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Recurrent/Refractory B-cell LymphomaPhase 1NCT07367685

Clinical Study of Universal CD19 CAR-γδT Cell Injection in the Treatment of Adult Relapsed/Refractory B-cell Lymphoma

A Phase 1 study testing QH103 Cell Injection, Cyclophosphamide and Fludarabine in people with Recurrent/Refractory B-cell Lymphoma, run by The Second Affiliated Hospital of Fujian Medical University 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 study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell injection solution in adult subjects with relapsed/refractory CD19-positive B-cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent/Refractory B-cell Lymphoma
What is being tested?
QH103 Cell Injection, Cyclophosphamide and Fludarabine
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
1 May 2026to 31 Dec 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years, no gender restrictions;
  • Clinically diagnosed with relapsed/refractory B-cell lymphoma, malignant B- cell lymphoma (according to the Lugano (2014) criteria, with at least one evaluable tumour lesion, defined as: Lymph node lesions with a longest diameter exceeding 1.5 cm, or extranodal lesions with a longest diameter exceeding 1.0 cm), including diffuse large B-cell lymphoma (DLBCL-NOS), encompassing activated B-cell (ABC)/grossly centre B-cell (GCB) subtypes, primary mediastinal (thymic) large B-cell lymphoma (PMBCL), transformative follicular lymphoma (TFL), high-grade B-cell lymphoma (HGBCL) with MYC and BCL2 and/or BCL6 rearrangements,follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL)
  • Relapsed B-cell lymphoma is defined as disease progression following ≥2 systemic therapies;
  • Refractory disease is defined as failure to achieve complete remission (CR) on first-line therapy, or best response to first-line therapy being disease progression (PD), or best response after at least 4 cycles of first-line therapy being stable disease (SD)(e.g., 4 cycles of R-CHOP), or best response after at least 6 cycles being partial remission (PR) with biopsy-confirmed residual disease or disease progression within ≤6 months of treatment.
  • Cytologically or histologically confirmed CD19-positive tumour cell immunophenotyping;
  • Expected survival exceeding 3 months;
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • Major organ function meeting the following criteria: Echocardiogram showing left ventricular ejection fraction ≥50%; serum creatinine ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 × ULN; total bilirubin ≤ 1.5 × ULN;
  • Negative pregnancy test for women of childbearing potential; both male and female subjects must agree to use effective contraception during treatment and for 1 year thereafter;
  • Toxicity from prior antineoplastic therapy ≤ Grade 1 (per CTCAE version 5.0) or acceptable to the inclusion/exclusion criteria;
  • No significant hereditary disorders;
  • Ability to comprehend trial requirements and procedures, with willingness to participate in the clinical study as directed;
  • Signing of the trial informed consent form.

Who cannot join

  • Presence of central nervous system (CNS) involvement or clinically significant history of CNS disorders, such as epilepsy and cerebrovascular disease;
  • Pregnant or lactating women, or women unwilling to use effective contraception during treatment and for 1 year post-treatment;
  • Unremitted other malignancies;
  • Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;
  • Patients who received allogeneic immune cell therapy within 6 months prior to enrolment, or donor lymphocyte infusion within 6 weeks prior to enrolment;
  • Confirmed serum reactivity positive for anti-FMC63 and DSA;
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  • Patients participating in other clinical trials within 4 weeks prior to enrolment;
  • Uncontrolled infectious diseases or other serious conditions, including but not limited to infections (Human Immunodeficiency Virus, acute or chronic active hepatitis B or C), congestive heart failure, unstable angina pectoris, arrhythmias, or conditions deemed to pose unpredictable risks by the treating physician;
  • History of stroke or intracranial haemorrhage within 3 months prior to enrolment;
  • Major surgery or trauma within 28 days prior to enrolment, or unresolved significant adverse events;
  • History of allergy to any component of the cell product;
  • Inability to comprehend or unwillingness to sign the informed consent form;
  • Other reasons deemed by the investigator to render the patient unsuitable for the clinical trial.

