Acute Myeloid LeukemiaPhase 1/2NCT04764513
Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
A Phase 1/2 study testing Ex-vivo expanded γδ T cell infusion in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Ex-vivo expanded γδ T cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2021to Apr 2025
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation；
- Age criteria: 18-65 years;
- Weight criteria: > 40kg;
- Organ function criteria:
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%, Pulmonary function: Indoor oxygen saturation≥95%, Alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN (upper limit of normal value), Total bilirubin ≤ 1.5×ULN, Serum creatinine ≤ 1.5×ULN;
- Life expectancy of at least 4 months;
- ECOG (Eastern Cooperative Oncology Group) score ≤ 2;
- Patients able to understand and sign written informed consent.
Who cannot join
- GVHD (graft versus host disease) ≥ grade Ⅱ；
- Thrombotic microangiopathy；
- Posttransplant lymphoproliferative disorders；
- Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)；
- Patients with chronic diseases that require treatment with immune agents or hormones;
- Suffering from systemic autoimmune disease or immunodeficiency disease;
Show all 13Show fewer
- Systemic use of steroids;
- Allergic constitution;
- Hemorrhagic disease or coagulation disorders;
- Patients participating in other clinical trials within 30 days prior to enrollment;
- Patients receiving radiotherapy within 4 weeks prior to enrollment;
- Pregnant or breastfeeding women;
- According to the researcher's judgment, the patient has other unsuitable conditions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, 100853
Yan Wei, Master, +86-13146682665, 13146682665@163.com
Chunji Gao, Professor, +86-13911536256, gaochunji301@163.com
About this study
Official title: Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.
This study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation.
Read the detailed description
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T cell in patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation. γδ T cell will be separated from peripheral blood of the same donors. After expansion in vitro, they will be infused to the patients as an immunotherapy treatment.
- Being tested
- Ex-vivo expanded γδ T cell infusion
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex-vivo expanded γδ T cell infusionBiological
Also called Chemotherapy
Phase 1: Patients receive ex-vivo expanded γδ T cell (Dose escalation, 3 cohorts, x5 dose increments between cohorts, 2×10^6、 1×10^7 and 5×10^7 of cells per kg of body weight).
Phase 2: Patients receive ex-vivo expanded γδ T cell at the maximum tolerated dose determined in Phase 1.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hematological malignancies after allo-HSCT | Experimental | 1. Patients with negative minimal residual disease or stable disease:
After inclusion, patients will receive or not receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.
2. Patients with positive minimal residual disease but not hematologic relapse:
After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.
3. Patients with hematologic relapse:
After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. Receives: Biological: Ex-vivo expanded γδ T cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]
Safety of γδ T cell assessed by incidence of treatment-emergent adverse events (AEs) per patient graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Day 28 after completion of treatment
Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]
Tolerability of γδ T cell assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Day 28 after completion of treatment
Secondary outcomes (4)
Number of patients reaching Complete Remission (CR) [Efficacy]
Efficacy of ex-vivo expanded γδ T cell assessed by number of patients reaching Complete Remission (CR).
Measured: 12 months post-treatment
Overall Survival (OS) [Efficacy]
Efficacy of ex-vivo expanded γδ T cell assessed by overall survival (OS) measured in months.
Measured: 12 months post-treatment
Quality of Life (QoL)
Quality of life determined by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 'C30'.
Measured: 12 months post-treatment
Persistence of γδ T cell
Persistence of γδ T cell assessed by number in peripheral blood.
Measured: Before treatment and up to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start12 Sep 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This dose escalation study will be conducted in two phases. The first phase will have 3 cohorts(Dose escalation, x5 dose increments between cohorts, 2×10\^6、 1×10\^7/kg and 5×10\^7 of cells per kg of body weight). The second phase is an expansion cohort at the maximum tolerated dose determined in the first phase.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Chunji Gao, Professor, Principal investigator, Chinese PLA General HospitalWeidong Han, Professor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764513
- Sponsor's protocol ID
- CHN-PLAGH-BT-062
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2021
- Last updated
- 28 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.
- ClinicalTrials.gov ID
- NCT04764513
- Acronym / sponsor ID
- CHN-PLAGH-BT-062
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 21 Feb 2021 (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 study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation.
Detailed description
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T cell in patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation. γδ T cell will be separated from peripheral blood of the same donors. After expansion in vitro, they will be infused to the patients as an immunotherapy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This dose escalation study will be conducted in two phases. The first phase will have 3 cohorts(Dose escalation, x5 dose increments between cohorts, 2×10^6、 1×10^7/kg and 5×10^7 of cells per kg of body weight). The second phase is an expansion cohort at the maximum tolerated dose determined in the first phase.
| Arm | Type | Receives |
|---|---|---|
| Patients with hematological malignancies after allo-HSCT | Experimental | Biological: Ex-vivo expanded γδ T cell infusion1. Patients with negative minimal residual disease or stable disease: After inclusion, patients will receive or not receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. 2. Patients with positive minimal residual disease but not hematologic relapse: After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. 3. Patients with hematologic relapse: After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation；
- Age criteria: 18-65 years;
- Weight criteria: > 40kg;
- Organ function criteria:
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%, Pulmonary function: Indoor oxygen saturation≥95%, Alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN (upper limit of normal value), Total bilirubin ≤ 1.5×ULN, Serum creatinine ≤ 1.5×ULN;
Key exclusion criteria (13 listed)
- GVHD (graft versus host disease) ≥ grade Ⅱ；
- Thrombotic microangiopathy；
- Posttransplant lymphoproliferative disorders；
- Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)；
- Patients with chronic diseases that require treatment with immune agents or hormones;
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 |
|---|---|---|
| Ex-vivo expanded γδ T cell infusionAlso: ChemotherapyPhase 1: Patients receive ex-vivo expanded γδ T cell (Dose escalation, 3 cohorts, x5 dose increments between cohorts, 2×10^6、 1×10^7 and 5×10^7 of cells per kg of body weight). Phase 2: Patients receive ex-vivo expanded γδ T cell at the maximum tolerated dose determined in Phase 1. | Biological | Patients with hematological malignancies after allo-HSCT |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]
Time frame: Day 28 after completion of treatment
Safety of γδ T cell assessed by incidence of treatment-emergent adverse events (AEs) per patient graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]
Time frame: Day 28 after completion of treatment
Tolerability of γδ T cell assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
4 secondary outcomes
Number of patients reaching Complete Remission (CR) [Efficacy]
Time frame: 12 months post-treatment
Overall Survival (OS) [Efficacy]
Time frame: 12 months post-treatment
Quality of Life (QoL)
Time frame: 12 months post-treatment
Persistence of γδ T cell
Time frame: Before treatment and up to 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Chunji Gao, Professor principal investigator
Chinese PLA General Hospital
Weidong Han, Professor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ex-vivo expanded γδ T cell infusion in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Chinese PLA General 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 13 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: status not confirmed, as of the sponsor's last update on 28 Mar 2022. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Wei, Master (+86-13146682665, 13146682665@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (AEs)[Safety] (time frame: Day 28 after completion of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2022.