A Phase I Clinical Trial of RS001 in Patients with Relapsed/Refractory B-Cell Malignancies

Sponsor
Guangdong Ruishun Biotech Co., Ltd
Study ID
NCT06894693
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • RS001 injection — BIOLOGICAL
    CD19-CAR-mbIL15-DNT Cells.

Study Details

This study is an open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic profile in the body after infusion of RS001 injection, and preliminary efficacy in subjects with CD19-positive relapsed/refractory B-cell malignancies (BCM).

Key Dates

First listed
Mar 25, 2025
Start date
Apr 1, 2025
Status verified
Mar 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2028

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RS001 injection
    The trial is divided into two parts: Part A is a dose escalation trial with three dose groups (5×10\^6 CAR+ cells/kg, 1×10\^7 CAR+ cells/kg and 2×10\^7 CAR+ cells/kg at day 0), with 7-18 patients planned to be enrolled. Part B is a dose-expansion trial in which 6\~12 patients will receive RS001 infusions at RP2D dose levels.

Primary Outcome Measure

Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]

Central Contacts

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