To hear about similar clinical trials, please enter your email below
Trial Title:
Allogeneic γ9δ2 T Cells Treatment of Recurrent Hematologic Tumors
NCT ID:
NCT05755854
Condition:
Hematologic Diseases
Conditions: Official terms:
Hematologic Diseases
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Conditions: Keywords:
Recurrent hematologic tumors
Allogenic γδT Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
allogeneic γ9δ2 T Cells
Description:
dose escalation (3+3) : dose 1 (5 × 10^7cells/kg) ,dose 2 (1 × 10^8 cells/kg) ,dose 3 (2
× 10^8cells/kg)
Arm group label:
Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Intravenous fludarabine on days-5 and -4,the infusion dose is adjusted according to the
subject's condition
Arm group label:
Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation
Other name:
Fludarabine Phosphate for Injection
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Intravenous cyclophosphamide on days -5、-4、and -3, the infusion dose is adjusted
according to the subject's condition
Arm group label:
Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation
Other name:
Cyclophosphamide for Injection
Intervention type:
Drug
Intervention name:
Zoredronic acid
Description:
Intravenous zoredronic acid 50ug/kg 24 hours before cell infusion（or according to the
dosage of the instruction）（If applicable）
Arm group label:
Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 12-65 (inclusive)；
2. Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell
transplantation；
3. 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；
4. No obvious hereditary disease;
5. Normal cardiac function, cardiac ejection index above 55%;
6. 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;
7. Sign informed consent.
Exclusion Criteria:
1. Patients with simple extramedullary recurrence;
2. Pregnant and lactating women;
3. Organ failure;
- Heart: Ⅲ level and Ⅳ level;
- Liver: reach the grade C Child - Turcotte liver function;
- Kidney, renal failure and uremia period;
- Lung: symptoms of severe respiratory failure;
- Brain: consciousness disorder.
4. Patients with a history of solid organ transplantation;
5. 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;
6. Patients with systemic autoimmune diseases or primary immunodeficiency;
7. Patients with allergic constitution;
8. Use of systemic steroid drugs;
9. Chronic diseases requiring the use of immunological agents or hormone herapy;
10. Prior treatment with any other immune cells;
11. Participated in similar clinical trials within 30 days;
12. Received radiation therapy within 4 weeks from the time of enrollment;
13. Researchers don't think clinical trials are appropriate for other reasons.
Gender:
All
Minimum age:
12 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230036
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhu Xiaoyu, Ph.D
Phone:
+86 15255456091
Email:
xiaoyuz@ustc.edu.cn
Contact backup:
Last name:
Sun Guangyu
Phone:
+86 13956970687
Email:
sunguangyu_vip@foxmail.com
Start date:
May 3, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755854
