Acute Lymphocytic Leukemia RefractoryPhase 1/2TENACITY-01NCT07070219
A Study of CTD402 in T-ALL/LBL Patients
A Phase 1/2 study testing CTD402 CAR T Cell Injection in people with Acute Lymphocytic Leukemia Refractory and Lymphoma, Lymphoblastic, run by Imviva Bio at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Acute Lymphocytic Leukemia Refractory, Lymphoma, Lymphoblastic
- What is being tested?
- CTD402 CAR T Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 7 Oct 2025to 30 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, ≥ 1 year of age.
- Participants with body weight ≥ 40 kilogram.
- A) Relapsed or refractory T-ALL/LBL or MRD positive defined as one of the following:
- 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.
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- Minimal Residual Disease (MRD) positive T-ALL/LBL is defined as evidence of MRD, defined as < 5% blasts in bone marrow but ≥ 1 cancer cell in 1,000 cells determined by NGS ClonoSEQ® and/or other regionally acceptable methodologies (e.g., EuroMRD guidelines).
- The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
- Adequate organ function
- ECOG of 2 or less or Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants < 16) at screening.
Who cannot join
- 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
- Participants with following cardiac conditions will be excluded:
- 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.
- Primary immune deficiency.
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- Presence of uncontrolled infections.
- Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.
- Active or latent hepatitis B virus infection
- Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States8 sites, 7 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
- Withdrawn
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Nitin Jain, MD, njain@mdanderson.org
- Recruiting
Sarah Cannon Research Insitute
Nashville, Tennessee, 37203
Haydar Frangoul, MD, 844-482-4812
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 11101
Mark Geyer, MD
- Recruiting
Stanford University
Palo Alto, California, 94304
Lori Muffly, MD, scicto-trialposting@stanford.edu
- Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
- Recruiting
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10467
Alex Sica, MD
Australia1 site, 1 recruiting
- Recruiting
Royal Prince Alfred
Sydney, New South Wales
Ed Abadir, MD
About this study
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)
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.
Read the detailed description
TENACITY-01 is a single-arm, open-label, multi-center, Phase 1b/2 study to assess the safety and efficacy of CTD402 in pediatric and adolescents (≥ 1 to 17 years) and adult participants (≥ 18 years) with relapsed/refractory (r/r) T-ALL/LBL or T-ALL/LBL patients in remission but with MRD. The Phase 1b portion of the study will enroll up to 18 participants to evaluate the safety and establish the RP2D of CTD402 in both cohorts independently, which may be different. Up to 100 participants will be enrolled in the Phase 2 portion of the study to further confirm the efficacy and safety of CTD402; 36 participants will be enrolled in the R/R cohort and 66 participants will be enrolled in the MRD positive cohort.
Both the phase 1b and phase 2 portions will consist of the following sequential phases: screening (up to 2 weeks), lymphodepletion period (within 7 days prior to treatment), CTD402 treatment (a single dose), primary follow-up period (up to 2 years). Once a participant receives the first dose of lymphodepleting chemotherapy regimen, the participant will be considered enrolled into the study.
Long term follow-up will be conducted under a separate protocol until 15 years following CTD402 infusion for survival, toxicity, RCR monitoring, and secondary malignancy.
- Being tested
- CTD402 CAR T Cell Injection
- Keywords
- CAR-T Therapy, relapsed/refractory
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTD402 CAR T Cell InjectionDrug
CAR T cells
| Study group | Role | What they receive |
|---|---|---|
| R/R T-ALL/LBL | Experimental | Not described Receives: Drug: CTD402 CAR T Cell Injection |
| T-ALL/LBL in remission but with minimal residual disease | Experimental | Not described Receives: Drug: CTD402 CAR T Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile
Incidence of dose limiting toxicities including incidence of adverse events and graft vs host disease
Measured: 24 months
Response Evaluation
Percentage of participants who achieve overall complete remission (OCR) assess by an independent review committee
Measured: 24 months
Secondary outcomes (1)
Characterize the cPK profile of CTD402
CTD402 cellular pharmacokinetic (PK)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start7 Oct 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic Leukemia RefractoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imviva Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070219
- Sponsor's protocol ID
- BHCT-CTD402-201
- Acronym
- TENACITY-01
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07070219
- Acronym / sponsor ID
- TENACITY-01 / BHCT-CTD402-201
- Keywords
- CAR-T Therapy, relapsed/refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Imviva BioIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TENACITY-01 is a single-arm, open-label, multi-center, Phase 1b/2 study to assess the safety and efficacy of CTD402 in pediatric and adolescents (≥ 1 to 17 years) and adult participants (≥ 18 years) with relapsed/refractory (r/r) T-ALL/LBL or T-ALL/LBL patients in remission but with MRD. The Phase 1b portion of the study will enroll up to 18 participants to evaluate the safety and establish the RP2D of CTD402 in both cohorts independently, which may be different. Up to 100 participants will be enrolled in the Phase 2 portion of the study to further confirm the efficacy and safety of CTD402; 36 participants will be enrolled in the R/R cohort and 66 participants will be enrolled in the MRD positive cohort.
Both the phase 1b and phase 2 portions will consist of the following sequential phases: screening (up to 2 weeks), lymphodepletion period (within 7 days prior to treatment), CTD402 treatment (a single dose), primary follow-up period (up to 2 years). Once a participant receives the first dose of lymphodepleting chemotherapy regimen, the participant will be considered enrolled into the study.
Long term follow-up will be conducted under a separate protocol until 15 years following CTD402 infusion for survival, toxicity, RCR monitoring, and secondary malignancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R/R T-ALL/LBL | Experimental | Drug: CTD402 CAR T Cell Injection |
| T-ALL/LBL in remission but with minimal residual disease | Experimental | Drug: CTD402 CAR T Cell Injection |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, ≥ 1 year of age.
- Participants with body weight ≥ 40 kilogram.
- A) Relapsed or refractory T-ALL/LBL or MRD positive defined as one of the following:
- The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
- Adequate organ function
Key exclusion criteria (10 listed)
- 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
- Participants with following cardiac conditions will be excluded:
- Primary immune deficiency.
- Presence of uncontrolled infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTD402 CAR T Cell InjectionCAR T cells | Drug | R/R T-ALL/LBL, T-ALL/LBL in remission but with minimal residual disease |
Primary outcome
Safety Profile
Time frame: 24 months
Incidence of dose limiting toxicities including incidence of adverse events and graft vs host disease
Response Evaluation
Time frame: 24 months
Percentage of participants who achieve overall complete remission (OCR) assess by an independent review committee
1 secondary outcome
Characterize the cPK profile of CTD402
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CTD402 CAR T Cell Injection in people with Acute Lymphocytic Leukemia Refractory and Lymphoma, Lymphoblastic, run by Imviva Bio at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Davidson-Moncada, MD, PhD (917-573-8538, clinicaltrials@imvivabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Profile (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.