CMV-TCR-T Cells for CMV Infection After Allogenic HSCT

NCT05140187 | Unknown Phase 1

• 1 other identifier: S2021-344-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after allogenic HSCT.

Conditions

CMV Infection After Allogenic HSCT

Keywords

CMV; HSCT

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Percentage of participants with adverse events.

  1 year

Secondary Outcomes (2)

• Changes of CMV-DNA copies number

  1 year

• Persistence of CMV-TCR-T cells

  1 year

Study Arms (1)

CMV-TCR-T cells

EXPERIMENTAL

The patients with CMV infection after HSCT will receive one to three infusions of donor-derived CMV-TCR-T cells, with the escalated dose ranging from 1×10\^3/kg to 5×10\^5/kg CMV-TCR-T cells per dose.

Biological: CMV-TCR-T cells

Interventions

CMV-TCR-T cells BIOLOGICAL

The patients with CMV infection after HSCT will receive one to three doses of donor-derived CMV-TCR-T cells, with the escalated doses including 1×10\^3/kg, 1×10\^5/kg, and 5×10\^5/kg CMV-TCR-T cells per dose.

CMV-TCR-T cells

Eligibility Criteria

• Age: 1 Year - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 1-60 years, gender unlimited.
• Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with CMV infection after allo-HSCT.
• Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
• \) Age ≥ 8 years; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8\~4) × 10\^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.

You may not qualify if:

• Patients with active aGVHD one day before TCR-T cell infusion.
• Patients with severe kidney disease (Cr \> 3×normal value), liver damage (TBIL \>2.5×upper limit of normal value, ALT and AST \> 3×upper limit of normal value) or heart failure (NYHA heart function grade IV) one week before TCR-T cell infusion.
• Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
• Have other malignancies.
• Have relapsed and uncontrolled hematologic malignancies.
• Serologically positive for HIV-Ab or TAP-ab.
• Pregnant or lactating women.
• Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.
• Participated in any other clinical study of drugs and medical devices before 30 days of enrollment.
• \. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
• Positive for any of the following: HbsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA;
• Other uncontrolled infection;
• Have taken immunosuppressive drugs 1 week before PBMC collection;
• Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

• Ma C, Chen P, Du J, Wang L, Lu N, Sun J, Qilong X, Wang Y, Dou L, Liu DH. Adoptive transfer of CMV-specific TCR-T cells for the treatment of CMV infection after haploidentical hematopoietic stem cell transplantation. J Immunother Cancer. 2024 Jan 6;12(1):e007735. doi: 10.1136/jitc-2023-007735.

  PMID: 38184303 DERIVED

Study Officials

• Daihong Liu

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daihong Liu

CONTACT

86-13681171597; daihongrm@163.com

Liping Dou

CONTACT

86-13681207138; lipingruirui@163.com

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

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: October 15, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CN (1)