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

September 13, 2026 updated by: UCARsgen Biotech Limited

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai Tongji Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Wuhan
      • Hubei, Wuhan, China
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 编辑译文 段落对照
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT1190B
Drug: CT1190B intravenous infusion
68 subjects received 1190B injection for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
treatment-emergent adverse events (TEAE),
Time Frame: Infusion until 12 months
Infusion until 12 months
treatment-related adverse events (TRAE)
Time Frame: Infusion until 12 months
Infusion until 12 months
•serious adverse events (SAE), and adverse events of special interest (AESI)
Time Frame: Infusion until 12 months
Infusion until 12 months
Dose limiting toxicity (DLT)
Time Frame: Infusion until 12 months
Infusion until 12 months
maximum tolerated dose (MTD
Time Frame: Infusion until 12 months
Infusion until 12 months
recommended phase 2 dose (RP2D)
Time Frame: Infusion until 12 months
Infusion until 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ORR
Time Frame: Infusion up to 12 months
Infusion up to 12 months
Objective response rate (ORR) at 12 weeks
Time Frame: Infusion until 12 weeks
Infusion until 12 weeks
CRR
Time Frame: Infusion up to 12 months
Infusion up to 12 months
DOR
Time Frame: Infusion up to 12 months
Infusion up to 12 months
TTR
Time Frame: Infusion up to 12 months
Infusion up to 12 months
TTCR
Time Frame: Infusion until 12 months
Infusion until 12 months
PFS
Time Frame: Infusion up to 180 months
Infusion up to 180 months
OS
Time Frame: Infusion up to 180 months
Infusion up to 180 months
Time to maximum expansion (Tmax),
Time Frame: Infusion up to 12 months
Infusion up to 12 months
maximum expansion concentration (Cmax)
Time Frame: Infusion up to 12 months
Infusion up to 12 months
concentration-time curve (AUC)
Time Frame: Infusion up to 12 months
Infusion up to 12 months
sustained cell survival time (Tlast）
Time Frame: Infusion up to 12 months
Infusion up to 12 months
Cytokine level
Time Frame: Infusion up to 12 months
Infusion up to 12 months
Anti-drug antibody (ADA) level
Time Frame: Infusion up to 12 months
Infusion up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCARsgen Biotech Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

September 14, 2028

Study Completion (Estimated)

September 14, 2029

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 13, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 13, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CT1190B-LBCL-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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