Trials Sponsors Conditions Drugs Pricing

Conditions

Autoimmune Diseases Refractory to Standard Therapies

Keywords

Autoimmune DiseasesRefractory to Standard Therapies

Outcome Measures

Primary Outcomes (1)

The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)
TEAEs and DLTs will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria
DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 12 months post-treatment.

Secondary Outcomes (3)

Objective Response Rate (ORR), Disease control rate (DCR)
Week 4, Month 3, Month 6 and Month 12
Pharmacokinetic (PK) of RN1201
up to 12 months
Pharmacodynamic (PD) of RN1201
up to 12 months

Study Arms (1)

allogeneic CAR-T cell therapy

EXPERIMENTAL

RN1201 cells injection will be infused only once intravenously at day 0

Biological: allogeneic CAR-T

Interventions

allogeneic CAR-TBiological

Fludarabine injection (30 mg/m2，QD×3d) and cyclophosphamide injection (300 mg/m2，QD×3d)will be used to remove the lymphocyte before RN1201 infusion.

allogeneic CAR-T cell therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntary signed informed consent demonstrating understanding of the study and willingness/ability to comply with all trial procedures.
Age ≥18 years; both sexes eligible.

Sponsors & Collaborators

The First Affiliated Hospital with Nanjing Medical University
Otherlead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Lei FanCONTACT086+025-68306124 fanlei@jsph.org.cn

Lei FanPRINCIPAL INVESTIGATOR

Xiaoyan QuSUB INVESTIGATOR

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

Lei Fan
The First Affiliated Hospital with Nanjing Medical University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Fan

CONTACT

086+025-68306124 fanlei@jsph.org.cn

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director of lymphoma center

Study Record Dates

First Submitted

July 24, 2025

First Posted

August 6, 2025

Study Start

August 15, 2025

Actual (reported)

Primary Completion

August 2027

Estimated

RN1201 Injection for Autoimmune Diseases Refractory to Standard Therapies

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

allogeneic CAR-T cell therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

allogeneic CAR-T cell therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations