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New cell therapy offers hope for tough blood cancers

NCT ID NCT07070219

Disease control Sponsor: Imviva Bio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study tests a new treatment called CTD402 for people with T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LBL) that has come back or not responded to other treatments. Participants receive one infusion of CTD402 and are monitored for safety and how well it fights the cancer. The study includes people aged 12 and older and follows them for up to 2 years, with a separate long-term follow-up for up to 15 years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 118 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Male or female, ≥ 1 year of age. 2. Participants with body weight ≥ 40 kilogram. 3. 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. B) 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). 4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening. 5. Adequate organ function 6. ECOG of 2 or less or Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening. Key Exclusion Criteria: 1. Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome. 2. Active central nervous system (CNS) involvement 3. Participants with following cardiac conditions will be excluded: 1. History of heart failure New York Heart Association (NYHA) class III or IV; 2. History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment. 4. Primary immune deficiency. 5. Presence of uncontrolled infections. 6. Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis. 7. Active or latent hepatitis B virus infection 8. Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia lymphoblastic lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence refractory precursor T-lymphoblastic lymphoma/leukemia T-cell acute lymphoblastic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphocytic leukemia refractory Lymphoma, lymphoblastic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Colorado Blood Cancer Institute

    WITHDRAWN

    Denver, Colorado, 80218, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 11101, United States

  • Montefiore Einstein Comprehensive Cancer Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Royal Prince Alfred

    RECRUITING

    Sydney, New South Wales, Australia

  • Sarah Cannon Research Insitute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

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