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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07316920
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary participation; full understanding of the study and provision of written informed consent obtained before any study-related procedure not part of standard care; willingness to comply with follow-up.
2. Age 18-75 years; either sex.
3. ECOG performance status 0-1.
4. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, or indolent lymphoma transformed to DLBCL; CD19 and/or CD20 positive.
5. At least one measurable lesion per Lugano criteria: nodal lesion longest diameter \>1.5 cm, extranodal lesion \>1.0 cm.
6. Prior treatment response must meet one of the following:
• Large B-cell lymphoma, grade 3B follicular lymphoma, transformed indolent lymphoma: i. Primary refractory and ineligible/unable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles.
ii. Relapse ≤12 months after achieving CR with first-line chemo-immunotherapy. iii. Relapse/progression ≤12 months after autologous HSCT. iv. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.
v. Transformed indolent lymphoma: prior chemotherapy for iNHL and ≥1 systemic regimen after transformation, fulfilling the above refractory/relapse criteria.
• Grade 1, 2, or 3A follicular lymphoma: i. Primary refractory and ineligible/unable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy.
ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.
• Mantle-cell lymphoma: i. Primary refractory and ineligible/unable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles.
ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.
7. Estimated life expectancy ≥3 months.
8. Screening laboratory values (may be repeated once):
* Hemoglobin ≥8.0 g/dL (no transfusion within 7 days).
* Platelets ≥50×10⁹/L (no transfusion within 7 days).
* ANC ≥1.0×10⁹/L (growth-factor support allowed if none within 7 days of test).
* AST/ALT ≤3×ULN (≤5×ULN if liver involvement).
* Serum creatinine ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault).
* Total bilirubin ≤2×ULN (≤3×ULN if liver involvement); except congenital bilirubin disorders (e.g., Gilbert's syndrome: direct bilirubin ≤1.5×ULN).
* INR, PT, APTT \<1.5×ULN.
9. Toxicities from prior anti-cancer therapy (except alopecia, nausea, and the above lab values) must have stabilized at baseline or resolved to ≤Grade 1.
10. WOCBP must have a negative high-sensitivity serum β-hCG pregnancy test at screening and again before the first dose of cyclophosphamide/fludarabine.
11. Subjects of reproductive potential must use effective contraception for ≥12 months after completing study therapy.
Exclusion Criteria:
* Subjects with any of the following conditions are ineligible for this trial:
1. Any malignancy other than B-cell non-Hodgkin lymphoma ever diagnosed or treated, except:
* Malignancy that received curative therapy and has shown no evidence of active disease for ≥2 years before enrolment; or
* Adequately treated non-melanoma skin cancer with no current evidence of disease.
2. Prior anti-cancer therapy within the stated windows (before lymphodepletion):
* CNS prophylaxis (e.g., intrathecal methotrexate and/or cytarabine) within 7 days;
* Cytotoxic chemotherapy or radiotherapy within 14 days;
* Small-molecule targeted or epigenetic therapy within 14 days or 5 half-lives, whichever is longer;
* Monoclonal antibody, bispecific antibody, or antibody-drug conjugate within 21 days or 5 half-lives, whichever is shorter;
* Investigational drug or invasive investigational device within 28 days (if the therapy is also investigational, the 28-day wash-out applies);
* Autologous haematopoietic stem-cell transplant or CD19-directed autologous CAR-T therapy within 100 days.
3. Any autologous cellular or gene therapy other than CD19-directed autologous CAR-T.
4. Any allogeneic cellular (including CAR-T) or gene therapy.
5. Prior allogeneic haematopoietic stem-cell transplantation.
6. Positive donor-specific antibody (DSA).
7. At least one of the following high-risk features:
* Sum of the product of perpendicular diameters (SPD) of all measurable lesions ≥100 cm²;
* Bulky disease: single mass ≥7.5 cm; mediastinal mass with maximum diameter \>1/3 of thoracic diameter;
* Obstructive/compressive emergency (e.g., bowel obstruction, vascular compression) requiring urgent intervention at screening.
8. Active CNS involvement (symptomatic or positive CSF/imaging); subjects with prior CNS disease now in remission (asymptomatic with negative CSF and imaging) are eligible.
9. Significant bleeding diathesis: gastrointestinal bleeding, haemorrhagic cystitis, coagulopathy, hypersplenism (splenomegaly on exam/US, cytopenias, hyperplastic marrow) or ongoing anticoagulation.
10. Chronic concomitant systemic corticosteroids or other immunosuppressants, except: topical, ocular, intra-articular, nasal or inhaled corticosteroids; short-course steroids for prophylaxis (e.g., contrast allergy).
11. Severe underlying medical conditions:
* Active serious viral, bacterial or uncontrolled systemic fungal infection;
* Active systemic autoimmune disease requiring therapy.
12. Significant cardiac disease:
* NYHA class III or IV congestive heart failure;
* Myocardial infarction or CABG within 6 months before enrolment;
* Clinically relevant ventricular arrhythmia or unexplained syncope not vasovagal or dehydration-related;
* Severe non-ischaemic cardiomyopathy;
* Left ventricular ejection fraction (LVEF) \<45% by echo or MUGA within 4 weeks before lymphodepletion.
13. Resting oxygen saturation \<92%.
14. Clinically relevant prior or current CNS disorder: epilepsy, seizure-like episodes, paralysis, aphasia, stroke, severe head trauma, dementia, Parkinson's disease, cerebellar disorder, organic brain syndrome or major psychiatric illness.
15. Live-attenuated vaccine within 4 weeks before screening.
16. Major surgery within 2 weeks before screening or planned within 2 weeks after study treatment (local anaesthesia allowed).
17. Positive screen for HBsAg, HBeAg, HBV DNA, HCV antibody, HCV RNA, or HIV antibody.
18. Life-threatening allergy, hypersensitivity or intolerance to study-drug excipients including, but not limited to, DMSO.
19. Lactating women.
20. Any condition that, in the investigator's opinion, renders the subject unsuitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07316920
Study Brief:
Protocol Section:
NCT07316920