Clinical trial NCT05755854: Allogeneic γ9δ2 T Cells Treatment of Recurrent Hematologic Tumors
Official title: Allogeneic γ9δ2 T Cells for the Treatment of Recurrent Hematologic Tumors After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hematologic Diseases
Keywords: Recurrent hematologic tumors
Allogenic γδT Cell
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-06
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: 12 months
measure: Incidence of Dose-Limiting Toxicities (DLTs)
timeFrame: First infusion date of allogeneic γ9δ2 T cells to 14 days end cell infusion
measure: Maximum tolerated dose (MTD)
timeFrame: 14 days
measure: Recommended phase 2 dose (RP2D)
timeFrame: 14 days
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 12 months
measure: Progression Free Survival (PFS)
timeFrame: 12 months
measure: Pharmacokinetics: Persistence of the allogeneic γ9δ2 T cells
timeFrame: 14 days
measure: Pharmacodynamics: Peak level of cytokines in serum
timeFrame: 14 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
Study officials:
affiliation: Director of Hematology Department, Anhui Provincial Hospital
name: Zhu Xiaoyu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: