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CLLNCT07120633

Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL

A study testing AntiCD19 CAR-T combined with BTKi in the treatment of newly diagnosed high-risk CLL/SLL patients in people with CLL and CAR-T Cell Therapy, run by The Affiliated Hospital of Xuzhou Medical University at 1 site 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
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Trial summary

At present, there is a lack of relevant research on the first-line treatment of high-risk CLL patients with BTKi combined with CAR-T. Therefore, our center plans to conduct a study on the treatment of newly diagnosed high-risk CLL patients with AntiCD19 CAR-T combined with BTKi, in order to increase the uMRD rate of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CLL, CAR-T Cell Therapy, SLL
What is being tested?
AntiCD19 CAR-T combined with BTKi in the treatment of newly diagnosed high-risk CLL/SLL patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
1 Sep 2025to 1 Sep 2028
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient voluntarily participates and signs the informed consent form;
  • Age ≥18 years old;
  • Confirmed as CLL/SLL according to WHO standards, and confirmed positive expression of CD19 through flow cytometry or immunohistochemical detection;
  • Subjects:
  • 4.1 First-time patients who have not received systemic radiotherapy or chemotherapy in the past. (Except for the following situations: Short-term systemic corticosteroids for disease control, improvement of performance status or treatment of non-cancer indications (use for ≤14 days, prednisone <100 mg/d or dexamethasone ≤20 mg/d). Steroids must be discontinued before the study of treatment. Inhaled steroids, topical steroids and alternative corticosteroids are permitted for the treatment of asthma.
  • 4.2 Meet the treatment indications of iwCLL 2018, including: Progressive bone marrow failure caused by bone marrow infiltration due to CLL (hemoglobin <10 g/L and platelet count <100×10⁹/L); 4.3 Patients with high-risk genetic molecular factors (del(17p), TP53 gene deletion/mutation (vaf>10%), U-IGHV, complex karyotype); 4.4 Have measurable or evaluable lesions (positive peripheral blood flow results or lesions ≥1cm evaluated based on PET-CT/CT/MRI).
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  • 4.5 No contraindications for treatment with Bruton's tyrosine kinase (BTK) inhibitors or BCL2 inhibitors.
  • Good functions of major tissues and organs:
  • 5.1 Liver function: ALT/AST<3 times the upper limit of the normal value and total bilirubin ≤34.2 μmol/L; 5.2 Renal function: Creatinine < 220 μmol/L; 5.3 Pulmonary function: Indoor oxygen saturation ≥95%; 5.4 Cardiac function: Left ventricular ejection fraction ≥40%.
  • The peripheral superficial veins have smooth blood circulation and can accept intravenous infusion.
  • ECOG score ≤2;
  • The expected survival period is more than three months.

Who cannot join

  • CLL patients who have undergone Richter transformation;
  • Patients known to have active malignant tumors involving the central nervous system. For patients who have previously suffered from central nervous system diseases and have received effective treatment, if they have completed treatment for at least 3 months before enrollment, have no evidence of symptomatic diseases, and the imaging examination shows abnormal stability, they will be considered for enrollment.
  • There is a history of primary malignant tumor, and it has not been relieved for at least two years. The following situations are not subject to the two-year limit: non-melanoma skin cancer, completely resected stage 1 solid tumors with low recurrence risk, radical treatment of local prostate cancer, biopsion-revealed cervical cancer in situ or smear-revealed squamous intraepithelial lesions, and completely resected breast cancer in situ.
  • Active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus infection;
  • There was an uncontrollable systemic fungal, bacterial or viral infection within 4 weeks before enrollment;
  • Have a history of any of the following cardiovascular diseases within the past 6 months: grade III or IV heart failure as defined by the New York Heart Association, angioplasty or stent implantation, myocardial infarction, unstable angina pectoris, clinically obvious arrhythmia, or other clinically significant heart diseases;
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  • Women who are pregnant (with a positive urine/blood pregnancy test) or breastfeeding;
  • Patients who are allergic to large molecule biological drugs such as antibodies or cytokines;
  • Had systemic hormones or immunosuppressive drugs been used within 4 weeks before enrollment (except for patients with inhaled hormones);
  • Suffer from mental illness;
  • The researcher determined that the patient had other conditions that made him unsuitable for inclusion in the group.

