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NOT YET RECRUITING
NCT06646666
PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2024-12-01

Completion Date

2027-12-01

Last Updated

2024-11-01

Healthy Volunteers

No

Interventions

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

Locations (1)

Department of Hematology, Shanghai Institute of Hematology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China