A Study of CTD402 in T-ALL/LBL Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorBIOHENG THERAPEUTICS US LLC
About this trial
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.
Participants will receive one infusion of CTD402 on Day 0 and will be evaluated for anti-tumor activity by an independent review committee based on the NCCN criteria for T-ALL and the Lugano 2014 criteria for T-LBL.
Patients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.
Eligibility criteria
Qualifiers
Male or female, ≥ 12 years of age.
Participants with body weight ≥ 40 kilogram.
Relapsed or refractory disease after two or more lines of systemic therapy;
The first relapse occurs within 12 months after first remission;
Disqualifiers
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
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.
Trial design
Treatments tested in this trial
- CTD402 CAR T Cell Injection
Treatment groups
54 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov