A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

NCT05085444 | Unknown Early Phase 1 DMC

• 1 other identifier: CD19/BCMA-002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

Conditions

Scleroderma; Autoimmune Diseases

Keywords

Scleroderma; CD19 CAR T-cell therapy; BCMA CAR T-cell therapy

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Baseline up to 28 days after CD19/BCMA CAR T-cells infusion

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

  Up to 90 days after CD19/BCMA CAR T-cells infusion

Secondary Outcomes (6)

• Concentration of CAR-T cells

  From admission to the end of the follow-up, up to 2 years

• Objective Response Rate, ORR

  In 3 months of CD19/BCMA CAR-T cell infusion

• Disease control rate, DCR

  From Day 28 CD19/BCMA CAR-T infusion up to 2 years

• Duration of remission, DOR

  24 months post CD19/BCMA CAR-T cells infusion

• Progression-free survival, PFS

  24 months post CD19/BCMA CAR-Tcells infusion

Study Arms (1)

Treatment of Scleroderma

EXPERIMENTAL

Experimental：Administration of CD19/BCMA CAR T-cells A dose levels of 1-4\*10E6/kg are administrated for each subject.

Biological: Assigned Interventions CD19/BCMA CAR T-cells

Interventions

Assigned Interventions CD19/BCMA CAR T-cells BIOLOGICAL

Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection

Treatment of Scleroderma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Scleroderma with positive CD19/BCMA expression , and the conventional treatment is not effective and (or) no effective treatment
• Estimated survival time\> 12 weeks;
• Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
• Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

You may not qualify if:

• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Pregnant (or lactating) women;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
• Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
• Other uncontrolled diseases that were not suitable for this trial;
• Patients with HIV infection;
• Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
• Platelets ≥30×10E9/L, and absolute lymphocyte count ≥1.0×10E9/L
• Methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg) instead of immunosuppressive agents to control the disease.

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Immune System Diseases

Study Officials

• He Huang, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, PhD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 20, 2021
• Study Start: October 8, 2021
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

CN (1)