Treatment using allogeneic γ9δ2 T cells for recurrent blood cancers

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

This study is testing if injections of special immune cells can help people with recurring blood cancers feel better after they’ve had a stem cell transplant.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 12 Years to 65 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Drugs / interventions: radiation
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT05755854 on ClinicalTrials.gov

What this trial studies

This open-label clinical study aims to evaluate the safety and tolerance of allogeneic γ9δ2 T cell injections in patients with recurrent hematologic tumors following allogeneic hematopoietic stem cell transplantation. The study will assess the in vivo dynamics of these T cells and explore the appropriate therapeutic dose. Participants will receive a combination of allogeneic γ9δ2 T cells along with Fludarabine, Cyclophosphamide, and Zoredronic acid as part of their treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12-65 with recurrent hematologic tumors after undergoing allogeneic hematopoietic stem cell transplantation.

Not a fit: Patients with simple extramedullary recurrence or those with significant organ failure may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent hematologic tumors, potentially improving their outcomes.

How similar studies have performed: While this approach is innovative, similar studies using T cell therapies have shown promise in treating hematologic malignancies.

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.

Where this trial is running

Hefei, Anhui

• Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)

Study contacts

• Principal investigator: Zhu Xiaoyu, Ph.D — Director of Hematology Department, Anhui Provincial Hospital
• Study coordinator: Zhu Xiaoyu, Ph.D

Conditions Hematologic Diseases; Recurrent hematologic tumors; Allogenic γδT Cell