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Relapsed/Refractory B-cell MalignanciesEarly Phase 1NCT07240974

Safety and Efficacy of ZZSW-01 in Relapsed/Refractory B-cell Malignancies

A Early Phase 1 study testing ZZSW-01 injection in people with Relapsed/Refractory B-cell Malignancies, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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
Search all trials

Trial summary

This is a single-center, single-arm, open-label, dose-escalation, early-phase 1 study to evaluate the safety, tolerability and preliminary efficacy of ZZSW-01 injection in patients with relapsed/refractory B-cell malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory B-cell Malignancies
What is being tested?
ZZSW-01 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
28 Oct 2025to 15 Sep 2028
Phase
Early 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following inclusion criteria:
  • Age ≥18 years, no restriction on sex.
  • ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2.
  • Expected survival ≥3 months.
  • Histologically or cytologically confirmed CD19-positive relapsed or refractory B-cell malignancies according to the WHO classification of lymphoid neoplasms, including:
  • Relapsed/refractory B-NHL: patients who have failed at least two prior lines of therapy, are intolerant to the toxicity of second-line regimens, or are not eligible for autologous stem cell transplantation, including but not limited to diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL/high-grade B-cell lymphoma with MYC and BCL2 rearrangements, high-grade B-cell lymphoma not otherwise specified, primary mediastinal B-cell lymphoma, mantle cell lymphoma, grade 3b follicular lymphoma, and transformed large B-cell lymphoma from indolent B-NHL.
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  • Relapsed/refractory precursor B-ALL: patients who relapse after achieving CR following second-line therapy, or who fail to achieve CR/CRi after completion of second-line therapy.
  • For relapsed/refractory B-NHL: at least one measurable lesion as assessed by the investigator (e.g., lymph node with long axis >15 mm, or extranodal lesion with long axis >10 mm).
  • For relapsed/refractory precursor B-ALL: baseline bone marrow blasts ≥5%.
  • Adequate organ function as defined below (no administration of blood components or hematopoietic growth factors within 14 days prior to first dosing):
  • Hematology:
  • Relapsed/refractory B-NHL: ANC ≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥70 g/L, absolute CD8+ T-cell count ≥0.3×10^9/L; if bone marrow involvement is present: ANC ≥1.0×10^9/L, platelets ≥50×10^9/L, hemoglobin ≥70 g/L.
  • Relapsed/refractory precursor B-ALL: ANC ≥1.0×10^9/L (G-CSF support permitted), platelets ≥50×10^9/L (no platelet transfusion within 7 days), hemoglobin ≥80 g/L (no RBC transfusion within 7 days); if bone marrow involvement or not in remission: ANC ≥0.5×10^9/L (G-CSF support permitted), platelets ≥30×10^9/L (no platelet transfusion within 7 days), hemoglobin ≥70 g/L (no RBC transfusion within 7 days). Additionally, absolute CD8+ T-cell count ≥0.2×10^9/L and CD19+ B-cell percentage ≤5%.
  • Liver function: TBIL ≤1.5×ULN; ALT and AST ≤2.5×ULN (≤5×ULN if liver metastases are present).
  • Renal function: Serum creatinine ≤1.5×ULN (if >1.5×ULN, creatinine clearance must be ≥50 mL/min).
  • Coagulation: INR ≤1.5×ULN and APTT ≤1.5×ULN; patients on anticoagulation may be included if INR ≤2.5×ULN.
  • Oxygenation: Oxygen saturation >92% on room air.
  • Non-hematologic toxicities from prior therapies (except disease-related) have resolved to ≤grade 1 before enrollment (excluding alopecia and ≤grade 2 neurotoxicity from chemotherapy).
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to ZZSW-01 infusion. All fertile male and female participants must agree to use effective contraception during the study and for at least 6 months after the last dose. (Definition of women of childbearing potential and contraceptive methods are detailed in Appendix 1.)
  • Ability and willingness to provide written informed consent and to comply with study procedures, follow-up assessments, and treatment.

Who cannot join

  • Participants meeting any of the following conditions will be excluded from this study:
  • Patients with CNS involvement of B-cell malignancies confirmed by lumbar puncture and/or MRI with CNS-related symptoms.
  • Patients with isolated extramedullary relapse of B-ALL.
  • Patients with severe hereditary diseases or congenital hematopoietic dysfunction.
  • Patients with Burkitt's lymphoma/leukemia or blast phase chronic myeloid leukemia (p210 BCR-ABL+).
  • Current or past history of central nervous system disorders, including: seizures, ischemic/hemorrhagic cerebrovascular disease, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric illness, or any autoimmune disease involving the CNS.
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  • Receipt of chemotherapy within 2 weeks prior to ZZSW-01 infusion (except intrathecal chemotherapy for prevention of CNS leukemia, which must be stopped ≥1 week prior to infusion).
  • Prior systemic immune checkpoint inhibitor therapy (e.g., anti-PD-1/PD-L1 mAbs) within fewer than 3 half-lives before ZZSW-01 infusion; or other systemic antitumor therapy within fewer than 2 weeks or 5 half-lives (whichever is shorter) before infusion.
  • Use of systemic therapeutic corticosteroids within 72 hours prior to ZZSW-01 infusion (physiologic replacement doses are allowed, e.g., prednisone <10 mg/day or equivalent).
  • Receipt of targeted therapies or antibody drugs (including BiTEs, antibody-drug conjugates) within 2 weeks, or cytotoxic therapy within 1 week prior to ZZSW-01 infusion.
  • Autologous stem cell transplantation (ASCT) within 6 weeks prior to ZZSW-01 infusion.
  • Any prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).
  • Known history of the following diseases:
  • . Systemic vasculitis (e.g., Wegener's granulomatosis, polyarteritis nodosa)
  • Systemic lupus erythematosus (SLE)
  • . Active or uncontrolled autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, autoimmune hemolytic anemia)
  • . Primary or secondary immunodeficiency (e.g., HIV infection or severe infectious diseases)
  • Evidence of any of the following infections:
  • . Chronic or active hepatitis B (HBV) infection (except HBcAb-positive with HBV DNA <500 IU/mL)
  • . Hepatitis C virus (HCV) infection
  • . Human immunodeficiency virus (HIV) infection
  • . Syphilis infection
  • Major surgery within 4 weeks prior to screening, if deemed unsuitable for enrollment by the investigator.
  • Concurrent active malignancy. (Patients with prior malignancies cured ≥2 years may be eligible).
  • Any of the following cardiac conditions:
  • . Left ventricular ejection fraction (LVEF) ≤45% (by echocardiography)
  • . NYHA class III or IV congestive heart failure
  • . Severe arrhythmia requiring treatment, including QTc ≥450 ms in males or ≥470 ms in females (QTcB=QT/RR1/2)
  • . Uncontrolled hypertension (systolic ≥140 mmHg and/or diastolic ≥90 mmHg), pulmonary hypertension, or unstable angina
  • . Myocardial infarction, bypass surgery, or stent placement within 12 months prior to dosing
  • . Clinically significant valvular heart disease
  • . Any other cardiac disease deemed unsuitable by the investigator
  • Lymphoma involving the atrium or ventricle.
  • Clinical emergencies caused by obstruction or compression from lymphoma masses at screening (e.g., bowel obstruction, vascular compression).
  • History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening.
  • Hypersensitivity (allergy to ≥2 drugs or foods), or known hypersensitivity to components of the investigational product (compound electrolyte injection, 5% human serum albumin).
  • Receipt of live vaccines within 6 weeks prior to screening.
  • Uncontrolled active infection at screening (e.g., sepsis, bacteremia, fungemia, viremia).
  • Participation in another interventional clinical trial with investigational drugs within 3 months prior to ZZSW-01 infusion, or intent to participate in another clinical trial or receive non-protocol antitumor therapy during the study.
  • Any other condition that, in the judgment of the investigator, renders the patient unsuitable for participation.

Trial locations and contacts

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

Heng Mei, Ph.D&M.D contact

027-8572600

hmei@hust.edu.cn

China1 site, 1 recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety and Efficacy of ZZSW-01 in the Treatment of Patients With Relapsed/Refractory B-cell Malignancies

This is a single-center, single-arm, open-label, dose-escalation, early-phase 1 study to evaluate the safety, tolerability and preliminary efficacy of ZZSW-01 injection in patients with relapsed/refractory B-cell malignancies.

Read the detailed description

This investigator-initiated clinical study aims to evaluate ZZSW-01 injection, the extracellular vesicle vector that carries CD19 CAR mRNA, in patients with relapsed/refractory B-cell hematologic malignancies. Under this design, eligible subjects will receive multiple injections. The study adopts a dose-escalation design to assess safety, tolerability, and preliminary efficacy.

Being tested
ZZSW-01 injection
Medical subject headings
Recurrence

What participants receive

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

  • ZZSW-01 injectionDrug

    Also called CAR-EVs

    ZZSW-01 is an extracellular vesicle that carries functional CD19 CAR mRNA, which can be administered intravenously to generate CAR-T cells in vivo.

Study groups in NCT07240974
Study groupRoleWhat they receive
ZZSW-01ExperimentalZZSW-01 is an extracellular vesicle that carries functional CD19 CAR mRNA, which can be administered intravenously to generate CAR-T cells in vivo.
Receives: Drug: ZZSW-01 injection

What is being measured

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

  1. Incidence of Adverse Events

    All adverse events (AEs), including severe adverse events (SAEs) and clinically significant laboratory abnormalities, will be recorded and graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.

    Measured: Up to 28 days post-infusion

  2. Incidence of Dose-Limiting Toxicities (DLTs)

    Dose-limiting toxicities (DLTs) will be specifically identified, recorded, and monitored during the designated DLT observation period.

    Measured: Up to 28 days post-infusion

  3. Incidence and Severity of Cytokine Release Syndrome (CRS)

    Cytokine release syndrome (CRS) events will be identified and graded for severity according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.

    Measured: Up to 28 days post-infusion

  4. Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

    Immune effector cell-associated neurotoxicity syndrome (ICANS) will be assessed using the Immune Effector Cell-Associated Encephalopathy (ICE) score and subsequently graded for severity according to the ASTCT consensus grading.

    Measured: Up to 28 days post-infusion

Secondary outcomes (14)

  1. Complete Response (CR) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.

    Tumor response after ZZSW-01 infusion will be assessed according to the Lugano 2014 criteria or the 2017 ELN criteria, including complete response (CR).

    Measured: From ZZSW-01 infusion to the end of the treatment at 96 weeks

  2. Partial Response (PR) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.

    Tumor response after ZZSW-01 infusion will be assessed according to the Lugano 2014 criteria or the 2017 ELN criteria. The Partial Response (PR) rate will be determined.

    Measured: From ZZSW-01 infusion to the end of the treatment at 96 weeks

  3. Stable Disease (SD) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.

    Tumor response after ZZSW-01 infusion will be assessed according to the Lugano 2014 criteria or the 2017 ELN criteria. The Stable Disease (SD) rate will be determined.

    Measured: From ZZSW-01 infusion to the end of the treatment at 96 weeks.

  4. Progressive Disease (PD) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.

    Tumor response after ZZSW-01 infusion will be assessed according to the Lugano 2014 criteria or the 2017 ELN criteria. The Progressive Disease (PD) rate will be determined.

    Measured: From ZZSW-01 infusion to the end of the treatment at 96 weeks.

  5. Objective response rate (ORR) of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.

    Objective response rate (ORR) after ZZSW-01 infusion will be evaluated according to the Lugano 2014 criteria or the 2017 ELN criteria.

    Measured: From ZZSW-01 infusion to the end of the treatment at 96 weeks

  6. Overall survival (OS) of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.

    Overall survival (OS) after ZZSW-01 infusion will be evaluated according to the Lugano 2014 criteria or the 2017 ELN criteria.

    Measured: From ZZSW-01 infusion to the end of the treatment at 96 weeks

  7. Progression-free survival (PFS) of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.

    Progression-free survival (PFS) after ZZSW-01 infusion will be evaluated according to the Lugano 2014 criteria or the 2017 ELN criteria.

    Measured: From ZZSW-01 infusion to the end of the treatment at 96 weeks

  8. Time to response (TTR) of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.

    Time to response (TTR) after ZZSW-01 infusion will be evaluated according to the Lugano 2014 criteria or the 2017 ELN criteria.

    Measured: From ZZSW-01 infusion to the end of the treatment at 96 weeks

  9. Duration of response (DOR) of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.

    Duration of response (DOR) after ZZSW-01 infusion will be evaluated according to the Lugano 2014 criteria or the 2017 ELN criteria.

    Measured: From ZZSW-01 infusion to the end of the treatment at 96 weeks

  10. Peak Level (Cmax) of CAR-T Cells

    PK parameters: The peak level (Cmax) of CAR-T cells in the peripheral blood will be measured and reported.

    Measured: Baseline, DAY1, Day 4, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 24, Week 36, Week48 or withdrawal from the study, whichever came first.

  11. Pharmacodynamic (PD) characteristics of ZZSW-01 in patients with relapsed/refractory B cell malignancies

    PD parameters: including lymphocyte subgroups, CD19 positive B cell and other cell proportions, various cytokines, immunoglobulins, etc.

    Measured: Baseline, DAY1, Day 4, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 24, Week 36, Week48 or withdrawal from the study, whichever came first.

  12. Time to Peak Level (Tmax) of CAR-T Cells

    PK parameters: The time to reach the peak level (Tmax) of CAR-T cells in the peripheral blood will be determined.

    Measured: Baseline, DAY1, Day 4, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 24, Week 36, Week48 or withdrawal from the study, whichever came first.

  13. Area Under the Curve (AUC0-28d) of CAR-T Cells

    PK parameters: The area under the concentration-time curve from time zero to 28 days (AUC0-28d) for CAR-T cells in the peripheral blood will be calculated.

    Measured: Baseline, DAY1, Day 4, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 24, Week 36, Week48 or withdrawal from the study, whichever came first.

  14. Duration of Persistence of CAR-T Cells

    PK parameters: The duration for which CAR-T cells persist in the peripheral blood will be monitored.

    Measured: Baseline, DAY1, Day 4, Day 7, Day 14, Day 21, Day 28, Week 8, Week 12, Week 24, Week 36, Week48 or withdrawal from the study, whichever came first.

Timeline

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

  1. First posted21 Nov 2025
  2. Study start28 Oct 2025
  3. Primary completion15 Sep 2028 (estimated)
  4. Study completion15 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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07240974
Sponsor's protocol ID
EVB20250627
Status last verified
Nov 2025
First submitted
3 Sep 2025
Last updated
21 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing ZZSW-01 injection in people with Relapsed/Refractory B-cell Malignancies, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 20 inclusion and 40 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 21 Nov 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Heng Mei, Ph.D&M.D (027-8572600, hmei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: Up to 28 days post-infusion). The study lists 4 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 NCT07240974.

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 21 Nov 2025.

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