A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma (NCT04204161) | Clinical Trial Compass
UnknownPhase 1
A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma
China30 participantsStarted 2019-10-08
Plain-language summary
This is a single arm, open-label, uni-center, phase I study . In this study, Children withCD19+/CD22+ R/R B-cell acute lymphoblastic leukemia or lymphoma will be treated with CAR-T19/CAR-T22 Immunotherapy to determine the safety and efficacy of treatment.
Who can participate
Age range1 Month – 18 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
✓. no available curative treatment options (such as autologous or allogeneic SCT)
✓. If patients had receive immunotherapy, they should reach requirments:tumor recurrency or the number of B cells recovered.
✓. Patients with recurrence after hematopoietic stem cell transplantation need additional satisfaction: 1) no GvHD and not require immunosuppression;2) stem cell transplantation was completed for at least 4 months, and at least 6 months before the CART reinfusion;
✓. Patients must be willing to sign an informed consent.
✓. Age:≤18 years.
✓. survival\>12 weeks
✓. Flow cytometry or IHC showed positive expression of CD19/ CD22 in tumor cells within two months.
✕. organ failure:heart failure Ⅲ and Ⅳ;The liver reached grade C of child-turcotte .Renal failure and uremia;Respiratory failure;People with impaired consciousness.
✕. Acute or chronic GVHD after allogeneic hematopoiesis. Hormone or immunosuppressant was used within 30 days.
What they're measuring
1
Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0