RN1201injection for Relapsed/Refractory B-cell Hematologic Malignancies

Not Applicable

Not yet recruiting

• Conditions: Relapsed or Refractory B-cell Hematologic Malignancies
• Interventions: Biological: Allogeneic CAR-T

• Registration Number: NCT07113496
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory B-cell hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status. The trial assesses overall response and disease control rates, treatment-emergent adverse events, and in vivo behavior of UCAR-T cells.

Detailed Description

This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory B-cell hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status.Primary endpoints include treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), pharmacokinetics, and pharmacodynamics of UCAR-T. This study aims to provide initial evidence for the safety and anti-tumor activity of UCAR-T in hematologic malignancies.

Study Timeline

• Study First Submitted: 2025-07-24
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-02
• Last Update Submitted: 2025-08-02
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Primary Completion: 2027-08
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allogeneic CAR-T cell therapy	Allogeneic CAR-T	RN1201 cells injection will be infused only once intravenously

Primary Outcome Measures

Name	Time	Method
The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)	DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 12 months post-treatment.	TEAEs and DLTs will be graded according to CTCAE v5.0 and ASTCT consensus criteria

Secondary Outcome Measures

Name	Time	Method
Tmax of RN1201	Up to 12 months	Time to maximum concentration of RN1201
Cytokines in the peripheral blood after RN1201 infusion	Up to 12 months	Serum concentrations of interleukin (IL)-2, IL-6, IL-8, IL-10, interferon-gamma (IFN-γ), and TNF-α
Cmax of RN1201	Up to 12 months	peak plasma concentration of CAR - T cells copy number and the positive rate
Objective Response Rate (ORR), Disease control rate (DCR)	Week 4, Month 3, Month 6 and Month 12
Progression-free survival (PFS)	Week 4, Month 3, Month 6 and Month 12	PFS defned as the time from the date of RN1201 infusion to the frst assessment of confrmed disease progression or death
Overall survival (OS)	Week 4, Month 3, Month 6 and Month 12	OS defned as the time from the date of RN1201 infusion to death

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China