BridgeMD
New treatment option for T-Cell Acute Lymphocytic Leukemia
Official title CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-cell Malignancies
ClinicalTrials.gov ID: NCT06316856
What this study is testing
What is Autologous CD5 CAR T-cells?
Autologous CD5 CAR T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for t-cell acute lymphocytic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\^6 (±20%) to dose level 2: 2×10\^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 70
You may be able to join if
- Only patients who meet all the following criteria can be included:
- Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intolerant of...
- For people who received autologous CD5 CAR T cells, the tumor burden in peripheral blood is less than 20%, and suspending anti-neoplastic treatment...
- Aged 1-70 years;
- No severe allergy;
You likely can't join if
- Patients with at least one of the following conditions are excluded:
- Impaired consciousness or intracranial hypertension;
- Symptomatic congestive heart failure or severe cardiac arrhythmia;
- Manifestations of severe respiratory system failure;
- Co-existence with other malignancies;
- Disseminated intravascular coagulation;
See the full eligibility criteria
- Only patients who meet all the following criteria can be included:
- Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently available...
- For people who received autologous CD5 CAR T cells, the tumor burden in peripheral blood is less than 20%, and suspending anti-neoplastic treatment for more than 2 weeks;
- Aged 1-70 years;
- No severe allergy;
- Eastern Cooperative Oncology Group (ECOG) performance status 1 score 0 to 2;
- Patients are expected to live for at least 60 days;
- CD5+ on blasts in bone marrow (BM) or cerebrospinal fluid (CSF) and tumor tissues by flow cytometry and immunohistochemistry, respectively. (Positive rate \>80% by flow cytometry with less than one log difference in...
- Provide a signed informed consent before any screening procedure. people who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the...
- Have available allogeneic hematopoietic stem cell transplantation donor for the subject who received newly matched donor-derived CD5 CAR T cells, and is willing to perform SCT when CR is achieved.
- Patients with at least one of the following conditions are excluded:
- Impaired consciousness or intracranial hypertension;
- Symptomatic congestive heart failure or severe cardiac arrhythmia;
- Manifestations of severe respiratory system failure;
- Co-existence with other malignancies;
- Disseminated intravascular coagulation;
- Serum creatinine and/or blood urea nitrogen (BUN) ≥ 1.5-fold upper limit;
- Sepsis or other uncontrollable infections;
- Uncontrollable diabetes;
- Serious mental illness;
- Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI);
- Underwent organ transplantation, excepting SCT;
- Pregnant females;
- Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis;
- Post-CAR SCT is not feasible in patients who plan to receive newly matched donor-derived CD5 CAR T cells;
- Inability to collect peripheral blood mononuclear cells (PBMC) or no frozen PBMC available for CAR T cell manufacturing.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.