The Clinical Application of Chimeric Antigen Receptor T Cells in the Treatment of CD19 Positive R… (NCT04184414) | Clinical Trial Compass
UnknownEarly Phase 1
The Clinical Application of Chimeric Antigen Receptor T Cells in the Treatment of CD19 Positive Recurrent Refractory B Cell-derived Hematological Malignancies
China10 participantsStarted 2018-01-09
Plain-language summary
CD19 is expressed in most B malignant tumors, especially in the former B cells ALL. This makes CD19 a natural target of immunotherapy. In terms of safety, the lack of B cells caused by CD19 targeted therapy will not cause life-threatening side effects (of course, Ig supplementation is necessary in the long-term B cell inhibition therapy). Moreover, the number of B cells can be restored after removing anti-CD19 treatment measures (such as anti-CD19 CART cells). In addition, CD19 has been chosen as the target of B-ALL therapy for the following reasons: â‘ as the BCR signal "amplifier", CD19 plays a role in PAX-5-mediated tumor formation; â‘¡ by activating MYC (as the oncogene controlled by PAX-5, C-MYC plays a key role in promoting the malignant proliferation of B cells), CD19 can cause B-ALL formation. Based on the above reasons, CD19 has become an ideal target in the treatment of B-cell cancer.
Who can participate
Age range18 Years – 70 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:
* 1\. At the time of initial diagnosis, the age is 18-70 years old, regardless of gender or race
* 2\. Morphological analysis showed that the load of lymphoma was ≥ 5%
* 3\. Estimated survival time \> 12 weeks
* 4\. The main investigator and the attending physician of the patient think that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation
* 5\. Relapsed / refractory B-cell acute lymphocytic leukemia (all): A. objective remission rate (or) of grade 2 or higher bone marrow recurrence B. bone marrow relapse after allogeneic stem cell transplantation (SCT), SCT treatment is more than 6 months and in or state before cart-19 reinfusion C. refractory patients (CR status is not reached after 2 rounds of standard chemotherapy (CR refers to the load of myeloma detected by morphology \< 5%)) D. Philadelphia chromosome positive (Ph +) and tyrosine kinase inhibitor (TKI) treatment failed twice or TKI failed to maintain or E. treatment with allogeneic SCT
* 6\. For patients with relapse, CD19 was detected in bone marrow or peripheral blood by flow cytometry within 3 months before admission
* 7\. CD19 expression on lymphoma cells: immunohistochemistry \> 15% or flow cytometry \> 30%
* 8\. The main organ functions are sound, including: A. renal function: radioisotope glomerular filtration rate \> 60 ml / min / 1.73 m2, or serum creatinine clearance rate in line with relevant age / gender standards B. alanine …
What they're measuring
1
CR
Timeframe: 12 weeks after infusion of the study drug