Trial locations and contacts

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

Jianda Hu contact

+86 13959169016

drjianda_hu@163.com

China1 site

  • The Second Affiliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

    Jianda Hu, +86 13959169016, drjianda_hu@163.com

    Meiling Li, +86 15880909409, 2189356143@qq.com

Other trials in China

About this study

This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell injection solution in adult subjects with relapsed/refractory CD19-positive B-cell lymphoma.

Being tested
QH103 Cell Injection, Cyclophosphamide, Fludarabine
Keywords
CD19, CAR-γδT, cell therapy
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • QH103 Cell InjectionBiological

    Also called CD19CAR-γδT cell injection

    Biological: CD 19-CAR T cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (3×10^8 CAR+cells) ,dose 2 (6× 10^8 CAR+cells).

  • CyclophosphamideDrug

    Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (500-1000 mg/m² administered 3 days).

  • FludarabineDrug

    Eligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-40 mg/m² administered 3 days).

Study groups in NCT07367685
Study groupRoleWhat they receive
Adult patients with relapsed/refractory CD19-positive B-cell lymphomaExperimentalA conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH103 Cells Interventions: Biological: QH103 Cell Injection Drug: Fludarabine Drug: Cyclophosphamide
Receives: Biological: QH103 Cell Injection; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

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

  1. Adverse Event

    AE is defined as any adverse medical event from the date of leukapheresis to 12 months after QH103 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0

    Measured: 12months

  2. Incidence of Dose-Limiting Toxicities (DLTs)

    DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion.

    Measured: First infusion date of QH103 cells to 28 days end cell infusion

  3. Maximum tolerated dose (MTD)

    MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.

    Measured: 28 days

Secondary outcomes (9)

  1. PK-Tmax

    Time to peak in CAR-T cell count in peripheral blood after infusion of QH103.

    Measured: 12 months

  2. Pharmacodynamics: Peak level of cytokines in serum

    The Changes from baseline of level cytokines and chemokines in peripheral blood after infusion of QH103

    Measured: 12 months

  3. Overall Response Rate(ORR)

    Defined as complete response plus partial response.

    Measured: 6 months

  4. Overall Survival（OS）

    Survival as estimated by Kaplan-Meier method. Death from any cause is considered as event for analysis.

    Measured: 6 months&12 months

  5. Progression-Free Survival（PFS）

    Survival as estimated by Kaplan-Meier method. The length of time during and after the treatment of a disease is considered as event for analysis.

    Measured: 6 months

  6. PK-Cmax

    Peak concentration (Cmax) in the CAR-T cell count in peripheral blood after infusion of QH103.

    Measured: 12 months

  7. PK-AUC

    Area under the concentration-time curve of CAR-T cell count in peripheral blood after infusion of QH103 from 0 to 12 months

    Measured: 12 months

  8. PK-Tlast

    The final time point in CAR-T cell count in peripheral blood after infusion of QH103.

    Measured: 12 months

  9. PK-Clast

    The final point concentration (C last) in the CAR-T cell count in peripheral blood after infusion of QH103

    Measured: 12 months

Timeline

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

  1. First posted26 Jan 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion31 Dec 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 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
NCT07367685
Sponsor's protocol ID
QH10309-NHB-01（0）
Status last verified
Jan 2026
First submitted
5 Jan 2026
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: If used for publication in academic papers, data that does not involve the personal privacy of research subjects will be provided in accordance with journal requirements.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing QH103 Cell Injection, Cyclophosphamide and Fludarabine in people with Recurrent/Refractory B-cell Lymphoma, run by The Second Affiliated Hospital of Fujian 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 13 inclusion and 13 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 26 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 Jianda Hu (+86 13959169016, drjianda_hu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event (time frame: 12months). The study lists 3 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 NCT07367685.

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 26 Jan 2026.

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