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Non-hodgkin Lymphoma,B CellPhase 1/2NCT06838832

Novel Allogenic CD19-targeting CAR-γδT Cell Therapy (QH103E) in r/r NHL

A Phase 1/2 study testing Allogenic CD19-CAR-γδT cell, Fludarabine and Cyclophosphamide in people with Non-hodgkin Lymphoma,B Cell, run by Chinese PLA General Hospital 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

CD19-CAR-γδT cell therapy is a cellular immunotherapy targeting CD19 to perform CAR modification on allogeneic γδT cells. A novel version of the CAR-γδT product by gene editing (QH103E) that has been validated for resistance to alloreactive T cell killing and enhancement of memory efficacy will be used in this study. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-hodgkin Lymphoma,B Cell
What is being tested?
Allogenic CD19-CAR-γδT cell, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
27 Jul 2025to 1 Mar 2028
Phase
Phase 1/2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 (inclusive).
  • Patients with histologically confirmed CD19-positive B-cell NHL.
  • Relapse after treatment with ≥2 lines systemic therapy for all the B-cell NHL disease types, or refractory disease for aggressive types (DLBCL-NOS, PMBCL, TFL and HGBCL). Relapse disease is defined as disease progression after last regimen. Refractory disease is defined as no CR to first-line therapy:
  • PD as best response to first-line therapy, or
  • SD as best response after at least 4 cycles of first-line therapy (eg,4 cycles of R-CHOP), or
  • PR as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 6 months of therapy. or refractory post-autologous stem cell transplant (ASCT): i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed individuals); ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy.
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  • The estimated survival time is over 3 months.
  • The Eastern Cooperative Oncology Group (ECOG) score is 0-2.
  • According to Lugano response criteria 2014, there should be at least one evaluable tumor focus. Evaluable tumor focus was defined as that with the longest diameter of intranodal focus > 1.5cm, the longest diameter of extranodal focus > 1.0cm assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
  • Subjects must be willing to undergo either excised or large-needle lymph node or tissue biopsy, or provide formalin-fixed paraffin-embedded (FFPE) tumor tissue block or freshly cut unstained slides.
  • Functions of important organs meet the following requirements:
  • Echocardiography showed left ventricular ejection fraction ≥50%. Serum creatinine ≤1.5 × upper limit of normal range (ULN) or endogenous creatinine clearance ≥45mL/min (cockcroft-gault formula); Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤3 times ULN, Total bilirubin ≤1.5× ULN; Pulmonary function: ≤CTCAE grade1 dyspnea and oxygen saturation of blood (SaO2) ≥91% in indoor air environment.
  • Blood routine (normal values shall not be obtained with growth factors, and hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions below): hemoglobin (Hgb) ≥80g/L, neutrophil count≥1×10^9/L, platelet (PLT) ≥75×10^9/L.
  • Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.
  • Toxicity from previous antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or to an acceptable level of inclusion/exclusion criteria (other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject).
  • No obvious hereditary diseases.
  • Able to understand the requirements and matters of the trial, and willing to participate in clinical research as required.
  • Informed consent must be signed.

Who cannot join

  • During the screening period, there was central nervous system (CNS) invasion or a history of clinically significant central nervous system diseases, such as epilepsy and cerebrovascular diseases.
  • Women who are pregnant or breastfeeding, or who do not agree to use effective contraception during treatment and during the subsequent 1 year.
  • History of allogeneic hematopoietic stem cell transplantation, or organ transplantation.
  • History of other malignancies that have not been in remission.
  • Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy.
  • Received radiotherapy within 3 months before enrollment.
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  • Received immunotherapy drugs within 4 weeks before enrollment, such as anti-programmed death 1 (PD-1) antibody, anti-programmed death ligand 1 (PD-L1) antibody, CD19/CD3-bispecific antibody, and so on.
  • Patients who received any immunocellular therapy within 6 months before enrollment.
  • Confirmed evidence showing positiveness of anti-CD19 scFv reaction in patient serum.
  • Patients who participated in other clinical trials within 4 weeks prior to enrollment.
  • Uncontrolled infectious diseases or other serious illnesses, including but not limited to infections [e.g., human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B (HBV) or C (HCV) infection], congestive heart failure, unstable angina, arrhythmias, or that pose an unpredictable risk in the opinion of the attending physician.
  • The presence of uncontrollable serous membrane fluid, such as massive pleural effusion or ascites.
  • A history of stroke or intracranial hemorrhage within 3 months prior to enrollment.
  • Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.
  • Received allogeneic cell therapy within 6 weeks prior to enrollment, such as donor lymphocyte infusion.
  • History of allergies to any of the ingredients in cell products.
  • Conditions in which a known mental or physical illness interferes with cooperation with the requirements of the study or disrupts the results or interpretation of the results and, in the opinion of the therapeutic investigator, makes the patient unfit for study participation.
  • There is the situation that the researcher's judgment will interfere with the whole study participation; Situations where there is significant risk to the subject; Or interferes with the interpretation of research data.
  • Inability to understand or unwillingness to sign informed consent.
  • Researchers believe that other reasons are not suitable for clinical trials.

