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

NCT07823829 | Recruiting Phase 1

• 1 other identifier: CT1190B-LBCL-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Large B-Cell Lymphoma (LBCL)

Outcome Measures

Primary Outcomes (6)

• treatment-emergent adverse events (TEAE),

  Infusion until 12 months

• treatment-related adverse events (TRAE)

  Infusion until 12 months

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

  Infusion until 12 months

• Dose limiting toxicity (DLT)

  Infusion until 12 months

• maximum tolerated dose (MTD

  Infusion until 12 months

• recommended phase 2 dose (RP2D)

  Infusion until 12 months

Secondary Outcomes (14)

• ORR

  Infusion up to 12 months

• Objective response rate (ORR) at 12 weeks

  Infusion until 12 weeks

• CRR

  Infusion up to 12 months

• DOR

  Infusion up to 12 months

• TTR

  Infusion up to 12 months

Study Arms (1)

CT1190B

EXPERIMENTAL

Drug: CT1190B intravenous infusion

Interventions

CT1190B intravenous infusion DRUG

68 subjects received 1190B injection for infusion

CT1190B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• UCARsgen Biotech Limited: lead

Study Sites (3)

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

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

Central Study Contacts

Lifeng Zhang Operations Director

CONTACT

021-64501828; lifengzhang@carsgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 16, 2026
• Study Start: September 13, 2026
• Primary Completion (Estimated): September 14, 2028
• Study Completion (Estimated): September 14, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

CN (3)