Trial locations and contacts

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

Wei Sang, Ph.D. contact

13645207648

xyfylbl515@xzhmu.edu.cn

China1 site, 1 recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

    Wei Sang, Ph.D., 13645207648, xyfylbl515@xzhmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Efficacy of AntiCD19 CAR-T Combined With BTKi in the Treatment of Newly Diagnosed High-risk CLL Patients, and to Explore Its Efficacy and Safety of Limited-term Treatment in These Patients

At present, there is a lack of relevant research on the first-line treatment of high-risk CLL patients with BTKi combined with CAR-T. Therefore, our center plans to conduct a study on the treatment of newly diagnosed high-risk CLL patients with AntiCD19 CAR-T combined with BTKi, in order to increase the uMRD rate of newly diagnosed high-risk patients, thereby improving the long-term prognosis of high-risk CLL patients and reducing the long-term medication rate of CLL patients, providing more treatment options and hope for newly diagnosed high-risk CLL patients.

Read the detailed description

First, the patient's medical history is investigated to see if the disease meets the requirements of the indications; Then inform them of the treatment process and risks, and sign an informed consent form with them. Subsequently, blood samples were taken to test for HIV and sent to the CAR-T manufacturing department for feasibility assessment of T cell production. In about 1-2 weeks, the CAR-T cell production department will evaluate the value-added capacity and transduction efficiency of the patient's cells in vitro to confirm whether the patient's peripheral blood is suitable for large-scale CAR-T cell production.

After infusion of CAR-T, subjects will undergo efficacy and toxicity assessments for 1 year, with a frequency of assessment every 3 months. The evaluation included the remission rate of minimal residual disease (MRD) in peripheral blood/bone marrow (PB/BM) and the expansion of CAR-T cells in the subjects. After completing this assessment, subjects will enter a two-year telephone follow-up and questionnaire phase to assess long-term health problems after treatment, such as recurrence of malignant tumors, and assess the subject's quality of life

Being tested
AntiCD19 CAR-T combined with BTKi in the treatment of newly diagnosed high-risk CLL/SLL patients
Keywords
CAR-T, CLL, SLL

What participants receive

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

  • AntiCD19 CAR-T combined with BTKi in the treatment of newly diagnosed high-risk CLL/SLL patientsOther

    After chemotherapy, the tumors of the patients in the experimental group were re-graded to determine the basic burden status of the tumors. It should include imaging diagnosis, physical examination, laboratory tests of blood, assessment of bone marrow MRD and evaluation of the toxic and side effects of chemotherapy, etc

Study groups in NCT07120633
Study groupRoleWhat they receive
BTKi combined with CAR-T as first-line treatment for high-risk CLL/SLL patientsExperimentalTo study the efficacy of AntiCD19 CAR-T combined with BTKi in the treatment of newly diagnosed high-risk CLL patients, and to explore the efficacy and safety of limited treatment with this combination in these patients.
Receives: Other: AntiCD19 CAR-T combined with BTKi in the treatment of newly diagnosed high-risk CLL/SLL patients

What is being measured

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

  1. The negative rate of minimal/measurable residual disease (MRD) within one year

    Measured: Toxicity assessment was conducted on the subjects as planned (PB/BM assessment at 3 months, 6 months, 9 months, 12 months after CAR-T infusion

Secondary outcomes (2)

  1. Objective remission response rate

    Measured: Toxicity assessment was conducted on the subjects as planned (PB/BM assessment at 3 months, 6 months, 9 months, 12 months after CAR-T infusion

  2. Progression-free survival time

    Measured: Toxicity assessment was conducted on the subjects as planned (PB/BM assessment at 3 months, 6 months, 9 months, 12 months after CAR-T infusion

Timeline

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

  1. First posted13 Aug 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07120633
Sponsor's protocol ID
XYFY2025-KL304-01
Status last verified
Jul 2025
First submitted
25 Jul 2025
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AntiCD19 CAR-T combined with BTKi in the treatment of newly diagnosed high-risk CLL/SLL patients in people with CLL and CAR-T Cell Therapy, run by The Affiliated Hospital of Xuzhou Medical University at 1 site 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 12 inclusion and 11 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 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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 Wei Sang, Ph.D. (13645207648, xyfylbl515@xzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The negative rate of minimal/measurable residual disease (MRD) within one year (time frame: Toxicity assessment was conducted on the subjects as planned (PB/BM assessment at 3 months, 6 months, 9 months, 12 months after CAR-T infusion). 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 NCT07120633.

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 13 Aug 2025.

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