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Relapsed or Refractory B-cell Non-Hodgkin LymphomaNCT05797948

GZL Sequential CD19/CD22 CAR-T in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

A study testing Obinutuzumab, Zanubrutinib and Lenalidomide in people with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study intends to use Obinutuzumab, Zanubrutinib, and Lenalidomide sequential CD19/CD22 CAR-T in the treatment of Relapsed or Refractory B-cell Non-Hodgkin Lymphoma patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Obinutuzumab, Zanubrutinib and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Jul 2022to 30 Jun 2024
Phase
Interventional
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

  • Histologically confirmed CD22 + and/or CD19 + aggressive B-cell non-Hodgkin lymphoma (NHL), including the following types as defined by World Health Organization (WHO) 2016:
  • Diffuse large B-cell lymphoma (DLBCL); High grade B-cell lymphoma (HGBL); Primary mediastinal large B-cell lymphoma(PMBCL); T cell/histiocyte-rich large B-cell lymphoma (THRBCL); High grade follicular cell lymphoma Grade 3b (3bFL); Mantle cell lymphoma (MCL) except indolent; Other aggressive B-cell lymphomas.
  • Disease refractory to first-line therapy or early relapse within 12 months of last treatment.
  • Relapse or progressive disease (PD) ≥ 3 months after targeted CD19 therapy including CD19 CAR T cells or anti-CD19/anti-CD3.
  • Successful leukapheresis assessment and T-cell preculture.
  • Life expectancy > 3 months.
Show all 12Show fewer
  • Appropriate organ function:
  • Creatinine < 1.6 mg/dL (140 µmol/L) or creatinine clearance ≥ 60ml/min; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 3 × upper limit of normal; Bilirubin < 2.0 mg/dL unless subject has Gilbert 's syndrome (< 3.0 mg/dL); Pulmonary reserve ≤ Grade 1 dyspnea and SPO2 > 91%; Cardiac ejection fraction ≥ 50% in the absence of oxygen, no evidence of pericardial effusion as determined by echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings.
  • Adequate bone marrow reserve was defined as:
  • Absolute neutrophil count (ANC) > 1000/mm3; Absolute lymphocyte count (ALC) ≥ 300/mm3; Platelet count ≥ 50,000/mm3. Hemoglobin > 7.0 mg/dL.
  • Measurable or evaluable lesions according to "IWG response criteria for malignant lymphoma" (Cheson 2014).
  • Patients have the ability to understand and are willing to provide written informed consent.

Who cannot join

  • severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal);
  • the presence of structural heart disease, and lead to clinical symptoms or abnormal heart function (NYHA ≥ 2);
  • uncontrolled active infection;
  • the presence of other tumors requiring treatment or intervention;
  • the current or expected need for systemic corticosteroid therapy;
  • pregnant or lactating women.
  • Other psychological conditions that prevent patients from participating in the study or signing informed consent;
  • According to the investigator 's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or fail to meet the requirements for participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: Prospective, Single-center, Single-arm, Open-label Study of Obinutuzumab, Zanubrutinib and Lenalidomide Sequential CD19/CD22 CAR-T in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

This study intends to use Obinutuzumab, Zanubrutinib, and Lenalidomide sequential CD19/CD22 CAR-T in the treatment of Relapsed or Refractory B-cell Non-Hodgkin Lymphoma patients. The main purpose of this study is to explore a new treatment mode for R/R B-NHL patients and observe the efficacy and safety of this treatment regimen.

Read the detailed description

The study will start with 2-4 cycles of combination chem-free therapy with obinutuzumab, zanubrutinib and lenalidomide, followed by sequential CAR-T therapy. CAR-T therapy with AZA + FC (Azacitidine +Fludarabine +Cyclophosphamide) conditioning regimen. Targets of CAR-T cells are CD19/CD22. In this clinical trial, ORR, CRR, OS, PFS, AE and other indicators were used to observe the safety and efficacy of this sequential therapy.

Being tested
Obinutuzumab, Zanubrutinib, Lenalidomide, CD19/CD22 CAR-T, Azacitidine For Injection
Keywords
Humanized anti-CD20 monoclonal antibody, BTK Inhibitor, Immunomodulators, CAR-T
Medical subject headings
Recurrence, Lymphoma, B-Cell

What participants receive

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

  • ObinutuzumabDrug

    Also called Gazyva

    Obinutuzumab Injection 1000mg ivgtt C1-C4 d1；

  • ZanubrutinibDrug

    Also called Brukinsa

    Zanubrutinib 160mg (2 capsules) oral bid；

  • LenalidomideDrug

    Also called Anxian

    Lenalidomide 25mg (1 capsule) oral C1-C4 d1-d10.

  • CD19/CD22 CAR-TDrug

    Targets of CAR-T cells are tandem CD19/CD22. 1 * 10 ^ 7/kg dual-target CAR-T cells were reinfused with 10%, 30% and 60% of the total dose on d1, d2, d3 respectively.

  • Azacitidine For InjectionDrug

    Also called Anyve

    Azacitidine For Injection 100mg i.h. d1-d5;

  • FludarabineDrug

    Also called Fludara

    Fludarabine 300mg/m2 ivgtt d3-d5;

  • CyclophosphamideDrug

    Also called Endoxan

    Cyclophosphamide 300mg/m2 ivgtt d3-d5.

Study groups in NCT05797948
Study groupRoleWhat they receive
GZL sequential CD19/CD22 CAR-TExperimentalPhase I (combined immunotherapy period): 2-4 cycle of combination chem-free therapy with Obinutuzumab, Zanubrutinib and Lenalidomide . Each cycle is 21 days. Phase II (CAR-T therapy): CAR-T therapy with AZA + FC (Azacitidine, Fludarabine and Cyclophosphamide) conditioning regimen. Targets of CAR-T cells are CD19/CD22.
Receives: Drug: Obinutuzumab; Drug: Zanubrutinib; Drug: Lenalidomide; Drug: CD19/CD22 CAR-T; Drug: Azacitidine For Injection; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

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

  1. Overall response rate (ORR) after GZL therapy

    the rate of patients who achieved CR or PR after GZL therapy

    Measured: At the end of GZL therapy (2-4 cycles, each cycle is 21days)

  2. Complete response rate (CRR) after CAR-T

    the best rate of patients who achieved CR after CAR-T therapy

    Measured: Within 3 months after CAR-T therapy

  3. Progression-free survival (PFS) after CAR-T

    PFS will be assessed from the GZL combination therapy given to date of progression, relapse, death or end of follow-up.

    Measured: up to 24 months after the end of last patient's treatment

Secondary outcomes (4)

  1. Incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events

    The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Event.

    Measured: Initiation of GZL therapy until 30 days after CAR-T therapy

  2. Overall response rate (ORR) after CAR-T

    The best rate of patients who achieved CR or PR after CAR-T therapy

    Measured: Within 3 months after CAR-T therapy

  3. Overall survival (OS) after CAR-T

    OS will be assessed from the GZL combination therapy given to date of death or end of follow-up.

    Measured: up to 24 months after the end of last patient's treatment

  4. Duration of Response(DOR) after CAR-T

    DOR will be assessed from the date of CAR-T infusion to the date of progression, relapse, death or end of follow-up

    Measured: up to 24 months after the end of last patient's treatment

Timeline

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

  1. First posted4 Apr 2023
  2. Study start1 Jul 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797948
Sponsor's protocol ID
GZL
Status last verified
Feb 2023
First submitted
22 Mar 2023
Last updated
4 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All the data would be available at the First Affiliated Hospital and other researchers after the end of the study.

Questions about this trial

What is this clinical trial studying?

A study testing Obinutuzumab, Zanubrutinib and Lenalidomide in people with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma, run by The First Affiliated Hospital of Soochow 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 12 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Apr 2023. 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.

Are results available for this study?

Results are not available in the source record.

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?

Overall response rate (ORR) after GZL therapy (time frame: At the end of GZL therapy (2-4 cycles, each cycle is 21days)). 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 NCT05797948.

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 4 Apr 2023.

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