Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
NCT ID:
NCT07031700
Eligibility Criteria:
Inclusion Criteria:
1. Signed written informed consent.
2. Age ≥18 years.
3. Histologically confirmed relapsed/refractory follicular lymphoma (r/r FL).
4. Received at least two prior systemic therapies, including anti-CD20 monoclonal antibody therapy.
5. ECOG performance status 0-1.
6. Expected survival ≥12 weeks.
7. Measurable disease (longest diameter \>1.5 cm).
8. Adequate organ function:
* Hepatic function: Total bilirubin ≤1.5×ULN; AST/ALT ≤3×ULN.
* Hematologic function: ANC ≥1.5 × 10⁹/L; Platelets ≥75,000/μL; Hemoglobin ≥10.0 g/dL.
* Renal function: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min (Cockcroft-Gault formula).
9. Women of childbearing potential must have a negative serum pregnancy test and agree to use contraception.
Exclusion Criteria:
1. Inability to comply with study hospitalization and restrictions.
2. Active infections (including tuberculosis) or immunocompromised status.
3. Prior history of severe hypersensitivity to similar agents.
4. CNS involvement of lymphoma.
5. Pregnant or breastfeeding women.
6. Uncontrolled comorbid conditions, including cardiovascular or autoimmune diseases.
7. Receipt of live attenuated vaccines within 4 weeks before enrollment.
8. Use of systemic immunosuppressants within 2 weeks prior to first dose.
9. History of drug or alcohol abuse in the past 12 months.
10. Any condition deemed inappropriate for study participation by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07031700
Study Brief:
Protocol Section:
NCT07031700