Physician, 021-56051080, lab7182@tongji.edu.cn

    Recruiting

Other trials in China

About this study

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

This is a single-arm, open-label, dose-finding Phase I/II clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1190B cells in patients with R/R LBCL.

Being tested
CT1190B intravenous infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT1190B intravenous infusionDrug

    68 subjects received 1190B injection for infusion

Study groups in NCT07823829
Study groupRoleWhat they receive
CT1190BExperimentalNot described
Receives: Drug: CT1190B intravenous infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment-emergent adverse events (TEAE),

    Measured: Infusion until 12 months

  2. treatment-related adverse events (TRAE)

    Measured: Infusion until 12 months

  3. •serious adverse events (SAE), and adverse events of special interest (AESI)

    Measured: Infusion until 12 months

  4. Dose limiting toxicity (DLT)

    Measured: Infusion until 12 months

  5. maximum tolerated dose (MTD

    Measured: Infusion until 12 months

  6. recommended phase 2 dose (RP2D)

    Measured: Infusion until 12 months

Secondary outcomes (14)

  1. ORR

    Measured: Infusion up to 12 months

  2. Objective response rate (ORR) at 12 weeks

    Measured: Infusion until 12 weeks

  3. CRR

    Measured: Infusion up to 12 months

  4. DOR

    Measured: Infusion up to 12 months

  5. TTR

    Measured: Infusion up to 12 months

  6. TTCR

    Measured: Infusion until 12 months

  7. PFS

    Measured: Infusion up to 180 months

  8. OS

    Measured: Infusion up to 180 months

  9. Time to maximum expansion (Tmax),

    Measured: Infusion up to 12 months

  10. maximum expansion concentration (Cmax)

    Measured: Infusion up to 12 months

  11. concentration-time curve (AUC)

    Measured: Infusion up to 12 months

  12. sustained cell survival time (Tlast）

    Measured: Infusion up to 12 months

  13. Cytokine level

    Measured: Infusion up to 12 months

  14. Anti-drug antibody (ADA) level

    Measured: Infusion up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2026
  2. Study start13 Sep 2026
  3. Primary completion14 Sep 2028 (estimated)
  4. Study completion14 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07823829
Sponsor's protocol ID
CT1190B-LBCL-01
Acronym
CT1190B
Status last verified
Sep 2026
First submitted
8 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CT1190B intravenous infusion in people with Large B-Cell Lymphoma (LBCL), run by UCARsgen Biotech Limited at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lifeng Zhang Operations Director (021-64501828, lifengzhang@carsgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment-emergent adverse events (TEAE), (time frame: Infusion until 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07823829.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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