NCT06646666

ARTA-based Chemo-free Bridging/Maintenance Therapy in CAR-T Treatment for High-Risk R/R B-NHL Ineligible for HDCT and ASCT

Efficacy and Safety of All-trans Retinoic Acid (ATRA)-Based Chemo-free Bridging/Maintenance Therapy in CAR-T Treatment of High-risk Relapsed/Refractory B-NHL Ineligible for High-dose Chemotherapy （HDCT） and Autologous Stem Cell Transplantation （ASCT）

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, prospective study enrolling high-risk (tumor diameter \> 4 cm) relapsed/refractory B-NHL patients ineligible for HDCT and ASCT. The treatment consists of ATRA combined with zanubrutinib ± radiotherapy and CAR-T therapy. Based on the efficacy at day 28 post-CAR-T infusion, patients achieving CR will receive 3 months of ATRA and zanubrutinib, while those with PR will receive 3 months of zanubrutinib plus 2 years of ATRA and a PD-1 inhibitor. Patients with stable disease or progression will discontinue. The primary endpoint is the 3-month CR rate following CAR-T infusion.

Conditions

• B-cell Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	All-trans retinoic acid	10mg，tid，po (After apheresis and continued until post-infusion)
DRUG	zanubrutinib	160mg，bid，po (prior to apheresis and continued until post-infusion)
RADIATION	radiotherapy	If the patient's specific lesions are suitable for radiotherapy
DRUG	CAR-T	CAR-T cell therapy
DRUG	PD-1 inhibitor	IV 200 mg on D1, Q3W

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2024-10-17
• Last updated: 2024-11-01

Locations

1 site across 1 country: China