Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseases

NCT05239702 | Unknown Early Phase 1 DMC

• 1 other identifier: CD7-002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study on the Safety and Effectiveness of Targeting CD7 Chimeric Antigen Receptor T Cells in the Treatment of Autoimmune Diseases

Conditions

Crohn Disease; Ulcerative Colitis; Dermatomyositis; Still Disease; Autoimmune Diseases

Keywords

CAR T-cell therapy; CD7; Crohn disease; Ulcerative colitis; Dermatomyositis; Still disease; Refractory autoimmune disease

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 CD7 targeted CAR T-cells infusion

• Incidence of treatment-emergent adverse events (TEAEs)

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

  Up to 2 years after CD7 targeted CAR T-cells infusion

Secondary Outcomes (5)

• Overall response rate (ORR)

  At Month 1, 3, 6, 12, 18, 24

• Best overall response, BOR

  At ≤3 month

• Concentration of CAR-T cells

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

• Duration of remission, DOR

  2 years post CD7 CAR-T cells infusion

• Overall survival (OS)

  From CD7 CAR-T infusion to death，up to 2 years

Study Arms (5)

Crohn Disease

EXPERIMENTAL

Biological: CD7 CAR T-cells

Ulcerative Colitis

EXPERIMENTAL

Biological: CD7 CAR T-cells

Dermatomyositis

EXPERIMENTAL

Biological: CD7 CAR T-cells

Still Disease

EXPERIMENTAL

Biological: CD7 CAR T-cells

Autoimmune Diseases

EXPERIMENTAL

Biological: CD7 CAR T-cells

Interventions

CD7 CAR T-cells BIOLOGICAL

Each subject receive CD7 CAR T-cells by intravenous infusion

Also known as: CD7 CAR-T cells injection

Autoimmune Diseases; Crohn Disease; Dermatomyositis; Still Disease; Ulcerative Colitis

Eligibility Criteria

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

You may qualify if:

• Diagnosed as refractory Crohn disease, ulcerative colitis (collectively called Crohn's disease), and the conventional hormone therapy is not effective and (or) there is no effective treatment:
• At least 6 months before screening, diagnosed as Crohn's disease based on typical radiological results and/or typical histology.
• In addition to corticosteroids, after the use of immunosuppressive agents (usually azathioprine, methotrexate, and two biological agents (usually infliximab, adalimumab and/or setolizumab), the course of the disease is still Unsatisfactory. Patients should still have relapsed and refractory diseases after glucocorticoid and/or immunosuppressive treatment, or clearly show intolerance/toxicity to these drugs
• Diagnosed as refractory dermatomyositis, and conventional hormone therapy is not effective and (or) ineffective treatment methods:
• At least 6 months before screening, confirmed or possible dermatomyositis according to Bohan and Peter criteria;
• At least it has no response to prednisone and other first-line immunosuppressants (such as methotrexate, mycophenolate mofetil, or azathioprine), or has obvious toxicity or intolerance to these therapies.
• Refractory adult STILL disease
• Conform the diagnostic criteria for adult STILL disease (according to Yamaguchi et al., J. Rheumatology, 1992);
• After receiving non-steroidal anti-inflammatory drugs, glucocorticoids, anti-rheumatic drugs (DMARDs) and other treatments, there are still relapsed and refractory diseases, or clearly show that these drugs are intolerant/toxic.
• Rheumatoid arthritis
• Conform the diagnostic criteria for rheumatoid arthritis in 2010 ACR classification criteria;
• Have received DMARDs or glucocorticoid therapy, but failed to achieve clinical remission, or clearly showed intolerance/toxicity to these drugs.
• The following screening can be performed by meeting any of the above 4 entry criteria
• 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;

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;
• Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
• Those who have used any gene therapy products before.
• The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
• Those who suffer from other uncontrolled diseases are not suitable to join the study;
• HIV infection;
• Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Sponsors & Collaborators

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

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Dermatomyositis; Arthritis, Juvenile; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Immune System Diseases

Study Officials

• He Huang, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, PhD

CONTACT

+8613605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

+8615957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The President of The First Affiliated Hospital, College of Medicine, Zhejiang University

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: February 15, 2022
• Study Start: February 28, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

CN (1)