ClinicalTrials.gg
RecruitingNCT07823829CT1190BUpdated Oct 1, 2026

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

A Phase 1/2 interventional study of CT1190B intravenous infusion in Large B-Cell Lymphoma (LBCL), sponsored by UCARsgen Biotech Limited. Recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by UCARsgen Biotech Limited · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 1, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 283 studies in Lymphoma, B-Cell with a site in China — 125 open to participants now, 146 under way, 9 of them phase 3. Lymphoma, B-Cell · China.

Planned enrollment
72nd of 273
68 · median 30
Started
2026
with 25 others
Phase 1/2
58 of 283
24 open now
Primary completion
2028-09
later than 119 of 145 live
Registered
281st of 283
by date

Among the 283 studies in Lymphoma, B-Cell with a site in China, this one is the 72nd largest by planned enrollment of the 273 interventional ones that give a count, is one of 26 that started in 2026, is one of 58 in phase 1/2, reaches primary completion later than 119 of the 145 other live ones, and was the 281st registered.

Lymphoma, B-Cell

885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.

Browse Lymphoma, B-Cell studies →

Open to participants now

125 of the 283 studies in Lymphoma, B-Cell with a site in China are open now. Recruiting first, the newest first:

119 more — sign in →

All 125 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 209 Lymphoma, B-Cell studies recruiting now, 129 (62%) set no upper age limit and 60 (29%) stop at 75 or younger; 37 take children under 18; 3 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 283 studies in Lymphoma, B-Cell with a site in China, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Large B-Cell Lymphoma (LBCL)

Browse trials for

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Volunteer to participate in the clinical trial; participants fully understand and are informed of this trial and sign the form; Willing to follow and able to complete all trial procedures;
  • Age 18 \~ 75 years (inclusive);
  • 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 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 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;
  • (ECOG) performance status 0-1;
  • Participants should meet the following test results (there should be no ongoing supportive care):
  • Female participants of must have a negative pregnancy test at screening and before receiving clearing therapy, be willing to use a highly effective and reliable method of 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

Exclusion Criteria:

  • Pregnant or lactating women;
  • Presence of , syphilis infection, active virus infection, active 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 ( 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 hematopoietic stem cell transplantation within 12 weeks prior to signing the 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.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    CT1190B

    Drug: CT1190B intravenous infusion

Interventions

  • DrugCT1190B intravenous infusion

    68 subjects received 1190B injection for infusion

06

What researchers measure

Primary outcomes

  1. treatment-emergent adverse events (TEAE),

    Time frame: Infusion until 12 months

  2. treatment-related adverse events (TRAE)

    Time frame: Infusion until 12 months

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

    Time frame: Infusion until 12 months

  4. Dose limiting toxicity (DLT)

    Time frame: Infusion until 12 months

  5. maximum tolerated dose (MTD

    Time frame: Infusion until 12 months

  6. recommended phase 2 dose (RP2D)

    Time frame: Infusion until 12 months

Secondary outcomes

  1. ORR

    Time frame: Infusion up to 12 months

  2. Objective response rate (ORR) at 12 weeks

    Time frame: Infusion until 12 weeks

  3. CRR

    Time frame: Infusion up to 12 months

  4. DOR

    Time frame: Infusion up to 12 months

  5. TTR

    Time frame: Infusion up to 12 months

  6. TTCR

    Time frame: Infusion until 12 months

  7. PFS

    Time frame: Infusion up to 180 months

  8. OS

    Time frame: Infusion up to 180 months

  9. Time to maximum expansion (Tmax),

    Time frame: Infusion up to 12 months

  10. maximum expansion concentration (Cmax)

    Time frame: Infusion up to 12 months

  11. concentration-time curve (AUC)

    Time frame: Infusion up to 12 months

  12. sustained cell survival time (Tlast)

    Time frame: Infusion up to 12 months

  13. Cytokine level

    Time frame: Infusion up to 12 months

  14. Anti-drug antibody (ADA) level

    Time frame: Infusion up to 12 months

07

Study locations

1 of 3 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Sep 2028, 24 months after the start.

Of 52 non-industry phase 1/2 interventional studies under Lymphoma, B-Cell, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 82. This study's planned 24 months is below that.

Counting every sponsor, half of 94 studies reached it within 71 months; a quarter within 55 and three quarters within 96.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Sep 2026, on Oct 1, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 16, 2026
StartActual
Sep 13, 2026was Oct 2026
Primary completionEst.
Sep 14, 2028
CompletionEst.
Sep 14, 2029
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 1, 2026
Sites
3 sites changed recruiting status (2 now not yet recruiting, 1 now recruiting)
Show 3 sites
  • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine · Shanghai, Chinano status→Not yet recruiting
  • Shanghai Tongji Hospital · Shanghai, Chinano status→Recruiting
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 编辑译文 段落对照 · Hubei, Chinano status→Not yet recruiting
Oct 1, 2026
Start date
Oct 15, 2026→Sep 13, 2026 (actual)
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Not yet recruiting→Recruiting
    3 sites changed recruiting status (2 now not yet recruiting, 1 now recruiting)
    Show 3 sites
    • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine · Shanghai, Chinano status→Not yet recruiting
    • Shanghai Tongji Hospital · Shanghai, Chinano status→Recruiting
    • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 编辑译文 段落对照 · Hubei, Chinano status→Not yet recruiting
    Start date Oct 15, 2026→Sep 13, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07823829
Lead sponsor
UCARsgen Biotech Limited
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
Sep 13, 2026
Primary completion
Sep 14, 2028 (estimated)
Completion
Sep 14, 2029 (estimated)
Last update
Oct 1, 2026

Study contacts

Lifeng Zhang Operations Director
Contact
lifengzhang@carsgen.com
021-64501828

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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