New Dual-Target CAR t therapy hopes to beat childhood leukemia
NCT ID NCT06777979
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new type of immune cell therapy (CAR T cells) that targets two proteins, CD19 and CD22, on leukemia cells. It is for children and young adults up to age 21 whose leukemia has returned or not responded to standard treatments. The main goal is to find a safe dose and check for side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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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
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Up to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Collection and Manufacturing Eligibility Inclusion Criteria: * Age \<21 years old * Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as: \*CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy * Second or greater relapse * Any relapse after allogeneic HCT * Refractory disease (primary or in relapse) despite therapy designed to induce remission * Estimated life expectancy of \> 12 weeks * Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A) * For females of childbearing age: * Not lactating with intent to breastfeed * Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment Exclusion Criteria: * Known primary immunodeficiency * Known HIV positivity * Known contraindication to receiving protocol defined lymphodepleting * chemotherapy regimen * History of hypersensitivity reaction to murine protein-containing products Treatment Eligibility Inclusion Criteria: * Age \< 21 years old * Detectable disease in the bone marrow * Estimated life expectancy of \> 8 weeks * Karnofsky or Lansky (age-dependent) performance score \> 50 (Appendix A) * Adequate cardiac function defined as left ventricular ejection fraction \>40%, or shortening fraction \> 25% * EKG without evidence of clinically significant arrhythmia * Adequate renal function defined as creatinine clearance or radioisotope GFR \>50 mL/min/1.73m2 (GFR \>40 mL/min/1.73m2 if \<2 years of age) * Adequate pulmonary function defined as forced vital capacity (FVC) \>50% of predicted value; or pulse oximetry \>92% on room air * Total bilirubin \< 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 5 times the upper limit of normal for age * Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy * Prior to planned CAR T cell infusion, patients with a history of prior allogeneicHCT must be at least 3 months from HCT, have no evidence of acute GVHD, and have not received a donor lymphocyte infusion (DLI) within the 28 daysprior to planned infusion * For females of childbearing age: * Not lactating with intent to breastfeed * Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment * If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom. Exclusion Criteria: * Known primary immunodeficiency * Known HIV positivity * Known contraindication to receiving protocol defined lymphodepleting * chemotherapy regimen * History of hypersensitivity reactions to murine protein-containing products * Severe, uncontrolled bacterial, viral or fungal infection * Active CNS-3 disease * Evidence of active, uncontrolled neurologic disease
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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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St. Jude Children's Research Hospital
RECRUITINGMemphis, Tennessee, 38105, United States
Contact Email: •••••@•••••
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