A Study of CTD402 in T-ALL/LBL Patients

This study, called TENACITY-01, is testing a treatment called CTD402 CAR T Cell Injection for people with T-cell Acute Lymphocytic Leukemia (T-ALL) or Lymphoblastic Lymphoma (LBL) that has come back or not responded to previous treatments. The main goals are to see if CTD402 is safe and how well it works. You might be able to join if you are 12 years or older, weigh at least 40 kilograms, and have T-ALL/LBL that has relapsed or is refractory after two or more treatments, or if your first relapse happened within 12 months of your first remission. The study plans to enroll 54 participants and is currently unclear if it is recruiting.

Study design
This is a single-arm, open-label study, meaning all participants receive the same treatment and everyone knows what treatment is being given. It will enroll about 54 participants in two phases to assess the safety and effectiveness of CTD402.
What's involved
You would receive one infusion of CTD402 after a period of chemotherapy. You will be followed for up to 24 months in this study, and then for up to 15 years under a separate long-term follow-up protocol.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 months within this study, and then for up to 15 years under a separate long-term follow-up protocol to monitor survival, side effects, and other health outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07070219

A Study of CTD402 in T-ALL/LBL Patients

Recruiting
PHASE1Ages 1+InterventionalTreatment
Imviva Bio
~118 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:CTD402 CAR T Cell Injection

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety Profile
Measured over 24 months
+1 more outcome measured
Acute Lymphocytic Leukemia Refractory
Lymphoma, Lymphoblastic

NCT07070219

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • Sarah Cannon Research Insitute

    Nashville, Tennesseestudy coordinator listed

    Recruiting

  • Stanford University

    Palo Alto, Californiastudy coordinator listed

    Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesotano site contact published

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkno site contact published

    Recruiting

  • Montefiore Einstein Comprehensive Cancer Center

    The Bronx, New Yorkno site contact published

    Recruiting

  • Royal Prince Alfred

    Sydney, New South Wales, Australiano site contact published

    Recruiting

  • University of Chicago

    Chicago, Illinoisno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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.
  • Safety Profile24 months

    Incidence of dose limiting toxicities including incidence of adverse events and graft vs host disease

  • Response Evaluation24 months

    Percentage of participants who achieve overall complete remission (OCR) assess by an independent review committee