RecruitingPhase 2

CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

United States20 participantsStarted 2026-05-13

Plain-language summary

Background: Acute lymphoblastic leukemia (ALL) is a type of blood cancer. Chimeric antigen receptor (CAR) therapy involves taking immune cells (T cells) from a person and modifying them to better target cancer cells. CAR T-cell therapy that targets a marker called CD19 has been show to can cure ALL in many children and adults. But in about 50% of patients, the ALL comes back within a year. Researchers want to find out if a second treatment with CAR T-cell therapy that targets a different marker, CD22, can keep the cancer away longer. Objective: To see if CD22 CAR T-cell therapy can keep ALL away longer. Eligibility: People aged 3 to 65 years who have no signs of cancer after CD19 CAR T-cell treatment for ALL. Design: Participants will be screened. They will have imaging scans and tests of their heart function. A sample of tissue (biopsy) will be collected from their bone marrow. They will have a fluid sample collected from the area around their spinal cord. Participants will undergo collection of their white blood cells (T cells) during a procedure called leukapheresis. Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. The cells will be altered in a lab to create CD22 CAR T-cell therapy. Participants will take drugs over 4 consecutive days to prepare their body for the CAR T-cell therapy; then they will receive their modified T cells through a tube inserted into a vein. Some people may need to stay in the hospital during treatment. Participants will have follow-up visits for 2 years.

Who can participate

Age range3 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Participants must have documentation of pathologic confirmation of a diagnosis of relapsed/refractory B cell acute lymphoblastic leukemia (ALL). * History of CD19 and CD22 expression on malignant cells at diagnosis or relapse. * Age between \>= 3 years and \<= 65 years * Participants must have received an FDA-approved CD19 CAR T-cell construct for treatment of B cell ALL within the time period of \>= 2 months and \<= 7 months prior to apheresis or lymphodepleting (LD) (if apheresis is not done on this protocol). * Must be in an MRD-negative remission as demonstrated by flow cytometry at screening. * Must be ineligible for or unwilling to undergo allogeneic stem cell transplant (SCT). * Clinical performance status (PS): Karnofsky \>= 50% (participants \>= 16 years of age), or Lansky scale \>= 50% (participants \< 16 years of age). Participants who are unable to walk because of paralysis, but who are upright in a wheelchair may be considered eligible. * Must have no ongoing signs of CRS from prior CAR T cell infusion and/or ICANs at screening. * Participants must have adequate organ function as defined below: * Total bilirubin \<= 2 x institutional upper limit of normal (ULN) * Aspartate Aminotransferase (AST) \<= 10 x ULN * Alanine Aminotransferase (ALT) \<= 10 x ULN * creatinine \<= the maximum for age listed below OR measured creatinine clearance \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above the max * Age: \<=5, Maxi…

What they're measuring

1-year RFS (recurrence free survival)

Timeframe: 1 year post cell infusion

Trial details

NCT IDNCT07328503

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2030-01-31

Contact for this trial

NCI Pediatric Leukemia, Lymphoma Transpl

(240) 760-6970 ncilltct@mail.nih.gov