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New treatment option for Acute Lymphocytic Leukemia Refractory
Official title A Study of CTD402 in T-ALL/LBL Patients
ClinicalTrials.gov ID: NCT07070219
What this study is testing
What is CTD402 CAR T Cell Injection?
CTD402 CAR T Cell Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphocytic leukemia refractory.
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
- The goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed/refractory T-ALL/LBL patients. Participants with relapsed/refractory T-ALL/LBL over the age of 12 will be eligible to participate.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Male or female, ≥ 12 years of age.
- Participants with body weight ≥ 40 kilogram.
- Relapsed or refractory T-ALL/LBL is defined as one of the following:
- Relapsed or refractory disease after two or more lines of systemic therapy;
- The first relapse occurs within 12 months after first remission;
You likely can't join if
- Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.
- Active central nervous system (CNS) involvement
- Participants with following cardiac conditions will be excluded:
- History of heart failure New York Heart Association (NYHA) class III or IV;
- History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of...
- Primary immune deficiency.
See the full eligibility criteria
- Male or female, ≥ 12 years of age.
- Participants with body weight ≥ 40 kilogram.
- Relapsed or refractory T-ALL/LBL is defined as one of the following:
- Relapsed or refractory disease after two or more lines of systemic therapy;
- The first relapse occurs within 12 months after first remission;
- Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.
- The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
- Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligible haploidentical donor (HID) or syngeneic donors.
- Adequate organ function
- Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening. Key
- Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.
- Active central nervous system (CNS) involvement
- Participants with following cardiac conditions will be excluded:
- History of heart failure New York Heart Association (NYHA) class III or IV;
- History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.
- Primary immune deficiency.
- Presence of uncontrolled infections.
- Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.
- Active or latent hepatitis B virus infection
- Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Denver, Colorado, United States
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- The Bronx, New York, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Denver, Colorado, United States; Chicago, Illinois, United States; Rochester, Minnesota, United States; New York, New York, United States; The Bronx, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.