A Study of CTD402 in T-ALL/LBL Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
CTD402 CAR T Cell Injection: CAR T cells
Study summary
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 1 year 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
Primary outcome measure(s)
- Safety Profile — 24 months
Incidence of dose limiting toxicities including incidence of adverse events and graft vs host disease - Response Evaluation — 24 months
Percentage of participants who achieve overall complete remission (OCR) assess by an independent review committee
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Stanford University | Palo Alto | California | Recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | Withdrawn |
| University of Chicago | Chicago | Illinois | Recruiting |
| Mayo Clinic - Rochester | Rochester | Minnesota | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Montefiore Einstein Comprehensive Cancer Center | The Bronx | New York | Recruiting |
| Sarah Cannon Research Insitute | Nashville | Tennessee | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Royal Prince Alfred | Sydney | New South Wales | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07070219 on ClinicalTrials.gov ↗ ← All trials in the USA