Clin2
NCT04881240Possibly a fitRecruiting

Donor-made memory T-cell therapy for hard-to-treat leukemia

Acute Lymphoblastic Leukemia, in RelapseAcute Lymphoblastic Leukemia, RefractoryPediatric ALL

Treatments studied

Part of Blood & lymphatic, Cancer, Immune system & allergy clinical trials.

This Phase 1 study tests an immune-cell therapy made from a matched donor to treat relapsed or refractory CD19-positive leukemia. It may help patients who have limited options, especially those who cannot receive the standard donor-cell or self-made (autologous) CD19 CAR T-cell therapy.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
60 people
Ages
Up to 21 years
Study type
Interventional

Who can take part

  • You (the patient) are 21 years old or younger, and have CD19-positive leukemia confirmed by recent tests.
  • Your leukemia must have come back or not responded to previous treatments, and you meet the trial’s timing rules for relapse or refractory disease.
  • You must be in one of the study groups: Cohort A (you previously had a transplant using the selected donor) or Cohort B (you did not get that donor transplant).
  • If you are in Cohort B, you must not be a good candidate for self-made (autologous) CD19 CAR T-cell therapy for reasons like failed prior attempts or medical unsuitability for collection.
  • You must be well enough to tolerate treatment (including certain heart, lung, kidney, liver blood tests, and a minimum functional ability score).
  • You must not have serious active infections, certain brain/spinal cord involvement with leukemia symptoms, or recent major complications after a prior transplant (if you’ve had one).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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