Allogeneic γ9δ2 T Cells for the Treatment of Recurrent Hematologic Tumors After Allogeneic Hematopoietic Stem Cell Transplantation

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:

• 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;

• 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.

Locations
Other Locations
China
Anhui Provincial Hospital
RECRUITING
Hefei
Contact Information
Primary
Zhu Xiaoyu, Ph.D
xiaoyuz@ustc.edu.cn
+86 15255456091
Backup
Sun Guangyu
sunguangyu_vip@foxmail.com
+86 13956970687
Time Frame
Start Date: 2023-05-03
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 10
Treatments
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials