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Hematologic MalignanciesPhase 1NCT07316907

A Clinical Study of Allogenic CD19-CAR-T in the Treatment of R/R B-Cell Hematologic Malignancies

A Phase 1 study testing 19UCART injection in people with Hematologic Malignancies and Lymphoma, run by YANRU WANG at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-arm, open-label pilot study to evaluate the safety and efficacy of CD19-targeted allogenic CAR-T cells (19UCART) in patients with relapsed/refractory B-cell hematologic malignancies. 12 patients are planned to be enrolled in the dose-escalation trial. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hematologic Malignancies, Lymphoma
What is being tested?
19UCART injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
22 Dec 2025to 31 Dec 2027
Phase
Phase 1
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in this trial with signed informed consent.
  • Diagnosis of B-cell hematologic malignancy according to the 2017 WHO classification, including B-acute lymphoblastic leukemia (B-ALL) and mature B-cell lymphomas such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal-zone lymphoma (MZL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), mantle-cell lymphoma (MCL), etc.
  • Refractory or relapsed B-cell malignancy defined as failure to achieve complete remission after standard therapy, or relapse after achieving remission with first-line or salvage therapy.
  • Persistence of minimal residual disease (MRD) positivity despite hematologic remission in B-cell acute lymphoblastic leukemia (ALL).
  • At least one measurable lesion ≥1.5 cm in longest diameter by IWG revised criteria for relapsed/refractory lymphoma.
  • Age 18-70 years; both sexes eligible.
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  • Expected survival ≥12 weeks.
  • Adequate organ function as follows (no blood products or growth factors within 14 days before first infusion):
  • 1). Hematology: A. White blood cell count (WBC) ≥3.0×10⁹/L B. Absolute neutrophil count (ANC) ≥1.5×10⁹/L C. Platelet count (PLT) ≥100×10⁹/L D. Hemoglobin (Hb) ≥90 g/L 2). Renal: A. Serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min 3). Cardiac: A. Left ventricular ejection fraction (LVEF) ≥50 % B. QTc (Fridericia) ≤450 ms (men) or ≤470 ms (women) 4). Hepatic: A. Total bilirubin ≤1.5×ULN B. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver involvement) 5). Coagulation: A. International normalized ratio (INR) or Prothrombin time (PT) ≤1.5×ULN B. Activated partial thromboplastin time (APTT) ≤1.5×ULN 6). Pulmonary: Diffusing capacity of the lung (DLCO) ≥50 % of predicted (with or without correction for anemia/alveolar volume).
  • 9. ECOG performance status 0-2 at screening. 10. LVEF ≥50 % and no pericardial effusion. 11. At least 2 weeks since last prior therapy (radiation, chemotherapy, monoclonal antibody, or other systemic treatment).
  • 12. Recovery to ≤CTCAE Grade 1 for any preceding serious adverse event (SAE). 13. WOCBP not surgically sterilized must use highly effective contraception from study start through 6 months after last dose; men with WOCBP partners must use highly effective contraception through 3 months after last dose. WOCBP must have negative serum β-hCG within 7 days before first dose and must not be breastfeeding.
  • 14. Ability to comply with study visit schedule and all protocol requirements.
  • WOCBP = women of child-bearing potential

Who cannot join

  • Subjects with any of the following conditions are ineligible for this trial:
  • Known hypersensitivity, allergic reaction, intolerance, or contraindication to 19UCART or any study-drug component (including fludarabine, cyclophosphamide, or tocilizumab), or history of severe anaphylaxis.
  • Post-allo-HSCT relapse with active graft-versus-host disease requiring systemic corticosteroids or other immunosuppressants.
  • Uncontrolled active infection of any etiology.
  • Active hepatitis B, hepatitis C, or tuberculosis.
  • HIV or syphilis infection.
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  • Active autoimmune disease or history of severe autoimmune disorder (as judged by the PI) requiring prolonged immunosuppressive therapy.
  • Congenital or acquired immunodeficiency syndromes.
  • New York Heart Association (NYHA) class III or IV heart failure, unstable angina, myocardial infarction within 6 months, or sustained (>30 s) ventricular arrhythmia.
  • History of epilepsy or other significant central nervous system disorders.
  • Extra-nodal lymphomatous involvement of brain, lung, or gastrointestinal tract.
  • Prior malignancy other than:
  • Curatively resected non-melanoma skin cancer (e.g., basal-cell carcinoma)
  • Curatively treated carcinoma in situ (cervical, bladder, breast, etc.)
  • Systemic high-dose corticosteroids within 2 weeks before study entry.
  • Pregnancy, lactation, or intention to become pregnant within 6 months.
  • Participation in another clinical trial within 1 month.
  • Anticipated need for any other systemic anti-neoplastic therapy during the study.
  • Major surgery within 14 days before first study-drug administration.
  • Any condition that, in the investigator's opinion, could increase patient risk or interfere with study results.

