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NCT07070219 · ClinicalTrials.gov registry record · Phase 1
A Study of CTD402 in T-ALL/LBL Patients
A Phase 1 study of Acute Lymphocytic Leukemia Refractory and Lymphoma, Lymphoblastic, sponsored by Bioheng Therapeutics US.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 8
- Study locations
NCT07070219: Recruiting Phase 1 study of Acute Lymphocytic Leukemia Refractory and Lymphoma, Lymphoblastic, sponsored by Bioheng Therapeutics US.
NCT07070219 is a Phase 1 study of Acute Lymphocytic Leukemia Refractory and Lymphoma, Lymphoblastic that is actively recruiting participants, run by Bioheng Therapeutics US. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07070219, a Phase 1 study of Acute Lymphocytic Leukemia Refractory and Lymphoma, Lymphoblastic, is actively recruiting participants, sponsored by Bioheng Therapeutics US.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 8
- Study locations
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 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.
Primary Outcome
Incidence of dose limiting toxicities including incidence of adverse events and graft vs host disease
Conditions Studied
Interventions
- DRUG CTD402 CAR T Cell Injection
Study Locations (8)
New York
- Memorial Sloan Kettering Cancer Center - New York
- Montefiore Einstein Comprehensive Cancer Center - The Bronx
California
- Stanford University - Palo Alto
Colorado
- Colorado Blood Cancer Institute - Denver
Illinois
- University of Chicago - Chicago
Minnesota
- Mayo Clinic - Rochester - Rochester
Tennessee
- Sarah Cannon Research Insitute - Nashville
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2025-10-07 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 1 |
What NCT07070219 shows while recruiting
NCT07070219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 2 conditions, with Acute Lymphocytic Leukemia Refractory appearing as the primary indexed condition, and to 1 intervention - of which CTD402 CAR T Cell Injection is the first listed.
NCT07070219 lists 8 locations in 7 states (New York, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT07070219 about?
NCT07070219 is a clinical study titled "A Study of CTD402 in T-ALL/LBL Patients". 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...
What is the current status of trial NCT07070219?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2025-10-07. Estimated completion is 2028-12-30.
What conditions does trial NCT07070219 study?
This clinical trial studies the following conditions: Acute Lymphocytic Leukemia Refractory, Lymphoma, Lymphoblastic.
What interventions are being tested in trial NCT07070219?
The interventions under investigation include: CTD402 CAR T Cell Injection (DRUG).
Who is sponsoring clinical trial NCT07070219?
This trial is sponsored by Bioheng Therapeutics US, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07070219 being conducted?
This trial has 8 study locations across California, Colorado, Illinois, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07070219's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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