Trial locations and contacts

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

Weidong Han contact

+86-010-55499341

hanwdrsw@sina.com

China1 site, 1 recruiting

  • Biotherapeutic Department of Chinsese PLA Gereral Hospital

    Beijing, Beijing Municipality, 100853·

    Weidong Han, PH.D, 010-66937463 ext. +86, hanwdrsw69@yahoo.com

    Yang Liu, M.D, 010-66939460 ext. +86, liuyang301blood@163.com

    Recruiting

Other trials in China

About this study

Official title: Novel Allogenic CD19-targeting Chimeric Antigen Receptor γδT Cells Therapy (QH103E) in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

CD19-CAR-γδT cell therapy is a cellular immunotherapy targeting CD19 to perform CAR modification on allogeneic γδT cells. A novel version of the CAR-γδT product by gene editing (QH103E) that has been validated for resistance to alloreactive T cell killing and enhancement of memory efficacy will be used in this study.

This is a single center, prospective, open-label, single-arm, phase 1/2 study. A total of around 30 patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) will be enrolled in the study and receive QH103E product infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of QH103E in patients with r/r B-cell NHL.

Read the detailed description

Phase 1 (dose escalation) In phase 1, 9-12 subjects will be enrolled. Subjects will receive 3 doses of QH103E therapy (1× 10^6 cells/kg; 3× 10^6 cells/kg; 6 × 10^6 cells/kg) increases from low dose to high dose according to the "3 + 3" principle:

  1. Three patients were enrolled in the lowest dose group.
  2. Subsequent patients were enrolled according to the following rules:
  3. If the incidence of dose limiting toxicity (DLT) was 0/3, 3 patients were enrolled in the next high-dose group.
  4. If the incidence of DLT was 1/3, 3 patients were enrolled at the same dose; If the incidence of DLT was 1/3 + 0/3, 3 patients were enrolled in the next high-dose group. If the incidence of DLT was 1/3 + 1/3, this dose was defined as maximum tolerated dose (MTD); If the incidence of DLT was 1/3 + 2/3 or 1/3 + 3/3, the previous dose was MTD.
  5. If the incidence of DLT was 2/3 or 3/3, the previous dose was MTD. To ensure the safety of the subjects, the first subject in each dose group was observed for at least 28 days after the cell infusion. If no DLT occurred, the remaining two subjects could be enrolled and treated at the same dose level. The safety data of all subjects in each dose group until day 28 should be reviewed and tolerated before proceeding to the next dose group trial. No dose escalation was allowed for the same subject during the trial. If a subject drop out during the observation period due to non-DLT reasons, new subjects should be enrolled to make up for the number of subjects who drop out. Phase 2 (expansion cohort) In phase 2, 15 to 20 subjects will be enrolled and receive QH103E infusion at dose of RP2D, which will be determined based on the MTD, occurrence of DLT, the obtained efficacy results, pharmacokinetics/ pharmacodynamics and other data according to the phase 1.
Being tested
Allogenic CD19-CAR-γδT cell, Fludarabine, Cyclophosphamide
Keywords
B-cell malignancies, Relapsed or refractory, allogeneic CD19-CAR-γδT, gene editing
Medical subject headings
Recurrence

What participants receive

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

  • Allogenic CD19-CAR-γδT cellBiological

    Phase 1 dose escalation (3+3) : dose 1 (1 × 10^6 cells/kg) , dose 2 (3 × 10^6 cells/kg), dose 3 (6× 10^6 cells/kg); Phase 2 : dose of RP2D.

