Image

Allogeneic γ9δ2 T Cells Treatment of Recurrent Hematologic Tumors

Allogeneic γ9δ2 T Cells Treatment of Recurrent Hematologic Tumors

Recruiting
12-65 years
All
Phase 1

Powered by AI

Overview

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.

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

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.

Study details
    Hematologic Diseases

NCT05755854

Anhui Provincial Hospital

25 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.