CMV Infection or Reactivation After Allogenic HSCTPhase 1NCT04153279
CMV-TCR-T Cells for CM Virus Infection After HSCT
A Phase 1 study testing CMV-TCR-T cells in people with CMV Infection or Reactivation After Allogenic HSCT, run by Hebei Yanda Ludaopei Hospital at 1 site in China.
Trial summary
This is a single cente, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after HSCT. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- CMV Infection or Reactivation After Allogenic HSCT
- What is being tested?
- CMV-TCR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2019to 15 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 1-70 years, including boundary values, gender unlimited;
- Allogenic hematopoietic stem cell transplantation patients with CMV infection disease or persistent CMV emia;
- At least one of the following conditions after allogeneic HSCT:
- After trested with 2-week standard antiviral drug, compared to the baseline of treatment, the decrease of CMV DNA copies number was less than 1log10, and the CMV DNA copies number is greater than 1000 copies/ mL ;
- Unable to tolerate the toxic and side effects of antiviral drugs,such as bone marrow hematopoietic suppression, nephrotoxicity;
- Estimated life expectancy ≥3 months；
- ECOG 3;
- Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.
Who cannot join
- Patients with active aGVHD III-IV and / or mild and severe cGVHD;
- Received cell therapy such as DLI,CTL,CAR-T or participated in any other clinical study of drugs and medical devices before 30 days of enrollment.
- Pregnant or lactating women;
- Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation;
- patients with organ failure:
- Heart: NYHA heart function grade IV;
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- Liver: Grade C that achieves Child-Turcotte liver function grading;
- Kidney: kidney failure and uremia;
- Lung: symptoms of respiratory failure;
- Brain: a person with a disability;
- The researchers found that it was unsuitable for the recipients to be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of CMV-TCR-T Cells in CM Virus Infection Diseases After HSCT
This is a single cente, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after HSCT.
Read the detailed description
CMV infection is a common virus infection of HSCT, and which is highly related with the failure of transplantation and survival time of transplant patients. To evaluate the safety and efficacy of allogenic CMV-TCR-T cell therapy in subjects with CMV infection, patients with CMV emias or deseases will be enrolled, and donor derived CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).
- Being tested
- CMV-TCR-T cells
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV-TCR-T cellsBiological
Patients with CMV emias or CMV disease will be enrolled, and donor derived CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 28).
| Study group | Role | What they receive |
|---|---|---|
| CMV-TCR-T cells | Experimental | The patients will receive one dose of CMV-TCR-T.The dosage ranges from 0.1×10^6 to 1×10^6 TCR+T/Kg. Receives: Biological: CMV-TCR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adverse events
Percentage of participants with adverse events.
Measured: 3months
Secondary outcomes (2)
Persistence of TCR-T cells
Measured: 3months
Changes of CMV-DNA copies number
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start19 Dec 2019
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CMV Infection or Reactivation After Allogenic HSCTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Yanda Ludaopei Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Xingyu Cao, Ph.D, Study director, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153279
- Sponsor's protocol ID
- HXYT-005
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2019
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu G, Chen H, Cao X, Jia L, Rui W, Zheng H, Huang D, Liu F, Liu Y, Zhao X, Lu P, Lin X. Efficacy of pp65-specific TCR-T cell therapy in treating cytomegalovirus infection after hematopoietic stem cell transplantation. Am J Hematol. 2022 Nov;97(11):1453-1463. doi: 10.1002/ajh.26708. Epub 2022 Sep 22.
PubMed 36054234
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of CMV-TCR-T Cells in CM Virus Infection Diseases After HSCT
- ClinicalTrials.gov ID
- NCT04153279
- Acronym / sponsor ID
- HXYT-005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hebei Yanda Ludaopei HospitalUniversity, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single cente, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after HSCT.
Detailed description
CMV infection is a common virus infection of HSCT, and which is highly related with the failure of transplantation and survival time of transplant patients. To evaluate the safety and efficacy of allogenic CMV-TCR-T cell therapy in subjects with CMV infection, patients with CMV emias or deseases will be enrolled, and donor derived CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMV-TCR-T cells | Experimental | Biological: CMV-TCR-T cellsThe patients will receive one dose of CMV-TCR-T.The dosage ranges from 0.1×10^6 to 1×10^6 TCR+T/Kg. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 1-70 years, including boundary values, gender unlimited;
- Allogenic hematopoietic stem cell transplantation patients with CMV infection disease or persistent CMV emia;
- At least one of the following conditions after allogeneic HSCT:
- Estimated life expectancy ≥3 months；
- ECOG 3;
Key exclusion criteria (11 listed)
- Patients with active aGVHD III-IV and / or mild and severe cGVHD;
- Received cell therapy such as DLI,CTL,CAR-T or participated in any other clinical study of drugs and medical devices before 30 days of enrollment.
- Pregnant or lactating women;
- Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation;
- patients with organ failure:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMV-TCR-T cellsPatients with CMV emias or CMV disease will be enrolled, and donor derived CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 28). | Biological | CMV-TCR-T cells |
Primary outcome
Percentage of adverse events
Time frame: 3months
Percentage of participants with adverse events.
2 secondary outcomes
Persistence of TCR-T cells
Time frame: 3months
Changes of CMV-DNA copies number
Time frame: 3months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 36054234Liu G, Chen H, Cao X, Jia L, Rui W, Zheng H, Huang D, Liu F, Liu Y, Zhao X, Lu P, Lin X. Efficacy of pp65-specific TCR-T cell therapy in treating cytomegalovirus infection after hematopoietic stem cell transplantation. Am J Hematol. 2022 Nov;97(11):1453-1463. doi: 10.1002/ajh.26708. Epub 2022 Sep 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xingyu Cao, Ph.D study director
Hebei Yanda Ludaopei Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CMV-TCR-T cells in people with CMV Infection or Reactivation After Allogenic HSCT, run by Hebei Yanda Ludaopei Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adverse events (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04153279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.