New CAR T-Cell therapy targets tough blood cancers
NCT ID NCT07135466
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment called SHB-04-CD22, which uses a patient's own immune cells (T-cells) engineered to find and attack cancer cells that have a protein called CD22. It is for children and adults (ages 1-80) with B-cell cancers that have come back or not responded to at least two prior treatments. The goal is to check if the therapy is safe and can shrink or eliminate the cancer.
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 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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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1 year to 80 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.
Inclusion Criteria: * Patient must have a CD22-expressing hematologic malignancy, relapsed or refractory after receiving at least 2 lines of standard therapy including CD19-directed therapy (For CD19 positive disease): * Relapse following standard relapse protocol (2nd relapse), including CD19 CART. * Primary refractory, i.e. failed to achieve morphologic remission after 2 lines of induction chemotherapy. * Age 1-80 years * CD22 expression shown by flow cytometry on at least 70% of leukemic blasts / lymphoma cells * Adequate CD3 count (above 120 CD3+ cells per microliter blood) * Clinical performance status: Patients \> 10 years of age: Karnofsky ≥ 50%; Patients ≤ 10 years of age: Lansky scale ≥ 50%. Exception for neurologic symptoms (e.g. paralysis) that are explained by the malignancy. * Females of child-bearing potential must have a negative pregnancy test * Cardiac function: LV ejection fraction \>45% or shortening fraction \>28% * At least 60 days after autologous or allogeneic BMT * At least 30 days after prior CAR therapy in absence of response
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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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Sheba Medical Center
RECRUITINGRamat Gan, G, Israel
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Other studies related to the condition(s) this trial covers.
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- Can AI spot the lymphoma patients who Won't respond?
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