Efficacy and Safety of Zuberitamab Combined with Bendamustine, Followed by Monotherapy Maintenance, in Treatment-naïve Follicular Lymphoma

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 2

Conditions: Follicular Lymphoma (FL)

Treatments: Drug: Zuberitamab; Drug: Bendamustine

Study type: Interventional

Funder types: Other

Identifiers

NCT06757894

B2024-815-01

Details and patient eligibility

About

This is a prospective, single-arm, multicenter, phase ll clinical trial to evaluate the efficacy and safety of Zuberitamab and Bendamustine combination treatment in treatment-naïve follicular lymphoma patients.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntary signing of informed consent.

2. Age ≥ 18 years, no gender restriction.

3. Histologically confirmed follicular lymphoma (grades 1-3a), CD20 positive by immunohistochemistry.

4. No prior systemic treatment for FL.

5. Ann Arbor stage III/IV, or stage II with bulky disease (bulky disease defined as a tumor diameter ≥ 7 cm).

6. Presence of measurable lesions.

7. Meeting any of the following criteria:

   1. B symptoms: unexplained fever >38°C, night sweats, unexplained weight loss >10% in the last 6 months.
   2. Abnormal signs: splenomegaly, pleural effusion, ascites, etc.
   3. Major organ damage: involvement of major organs leading to organ dysfunction.
   4. Hematologic involvement: cytopenia [WBC < 1.0 × 10⁹/L and/or PLT < 100 × 10⁹/L]; leukemia-like manifestations (malignant cells > 5.0 × 10⁹/L); elevated LDH levels; HGB < 120 g/L; β2-microglobulin ≥ 3 mg/L.
   5. Bulky disease: involvement of ≥ 3 tumors with each diameter ≥ 3 cm, or any lymph node or extranodal tumor with diameter ≥ 7 cm (for Ann Arbor stage III-IV patients).
   6. Tumor enlargement of 20%-30% within 2-3 months, or approximately 50% enlargement within 6 months.

8. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

9. Expected survival of > 6 months.

Exclusion criteria

1. History of allergy to any component of monoclonal antibodies or investigational drugs.
2. Central nervous system involvement.
3. History of previous malignant tumors.
4. Clinically significant cardiac or pulmonary diseases.
5. Infection requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to enrollment; or infection requiring oral antibiotics within 2 weeks prior to enrollment; or symptoms related to an infection within 1 week prior to enrollment.
6. Major surgery within 4 weeks prior to enrollment.
7. Vaccination with live vaccines within 4 weeks prior to enrollment or planned live vaccination during the study.
8. HIV antibody positive.
9. Active syphilis infection, TP antibody positive, and anti-TP treatment within the last 2 years.
10. Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test result exceeding the detection limit; Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, with Hepatitis B virus DNA quantitative test result exceeding the detection limit (for patients with HBsAg or HBcAb positive status, regardless of HBV-DNA detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial).
11. Pregnant or breastfeeding women, or planning to become pregnant during the study.
12. Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Zuberitamab and Bendamustine Combination Treatment

Experimental group

Description:

Induction therapy: 1. Zuberitamab: 375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6). 2. Bendamustine: 90 mg/m², administered on D1-2 of C1-C6. Each cycle lasts 28 days. After 6 cycles of treatment, patients who achieve complete remission (CR) or partial remission (PR) will continue with maintenance therapy. Maintenance therapy: Zuberitamab: 375 mg/m², administered once every 2 months, until disease progression or for a maximum of 24 months (12 doses).

Treatment:

Drug: Bendamustine

Drug: Zuberitamab