Trial locations and contacts

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

Xiaoming Fei, PhD contact

086-1381512462752

feixiaomingujs@aliyun.com

China1 site

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

    Xiaoming Fei, PhD, 086-1381512462752, feixiaomingujs@aliyun.com

    Xiaoming Fei, PhD

Other trials in China

About this study

Official title: An Exploratory Clinical Study of the Safety and Efficacy of Allogenic CD19-Targeted Chimeric Antigen Receptor T-Cell Injection in the Treatment of Relapsed/Refractory B-Cell Hematologic Malignancies

This is a single-arm, open-label pilot study to evaluate the safety and efficacy of CD19-targeted allogenic CAR-T cells (19UCART) in patients with relapsed/refractory B-cell hematologic malignancies. 12 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The secondary objective is to evaluate the efficacy of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The exploratory objective is to evaluate expansion, persistence and ability of 19UCART to deplete CD19 positive cells in patients with relapsed/refractory B-cell hematologic malignancies.

Being tested
19UCART injection
Keywords
CD19-positive, relapsed/refractory, B-cell hematologic malignancies
Medical subject headings
Hematologic Neoplasms, Lymphoma, Recurrence

What participants receive

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

  • 19UCART injectionBiological

    19UCART injection is a CD19-targeted allogenic CAR-T. A single infusion of CAR-T cells will be administered intravenously.

Study groups in NCT07316907
Study groupRoleWhat they receive
relapsed/refractory B-cell hematologic malignanciesExperimentalrelapsed/refractory B-cell hematologic malignancies patients to be treated with 19UCART cells
Receives: Biological: 19UCART injection

What is being measured

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

  1. Toxicity and adverse-event grading after 19UCART treatment

    all toxicities and AEs will be assessed according to the National Cancer Institute CTCAE v5.0

    Measured: up to 12 months after infusion

  2. CRS grading after 19UCART treatment

    CRS will be graded using the Lee DW et al. CRS grading scale

    Measured: up to 12 months after infusion

Secondary outcomes (4)

  1. Overall response rate (ORR = CR + PR) of patients receive 19UCART treatment

    according to the Lugano criteria and CSCO guidelines

    Measured: 1, 3, 6, and 12 months after infusion

  2. Disease control rate (DCR = CR + PR + SD) of patients receive 19UCART treatment

    according to the Lugano criteria and CSCO guidelines

    Measured: 1, 3, 6, and 12 months after infusion

  3. PET-CT Response Criteria according to Lugano metabolic response categories

    Tumor measurements and evaluations must be performed with the same technique used at baseline. CMR (5-PS 1-3 in all baseline sites); PMR (5-PS 4-5 but uptake ↓ vs base or ΔSUVmax ↓ ≥ 25 %); NMR (5-PS 4-5 with no significant Δ); PMD (5-PS 4-5 and uptake ↑ > 50 % or new lesion). Deauville 5-Point Scale (5-PS): Scores 1-3 = metabolic CR; 4-5 = residual disease.

    Measured: 1, 3, 6, and 12 months after infusion

  4. CAR copies and cell count of CAR-T in blood after 19UCART treatment

    Measured: Day 0, 1, 3, 5, 7, 9, 11, 14, 21, 28, and month 2, 3, 6, 9, 12 after infusion

Timeline

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

  1. First posted5 Jan 2026
  2. Study start22 Dec 2025 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07316907
Sponsor's protocol ID
EU19
Status last verified
Dec 2025
First submitted
9 Dec 2025
Last updated
5 Jan 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 19UCART injection in people with Hematologic Malignancies and Lymphoma, run by YANRU WANG 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 20 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: opening soon, as of the sponsor's last update on 5 Jan 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?

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 Xiaoming Fei, PhD (086-1381512462752, feixiaomingujs@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity and adverse-event grading after 19UCART treatment (time frame: up to 12 months after 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 NCT07316907.

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 5 Jan 2026.

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