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Engineered immune cells take on childhood blood cancers in early trial

NCT ID NCT06326463

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase trial tests a new type of immune therapy called CD70-CAR T cells in children and young adults up to age 21 with blood cancers that have come back or not responded to treatment. The therapy involves taking the patient's own immune cells, engineering them to recognize and attack cancer cells, and giving them back after a short course of chemotherapy. The main goal is to find the safest dose and see if the cells can fight the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CD70-CAR T cells (a type of immune cell therapy)
What this could lead to
If it works, this could offer a new treatment option for children with blood cancers that have not responded to standard therapy.
What could go wrong
This is a very early Phase 1 trial with only 18 participants, so it is not yet known if the therapy is effective. There may be serious side effects from the chemotherapy or the CAR T-cells.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

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

Started

Oct 2024

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Up to 21 years

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.

Inclusion Criteria Age ≤21 years old Relapsed/refractory CD70+ hematological malignancy Relapsed disease: Patients developing recurrent disease after a prior complete remission (CR) Refractory disease: Patients with persistent disease despite 3 cycles of induction chemotherapy. * Relapsed/refractory CD70+ AML or MDS: * Relapsed disease that is CD70 positive * Refractory disease that is persistent despite 3 cycles of chemotherapy * Relapsed/refractory CD70+ B-cell ALL: * Relapsed disease that is CD70 positive and CD19 negative/dim or patients otherwise ineligible for CD19-directed therapies including: * Patients in 2nd or greater relapse * Patients with relapse after allogeneic HSCT * Relapsed/refractory CD70+ T-cell ALL: * Relapsed /refractory disease that is CD70 positive * Mixed Phenotype Acute Leukemia (MPAL): * Relapsed/refractory that is CD70 positive * Relapsed/refractory CD70+ lymphoma: * Relapsed disease that is CD70 positive and CD19 negative/dim or patients otherwise ineligible for CD19-directed therapies including: * Patients in 2nd or greater relapse * Patients with relapse after allogeneic HSCT Estimated life expectancy of \>12 weeks Karnofsky or Lansky (age- dependent) performance score ≥50 Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis Patient must have an identified HCT donor For females of childbearing age: i. Not lactating with intent to breastfeed ii. Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment Exclusion Criteria * Known primary immunodeficiency * Known history of HIV positivity * Severe intercurrent bacterial, viral or fungal infection * History of hypersensitivity to cornstarch or hydroxyethyl starch * Patients with acute promyelocytic leukemia (APL) * Known contraindication to protocol defined lymphodepleting * chemotherapy regimen of Fludarabine/cyclophosphamide

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    1 site. 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

  • St. Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

    Contact Email: •••••@•••••

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