  • FludarabineDrug

    Also called Fludarabine Phosphate for Injection

    Intravenous fludarabine 30~50 mg/m^2/day on days

    -5, -4, and -3.

  • CyclophosphamideDrug

    Also called Cyclophosphamide for Injection

    Intravenous cyclophosphamide 500~1000 mg/m^2/ day on days -5, -4, and -3.

Study groups in NCT06838832
Study groupRoleWhat they receive
Patients with refractory or relapsed B-cell NHLExperimentalA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, QH103E product.
Receives: Biological: Allogenic CD19-CAR-γδT cell; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

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

  1. Phase 1: Incidence of Adverse Events (AEs)

    AE is defined as any adverse medical event from the date of lymphodepletion to 12 months after QH103E 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-versus-host 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: 12 months

  2. Phase 1: Incidence of Dose-Limiting Toxicities (DLTs)

    DLT was defined as QH103E-related events with onset within first 28 days following infusion:

    • Grade 3 aGVHD that does not resolve to Grade 1 or 2 within 7 days, with the exception of isolated skin involvement aGVHD;
    • Grade 4 CRS, or grade 3 CRS that does not resolve to grade 2 or lower within 2 weeks;
    • Grade 3 ICANS lasting for ≥7 days or Grade 4 ICANS;
    • Any other Grade ≥4 and Grade 3 AE related to the QH103E that lasts for ≥14 days, except hematology toxicity.

    Measured: 28 days

  3. Phase 1: Recommended phase 2 dose (RP2D)

    The recommended dose for phase 2 was determined through phase 1 study

    Measured: 12 months

  4. Phase 2: Best objective Response Rate

    The incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as the best response to treatment assessed by investigators and based on the Lugano 2014 assessment criterion.

    Measured: 12 months

Secondary outcomes (5)

  1. Phase 2: Overall Survival (OS)

    OS is defined as the time from QH103E infusion to the date of death. Subjects who have not died by the analysis data cutoff date will be censored at their last contact date.

    Measured: 12 months after the first infusion of QH103E infusion

  2. Phase 2: Progression Free Survival (PFS)

    PFS is defined as the time from the QH103E infusion date to the date of disease progression assessed by investigators and based on the Lugano 2014 assessment criterion, or death any cause. Participants not meeting thecriteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.

    Measured: 12 months after the first infusion of QH103E infusion

  3. Phase 2: Duration of Response (DOR)

    DOR is defined as the date of their first CR or PR (which is subsequently confirmed) to PD assessed by investigators and based on the Lugano 2014 assessment criterion for r/r B-cell NHL, or death regardless of cause.

    Measured: 12 months after the first infusion of QH103E infusion

  4. Pharmacokinetics: Number and copy number of QH103E (phase 1 and phase 2)

    Number and copy number of QH103E were assessed by number in peripheral blood. Blood samples were collected before and one year after cell infusion (QH103E were not detected for two consecutivetimes) to detect the number and copy number of QH103E, and to evaluate the pharmacokinetics of QH103E.

    Measured: 12 months

  5. Pharmacodynamics: Peak level of cytokines in serum (phase 1 and phase 2)

    The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, tumor necrosis factor

    Measured: Up to 28 days 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 posted21 Feb 2025
  2. Study start27 Jul 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06838832
Sponsor's protocol ID
CHN-PLAGH-BT-091
Status last verified
Jul 2025
First submitted
17 Feb 2025
Last updated
30 Jul 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 Phase 1/2 study testing Allogenic CD19-CAR-γδT cell, Fludarabine and Cyclophosphamide in people with Non-hodgkin Lymphoma,B Cell, run by Chinese PLA General 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 18 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: looking for participants now, as of the sponsor's last update on 30 Jul 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Weidong Han (+86-010-55499341, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Incidence of Adverse Events (AEs) (time frame: 12 months). 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 NCT06838832.

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 30 Jul 2025.

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