Double-Barreled CAR t attack shows promise for tough childhood leukemia
NCT ID NCT05674175
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests a new approach for children and young adults with B-cell acute lymphoblastic leukemia (B-ALL) that has come back or not responded to treatment. It combines two types of engineered immune cells (CAR T cells) that target different markers on cancer cells (CD19 and CD22). The goal is to see if this dual attack is safe and effective, especially for patients who have already tried other cell therapies. About 93 participants will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two types of engineered immune cells: anti-CD22 CAR T cells and anti-CD19 CAR T cells
- What this could lead to
- If successful, this could offer a more effective treatment option for children with hard-to-treat B-ALL, potentially leading to longer remissions.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with a small number of participants. CAR T cell therapy can cause severe side effects like cytokine release syndrome. It may not work for everyone, and long-term effects are unknown.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 93 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Jul 2029
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 29 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.
Show the full entry requirements Hide 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: 1. Signed informed consent form 2. Patients with documented CD19+ and/or CD22+ ALL/LLy: 1. Cohort A: Patients with relapsed or refractory ALL/LLy: 2. Cohort B: Patients with poor response to prior B cell directed engineered cell therapy 3. Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy 4. Documentation of CD19 and/or CD22 tumor expression in bone marrow, peripheral blood, Cerebrospinal fluid, or tumor tissue by flow cytometry at the time of last detectable disease. If the patient has experienced a relapse after CD19-directed and/or CD22-directed therapy, flow cytometry should be evaluated after this therapy to demonstrate CD19 and/or CD22 expression. 5. Age 0-29 years 6. Adequate organ function 7. Adequate performance status defined as Lanksy or Karnofsky performance score ≥50. 8. Subjects of reproductive potential must agree to use acceptable birth control methods. Exclusion Criteria: 1. Active hepatitis B or active hepatitis C 2. HIV infection 3. Active acute or chronic Graft Vs. Host Disease requiring systemic therapy 4. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well. 5. Central nervous system disease that is progressive on therapy, or with Central nervous system parenchymal lesions that might increase the risk of central nervous system toxicity. 6. Pregnant or nursing (lactating) women 7. Uncontrolled active infection
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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.
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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
Locations
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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- Fighting fat to fight leukemia: could a diet and exercise plan boost chemo?
- Can a new combo drug tame childhood leukemia that Won't quit?
- Can donor immune cells be engineered to fight blood cancer?
- Can a Chemo-Antibody combo beat a tough leukemia?