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AzTrials

Acute Lymphocytic LeukemiaPhase 1NCT05410041

Anti-CD19 CAR-Engineered NK Cells in the Treatment of Relapsed/Refractory B-cell Malignancies

A Phase 1 study testing CAR-NK-CD19 Cells in people with Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia, run by Beijing Boren Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is a single arm, open and multi center exploratory clinical study to observe the safety and effectiveness of CAR NK-CD19 in participants with recurrent or refractory CD19 positive B-cell malignant tumors, and preliminarily evaluate the expansion of this product in vivo and the objective remission rate after… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CAR-NK-CD19 Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
10 May 2022to 3 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Age ≥ 18 years old, regardless of gender;
  • Eastern Cooperative Oncology Group score 0-2;
  • Participants with CD19 positive B-cell malignancies, including acute lymphocytic leukemia (all), chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL);
  • Failure or recurrence of at least 2-line treatment (including immunotherapy, targeted therapy and stem cell transplantation);
  • Measurable lesions with an expected survival of more than 3 months;
  • The functions of liver, kidney, heart and lung meet the following requirements:
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  • creatinine clearance rate ≥ 60ml / min ;
  • ALT (alanine transaminase, ALT) / AST (aspartate aminotransferase, AST) ≤ 2.5 times the upper normal limit;
  • total bilirubin ≤ 1.5 times the upper limit of normal value, except for participants with Gilbert syndrome, the total bilirubin must be < / = 3.0 mg / dl;
  • left ventricular ejection fraction ≥ 50%, no clinically significant ECG results;
  • blood oxygen saturation > 92% in non oxygen absorption state;
  • The subjects agreed to use reliable contraceptive methods for contraception within 1 year from the signing of informed consent to reinfusion. Including but not limited to: abstinence, male vasectomy, implantable progesterone contraceptives that can inhibit ovulation; Intrauterine device; Hormone releasing intrauterine device; Sexual partner sterilization; Copper IUD, correct use of proven compound hormone contraceptives that can inhibit ovulation; Progesterone contraceptives that inhibit ovulation. At the same time, the subjects should promise not to donate eggs (oocytes, oocytes) / sperm for assisted reproduction within 1 year after reinfusion;
  • Voluntarily participate in clinical trials and sign informed consent.

Who cannot join

  • Known allergic reaction, hypersensitivity, intolerance or contraindication to CAR NK-CD19 or any component of drugs that may be used in the study (including fludarabine, cyclophosphamide and tozumab), or subjects who have had severe allergic reaction in the past;
  • Participants with gastrointestinal lymph nodes and / or central nervous system involvement who were judged by the researchers to be at risk by CAR NK-CD19 treatment (except those who were judged by the researchers to be more likely to benefit than risk);
  • Those who have graft-versus-host response and need to use immunosuppressants; or suffering from autoimmune diseases;
  • Before screening, the researchers judged that corticosteroids needed to receive a long-term therapeutic dose during the study period;
  • Received the following anti-tumor treatment within the specified time before screening:
  • Have received small molecule targeted therapy within 4 weeks or 5 half lives (whichever is longer); ii. Have received macromolecular drug treatment within 4 weeks or 2 half lives (whichever is longer); iii. Have received cytotoxic treatment or modern traditional Chinese medicine preparation with antitumor effect within 2 weeks;
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  • Those who have been vaccinated with live vaccine or attenuated vaccine within 4 weeks before screening; Note: it is allowed to receive inactivated virus vaccine for seasonal influenza; However, it is not allowed to receive live attenuated influenza vaccine for intranasal use;
  • History of epilepsy or other central nervous system diseases;
  • Other active malignant tumors in the two years before screening (except for the following cases: tumors targeted in this study, surgically removed non-melanoma skin cancer, cured cervical carcinoma in situ, local prostate cancer, low-stage bladder cancer, breast ductal carcinoma in situ, or no recurrence and no treatment of malignant tumors in the two years before randomization);
  • Within 14 days before enrollment, there were active or uncontrollable infections requiring systemic treatment;
  • Active hepatitis B participants; Hepatitis C virus (HCV) antibody positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis antibody positive in primary screening;
  • Participants with inactive / asymptomatic carrier, chronic or active HBV infection can be included if they meet the following conditions: HBV DNA < 500 IU / ml (or 2500 copies / ml) at the time of screening.
  • The toxicity (including peripheral neuropathy) caused by previous treatment has not fully recovered or stabilized to grade 1 (nci-ctcae V5.0) (except those that the researcher judges will not affect the patient's safe treatment, such as hair loss);
  • Heart disease: there is heart failure (NYHA classification ≥ class II, Appendix 2) and serious heart disease determined by the researcher; Myocardial infarction occurred ≤ 6 months before screening; Unstable angina pectoris, severe arrhythmia judged by the researcher or coronary artery bypass grafting (CABG) occurred ≤ 3 months before screening;
  • Poor control of hypertension (systolic blood pressure > 160 mmHg and / or diastolic blood pressure > 100 mmHg) or accompanied by hypertensive crisis or hypertensive encephalopathy;
  • Participants who had undergone major surgery or plasma separation other than diagnosis or biopsy within 4 weeks before screening, or were expected to undergo major surgery during the study; Note: participants who plan to perform surgery under local anesthesia can participate in the study. Kyphoplasty or laminoplasty is not considered a major operation;
  • Those who are receiving thrombolytic, anticoagulant or antiplatelet therapy;
  • The subjects judged by the researcher are difficult to complete all visits or operations required by the study protocol, or the compliance of participating in the study is insufficient.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Boren Hospital

