Clinical trial
Adoptive Immunotherapy With Donor-derived CMV-TCR-T Cells for Patients With CMV Infection After Allogenic HSCT
Name
S2021-344-01
Description
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.
Trial arms
Trial start
2021-10-15
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
CMV-TCR-T cells
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.
Arms:
CMV-TCR-T cells
Size
12
Primary endpoint
Adverse events
1 year
Eligibility criteria
Inclusion Criteria:
1. Age 1-60 years, gender unlimited.
2. Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with CMV infection after allo-HSCT.
3. Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
4. TCR-T cell donor inclusion criteria:
1) 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.
Exclusion Criteria:
1. Patients with active aGVHD one day before TCR-T cell infusion.
2. 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.
3. Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
4. Have other malignancies.
5. Have relapsed and uncontrolled hematologic malignancies.
6. Serologically positive for HIV-Ab or TAP-ab.
7. Pregnant or lactating women.
8. Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.
9. Participated in any other clinical study of drugs and medical devices before 30 days of enrollment.
11. 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.
12. TCR-T cell donor exclusion criteria:
1. Positive for any of the following: HbsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA;
2. Other uncontrolled infection;
3. Have taken immunosuppressive drugs 1 week before PBMC collection;
4. Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}
Updated at
2023-03-29
1 organization
1 product
1 indication
Organization
Chinese PLA General HospitalProduct
CMV-TCR-T cells