Hematologic DiseasesPhase 1NCT05755854
Allogeneic γ9δ2 T Cells Treatment of Recurrent Hematologic Tumors
A Phase 1 study testing allogeneic γ9δ2 T Cells, Fludarabine and Cyclophosphamide in people with Hematologic Diseases, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This is an open single-arm clinical study aimed at evaluating the safety and tolerance of allogeneic γ9δ2 T cell injection in the treatment of patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- allogeneic γ9δ2 T Cells, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2023to 31 Dec 2025
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12-65 (inclusive)；
- Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation；
- Basically normal liver and kidney function (as demonstrated by the following laboratory tests prior to initial γ9δ2 T cell therapy)
- Alanine transaminase/aspartate transaminase < 2.5×ULN；
- serum creatinine < 1.5×ULN；
- total bilirubin level < 1.5×ULN；
Show all 10Show fewer
- No obvious hereditary disease;
- Normal cardiac function, cardiac ejection index above 55%;
- Women of reproductive age (15 to 49 years) must undergo a pregnancy test within 7 days before starting treatment and the result is negative, and use contraception during the clinical trial period and within 3 months after the last cell transfusion;
- Sign informed consent.
Who cannot join
- Patients with simple extramedullary recurrence;
- Pregnant and lactating women;
- Organ failure;
- Heart: Ⅲ level and Ⅳ level;
- Liver: reach the grade C Child - Turcotte liver function;
- Kidney, renal failure and uremia period;
Show all 18Show fewer
- Lung: symptoms of severe respiratory failure;
- Brain: consciousness disorder.
- Patients with a history of solid organ transplantation;
- Uncontrollable infectious diseases or other serious diseases, including but not limited to infections (such as HIV positive), congestive heart failure, unstable angina, arrhythmia, psychosis, or restricted social circumstances or those that the attending physician considers to pose unpredictable risks;
- Patients with systemic autoimmune diseases or primary immunodeficiency;
- Patients with allergic constitution;
- Use of systemic steroid drugs;
- Chronic diseases requiring the use of immunological agents or hormone herapy;
- Prior treatment with any other immune cells;
- Participated in similar clinical trials within 30 days;
- Received radiation therapy within 4 weeks from the time of enrollment;
- Researchers don't think clinical trials are appropriate for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230036
Zhu Xiaoyu, Ph.D, +86 15255456091, xiaoyuz@ustc.edu.cn
Sun Guangyu, +86 13956970687, sunguangyu_vip@foxmail.com
About this study
Official title: Allogeneic γ9δ2 T Cells for the Treatment of Recurrent Hematologic Tumors After Allogeneic Hematopoietic Stem Cell Transplantation
This is an open single-arm clinical study aimed at evaluating the safety and tolerance of allogeneic γ9δ2 T cell injection in the treatment of patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation.
Read the detailed description
To evaluate the safety and in vivo dynamics of allogeneic γ9δ2 T cell in the treatment of recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation patients, and to explore the appropriate therapeutic dose.
- Conditions
- Hematologic Diseases
- Being tested
- allogeneic γ9δ2 T Cells, Fludarabine, Cyclophosphamide, Zoredronic acid
- Keywords
- Recurrent hematologic tumors, Allogenic γδT Cell
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic γ9δ2 T CellsBiological
dose escalation (3+3) : dose 1 (5 × 10^7cells/kg) ,dose 2 (1 × 10^8 cells/kg) ,dose 3 (2 × 10^8cells/kg)
FludarabineDrug
Also called Fludarabine Phosphate for Injection
Intravenous fludarabine on days-5 and -4,the infusion dose is adjusted according to the subject's condition
CyclophosphamideDrug
Also called Cyclophosphamide for Injection
Intravenous cyclophosphamide on days -5、-4、and -3, the infusion dose is adjusted according to the subject's condition
Zoredronic acidDrug
Intravenous zoredronic acid 50ug/kg 24 hours before cell infusion（or according to the dosage of the instruction）（If applicable）
| Study group | Role | What they receive |
|---|---|---|
| Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation | Experimental | A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, zoredronic acid depending on the patient's status, followed by investigational therapy, allogeneic γ9δ2 T Cells Receives: Biological: allogeneic γ9δ2 T Cells; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Zoredronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
AE is defined as any adverse medical event from the date of leukapheresis to 12 months after allogeneic γ9δ2 T cells infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0
Measured: 12 months
Incidence of Dose-Limiting Toxicities (DLTs)
DLT was defined as allogeneic γ9δ2 T Cells-related events with onset within first 14 days following infusion:
The development of Grade (G) III-IV acute GVHD according to the Mount Sinai Acute GVHD International Consortium criteria; The development of G3 or higher grade CRS lasting > 2 weeks; Any allogeneic γ9δ2 T cells-related AE requiring intubation; All G4 non-hematologic toxicities. Symptoms of GVHD include but are not limited to skin rash, enterocolitis with diarrhea, liver dysfunction with jaundice, fever, weight loss, etc.
Measured: First infusion date of allogeneic γ9δ2 T cells to 14 days end cell infusion
Maximum tolerated dose (MTD)
MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.
Measured: 14 days
Recommended phase 2 dose (RP2D)
The recommended dose for phase 2 was determined through phase 1 study
Measured: 14 days
Secondary outcomes (4)
Overall Survival (OS)
OS is defined as the time from allogeneic γ9δ2 T cells infusion to the date of death. Subjects who have not died by the analysis data cutoff date will be censored at their last contact date.
Measured: 12 months
Progression Free Survival (PFS)
PFS is defined as the time from the allogeneic γ9δ2 T cells infusion date to the date of disease progression assessed by investigators assessment, or death any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Measured: 12 months
Pharmacokinetics: Persistence of the allogeneic γ9δ2 T cells
Persistence of the allogeneic γ9δ2 T cells assessed by number in peripheral blood.
Measured: 14 days
Pharmacodynamics: Peak level of cytokines in serum
The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, tumor necrosis factor-α (TNF-α) etc. Peak was defined as the maximum post-baseline level of the cytokine.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start3 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xiaoyu Zhu, Anhui Provincial Hospital
- Investigators
- Zhu Xiaoyu, Ph.D, Principal investigator, Director of Hematology Department, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755854
- Sponsor's protocol ID
- QH10103-M-01（0）
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic γ9δ2 T Cells for the Treatment of Recurrent Hematologic Tumors After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05755854
- Acronym / sponsor ID
- QH10103-M-01（0）
- Conditions
- Hematologic Diseases
- Keywords
- Recurrent hematologic tumors, Allogenic γδT Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 3 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Mar 2023 (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 an open single-arm clinical study aimed at evaluating the safety and tolerance of allogeneic γ9δ2 T cell injection in the treatment of patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation.
Detailed description
To evaluate the safety and in vivo dynamics of allogeneic γ9δ2 T cell in the treatment of recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation patients, and to explore the appropriate therapeutic dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation | Experimental | Biological: allogeneic γ9δ2 T Cells, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Zoredronic acidA conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, zoredronic acid depending on the patient's status, followed by investigational therapy, allogeneic γ9δ2 T Cells |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age 12-65 (inclusive)；
- Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation；
- Basically normal liver and kidney function (as demonstrated by the following laboratory tests prior to initial γ9δ2 T cell therapy)
- No obvious hereditary disease;
- Normal cardiac function, cardiac ejection index above 55%;
Key exclusion criteria (18 listed)
- Patients with simple extramedullary recurrence;
- Pregnant and lactating women;
- Organ failure;
- Patients with a history of solid organ transplantation;
- Uncontrollable infectious diseases or other serious diseases, including but not limited to infections (such as HIV positive), congestive heart failure, unstable angina, arrhythmia, psychosis, or restricted social circumstances or those that the attending physician considers to pose unpredictable risks;
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 |
|---|---|---|
| allogeneic γ9δ2 T Cellsdose escalation (3+3) : dose 1 (5 × 10^7cells/kg) ,dose 2 (1 × 10^8 cells/kg) ,dose 3 (2 × 10^8cells/kg) | Biological | Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation |
| FludarabineAlso: Fludarabine Phosphate for InjectionIntravenous fludarabine on days-5 and -4,the infusion dose is adjusted according to the subject's condition | Drug | Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation |
| CyclophosphamideAlso: Cyclophosphamide for InjectionIntravenous cyclophosphamide on days -5、-4、and -3, the infusion dose is adjusted according to the subject's condition | Drug | Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation |
| Zoredronic acidIntravenous zoredronic acid 50ug/kg 24 hours before cell infusion（or according to the dosage of the instruction）（If applicable） | Drug | Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: 12 months
AE is defined as any adverse medical event from the date of leukapheresis to 12 months after allogeneic γ9δ2 T cells infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: First infusion date of allogeneic γ9δ2 T cells to 14 days end cell infusion
DLT was defined as allogeneic γ9δ2 T Cells-related events with onset within first 14 days following infusion: The development of Grade (G) III-IV acute GVHD according to the Mount Sinai Acute GVHD International Consortium criteria; The development of G3 or higher grade CRS lasting > 2 weeks; Any allogeneic γ9δ2 T cells-related AE requiring intubation; All G4 non-hematologic toxicities. Symptoms of GVHD include but are not limited to skin rash, enterocolitis with diarrhea, liver dysfunction with jaundice, fever, weight loss, etc.
Maximum tolerated dose (MTD)
Time frame: 14 days
MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.
Recommended phase 2 dose (RP2D)
Time frame: 14 days
The recommended dose for phase 2 was determined through phase 1 study
4 secondary outcomes
Overall Survival (OS)
Time frame: 12 months
Progression Free Survival (PFS)
Time frame: 12 months
Pharmacokinetics: Persistence of the allogeneic γ9δ2 T cells
Time frame: 14 days
Pharmacodynamics: Peak level of cytokines in serum
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
Related trials for Hematologic Diseases
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
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.
Zhu Xiaoyu, Ph.D principal investigator
Director of Hematology Department, Anhui Provincial 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 allogeneic γ9δ2 T Cells, Fludarabine and Cyclophosphamide in people with Hematologic Diseases, run by Anhui Provincial 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 10 inclusion and 18 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 22 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhu Xiaoyu, Ph.D (+86 15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: 12 months). The study lists 4 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 22 Sep 2023.