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: Safety and Efficacy of Anti-CD19 CAR-Engineered NK Cells for Relapsed/Refractory B-cell Malignancies: a Multi-center, Open-label, Single-arm Clinical Study

This study is a single arm, open and multi center exploratory clinical study to observe the safety and effectiveness of CAR NK-CD19 in participants with recurrent or refractory CD19 positive B-cell malignant tumors, and preliminarily evaluate the expansion of this product in vivo and the objective remission rate after administration.

Read the detailed description

The study will enroll 9-21 participants diagnosed with recurrent or refractory CD19 positive B-cell malignant tumors, including acute B-lymphocyte leukemia, B-cell non-Hodgkin's lymphoma and chronic B-lymphocyte leukemia. There will be three preset dose groups in this clinical trial, which are 1.0×10^7、2.0×10^7 and 3.0×10^7 CAR positive NK cells / kg (body weight), SRC will discuss and decide the next infusion plan. Participants will be enrolled from low dose group to high dose group, each dose will enroll at least 3 cases. Dose escalation will be decided by the SRC (Safety Review Committee) separately by diseases. There will be expanded cases in the aim dose group, which will at most to 6 cases. The protocol will be performed into screening period (-30~-10 days), prophase of lymophodepletion (-10~-5 days), Lymophodepletion (-5~-3 days), pre-infusion evaluation (-2~-1 days), infusion (day 0), and follow-up period (1-720 days). According to the administration strategy, we will start from single administration. Only after the SRC's decision based on safety and PK data, we could explore further on multiple administrations or combo therapy strategy.

Being tested
CAR-NK-CD19 Cells
Keywords
CAR-NK, CD19 positive, B-cell malignancy
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

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

  • CAR-NK-CD19 CellsBiological

    CAR-NK-CD19 Cells, 1-3×10^7 /KG, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 25-30 mg/kg (D-5~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 250-300 mg/kg (D-5~D-3), determined by tumor burden at baseline.

Study groups in NCT05410041
Study groupRoleWhat they receive
CAR-NK-CD19 CellsExperimentalAfter preconditioning with chemotherapy, CAR-NK-CD19 Cells will be evaluated.
Receives: Biological: CAR-NK-CD19 Cells

What is being measured

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

  1. Safety of CAR NK-CD19 Cell

    Safety of CAR NK-CD19 will be assessed by incidence and severity of AEs and SAEs.

    Measured: Up to 3 months after cell infusion

  2. The overall response rate (ORR)

    Objective response rate (ORR) according to NCCN, Complete response(CR),CR with incomplete blood count recovery(CRi).

    Measured: Up to 3 months after cell infusion

Secondary outcomes (2)

  1. Concentration of PK CAR positive NK cells in peripheral blood

    PK CAR positive NK cells in peripheral blood, PK CAR transgene levels in peripheral blood

    Measured: Up to 3 months after cell infusion

  2. Pharmacodynamic data in peripheral blood

    The amount and duration of antibody to CAR NK-CD19 cells in peripheral blood.

    Measured: Up to 3 months after cell infusion

Timeline

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

  1. First posted8 Jun 2022
  2. Study start10 May 2022
  3. Primary completion3 Jul 2025
  4. Study completion3 Jul 2025

Why it stopped: No participants.

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05410041
Sponsor's protocol ID
BRYY-IIT-LCYJ-2022-003
Status last verified
Oct 2026
First submitted
26 May 2022
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAR-NK-CD19 Cells in people with Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia, run by Beijing Boren Hospital 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 13 inclusion and 18 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: withdrawn, as of the sponsor's last update on 15 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 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.

What does this 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.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of CAR NK-CD19 Cell (time frame: Up to 3 months after cell infusion). The study lists 2 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 NCT05410041.

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 15 Oct 2026.

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