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

StatusRecruiting
PhasePhase 2
Started

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Record History

The 50 most recent of 107 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Jan 31, 2031 to Jan 31, 2032
  2. Re-verified, no change to tracked fields
  3. New version filed on ClinicalTrials.gov
  4. Re-verified, no change to tracked fieldsv104
  5. Start date changed from estimate of Jun 23, 2026 to Jun 16, 2026v103
Show 27 earlier versionsHide 27 earlier versions
  1. Start date: Jun 22, 2026 to Jun 23, 2026v102
  2. Start date: Jun 21, 2026 to Jun 22, 2026v101
  3. Start date: Jun 18, 2026 to Jun 21, 2026v100
  4. Start date: Jun 17, 2026 to Jun 18, 2026v99
  5. Start date: Jun 16, 2026 to Jun 17, 2026v98
  6. Start date: Jun 15, 2026 to Jun 16, 2026v97
  7. Start date: Jun 14, 2026 to Jun 15, 2026v96
  8. Start date: Jun 11, 2026 to Jun 14, 2026v95
  9. Start date: Jun 10, 2026 to Jun 11, 2026v94
  10. Start date: Jun 9, 2026 to Jun 10, 2026v93
  11. Start date: Jun 8, 2026 to Jun 9, 2026v92
  12. Start date: Jun 7, 2026 to Jun 8, 2026v91
  13. Start date: Jun 4, 2026 to Jun 7, 2026v90
  14. Start date: Jun 3, 2026 to Jun 4, 2026v89
  15. Start date: Jun 2, 2026 to Jun 3, 2026v88
  16. Start date: Jun 1, 2026 to Jun 2, 2026v87
  17. Start date: May 28, 2026 to Jun 1, 2026v86
  18. Start date: May 27, 2026 to May 28, 2026v85
  19. Start date: May 26, 2026 to May 27, 2026v84
  20. Start date: May 25, 2026 to May 26, 2026v83
  21. Start date: May 24, 2026 to May 25, 2026v82
  22. Start date: May 21, 2026 to May 24, 2026v81
  23. Start date: May 20, 2026 to May 21, 2026v80
  24. Start date: May 19, 2026 to May 20, 2026v79
  25. Start date: May 18, 2026 to May 19, 2026v78
  26. Start date: May 17, 2026 to May 18, 2026v77
  27. Start date: May 14, 2026 to May 17, 2026v76
  1. Recruitment opened
    • Start date: May 13, 2026 to May 14, 2026
    v75
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 12, 2026 to May 13, 2026
    v74
  3. Start date: May 11, 2026 to May 12, 2026v73
  4. Start date: May 10, 2026 to May 11, 2026v72
  5. Start date: May 7, 2026 to May 10, 2026v71
  6. Start date: May 6, 2026 to May 7, 2026v70
  7. Start date: May 5, 2026 to May 6, 2026v69
  8. Start date: May 4, 2026 to May 5, 2026v68
  9. Start date: May 3, 2026 to May 4, 2026v67
  10. Start date: Apr 30, 2026 to May 3, 2026v66
  11. Start date: Apr 29, 2026 to Apr 30, 2026v65
  12. Start date: Apr 28, 2026 to Apr 29, 2026v64
  13. Start date: Apr 27, 2026 to Apr 28, 2026v63
  14. Start date: Apr 26, 2026 to Apr 27, 2026v62
  15. Start date: Apr 23, 2026 to Apr 26, 2026v61
  16. Start date: Apr 22, 2026 to Apr 23, 2026v60
  17. Start date: Apr 21, 2026 to Apr 22, 2026v59
  18. Start date: Apr 20, 2026 to Apr 21, 2026v58
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07328503
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Acute Lymphoblastic Leukemia, B-All
Related terms Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov