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Recruiting Phase 1Phase 2 Interventional

A Study of CTD402 in T-ALL/LBL Patients

ClinicalTrials.gov ID: NCT07070219

Public ClinicalTrials.gov record NCT07070219. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 14, 2026, 10:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Single-Arm, Open-Label, Multi-Center, Phase 1b/ 2 Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTD402 in Participants With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL) (TENACITY-01)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07070219
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Imviva Bio
Industry
Enrollment
118 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Year and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 6, 2025
Primary completion
Sep 29, 2028
Completion
Dec 29, 2028
Last update posted
Aug 18, 2026

2025 – 2028

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
Stanford University Palo Alto California 94304 Recruiting
Colorado Blood Cancer Institute Denver Colorado 80218 Withdrawn
University of Chicago Chicago Illinois 60637 Recruiting
Mayo Clinic - Rochester Rochester Minnesota 55905 Recruiting
Memorial Sloan Kettering Cancer Center New York New York 11101 Recruiting
Montefiore Einstein Comprehensive Cancer Center The Bronx New York 10467 Recruiting
Sarah Cannon Research Insitute Nashville Tennessee 37203 Recruiting
MD Anderson Cancer Center Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07070219, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 18, 2026 · Synced Sep 14, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07070219 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →