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RECRUITING
NCT07775508
PHASE1

In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed/Refractory B-Cell Lymphoma

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

This Phase 1, open-label, single-arm, dose-escalation study is designed to evaluate the safety and tolerability of SL1617 Injection in patients with relapsed or refractory B-cell lymphoma. SL1617 is an investigational in vivo CAR T-cell immunotherapy targeting CD19 and CD20, utilizing an engineered lentiviral vector to generate functional CAR-T cells in vivo without the need for ex vivo cell processing or lymphodepletion. Participants will receive a single intravenous infusion of SL1617 using a traditional 3+3 dose-escalation design. The planned starting dose is 1.0 × 10\^9 transducing units (TU), followed by dose levels of 3.0 × 10\^9 TU and 6.0 × 10\^9 TU. Dose escalation will be guided by the occurrence of dose-limiting toxicities (DLTs).

Official title: A Clinical Study on the Safety of in Vivo- CAR-T Cell Immunotherapy Targeting CD19/CD20 for the Treatment of Relapsed/Refractory B-cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-06-01

Completion Date

2029-01-01

Last Updated

2026-08-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

SL1617 Injection

Participants with relapsed or refractory B-cell lymphoma will receive SL1617 Injection, an investigational in vivo CD19/CD20-targeted CAR T-cell immunotherapy, by intravenous infusion according to the protocol. Participants will subsequently undergo safety and efficacy assessments for up to 24 months after treatment.

Locations (1)

Chinese PLA General Hospital, Beijing, Beijing 100853

Beijing, China