Allogeneic γ9δ2 T Cells Treatment of Recurrent Hematologic Tumors

NCT ID: NCT05755854

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Hematologic Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with recurrent hematologic tumors after allogeneic hematopoietic stem cell transplantation

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

Group Type: EXPERIMENTAL

allogeneic γ9δ2 T Cells

Intervention Type: BIOLOGICAL

dose escalation (3+3) : dose 1 (5 × 10\^7cells/kg) ,dose 2 (1 × 10\^8 cells/kg) ,dose 3 (2 × 10\^8cells/kg)

Fludarabine

Intervention Type: DRUG

Intravenous fludarabine on days-5 and -4,the infusion dose is adjusted according to the subject's condition

Cyclophosphamide

Intervention Type: DRUG

Intravenous cyclophosphamide on days -5、-4、and -3, the infusion dose is adjusted according to the subject's condition

Zoredronic acid

Intervention Type: DRUG

Intravenous zoredronic acid 50ug/kg 24 hours before cell infusion（or according to the dosage of the instruction）（If applicable）

Interventions

allogeneic γ9δ2 T Cells

dose escalation (3+3) : dose 1 (5 × 10\^7cells/kg) ,dose 2 (1 × 10\^8 cells/kg) ,dose 3 (2 × 10\^8cells/kg)

Intervention Type: BIOLOGICAL

Fludarabine

Intravenous fludarabine on days-5 and -4,the infusion dose is adjusted according to the subject's condition

Intervention Type: DRUG

Cyclophosphamide

Intravenous cyclophosphamide on days -5、-4、and -3, the infusion dose is adjusted according to the subject's condition

Intervention Type: DRUG

Zoredronic acid

Intravenous zoredronic acid 50ug/kg 24 hours before cell infusion（or according to the dosage of the instruction）（If applicable）

Intervention Type: DRUG

Other Intervention Names

Fludarabine Phosphate for Injection; Cyclophosphamide for Injection

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xiaoyu Zhu

Director of Hematology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhu Xiaoyu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Director of Hematology Department, Anhui Provincial Hospital

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhu Xiaoyu, Ph.D

Role: CONTACT

xiaoyuz@ustc.edu.cn

+86 15255456091

Sun Guangyu

Role: CONTACT

sunguangyu_vip@foxmail.com

+86 13956970687

Facility Contacts

Zhu Xiaoyu, Ph.D

Role: primary

xiaoyuz@ustc.edu.cn

+86 15255456091

Sun Guangyu

Role: backup

sunguangyu_vip@foxmail.com

+86 13956970687

Other Identifiers

QH10103-M-01（0）

Identifier Type: -

Identifier Source: org_study_id