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New treatment option for B-Cell Lymphoblastic Leukemia/Lymphoma
Official title CD19 & CD22 Bispecific CAR T Cells in the Treatment of Relapsed/Refractory B Cell Hematologic Tumors
ClinicalTrials.gov ID: NCT06735495
What this study is testing
What is CD19&CD22 bispecific CAR-T cells?
CD19&CD22 bispecific CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell lymphoblastic leukemia/lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multi-center, open, prospective single-arm clinical study of patients with relapsed / refractory B cell hematological tumors to evaluate the safety and efficacy of CD19 \& CD22 bispecific CAR-T cells in relapsed / refractory B cell hematological tumors while collecting pharmacokinetics and pharmacodynamics indicators of CAR-T cells.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 75
You may be able to join if
- 1.CD 19 + / CD 22 + B cell hematological tumor was confirmed by pathological and histological examination, and the patient met the following criteria...
- Refractory / relapsed B lymphocytic leukemia (1 of the following 4 items can be met): i . Recurrence within 6 months of first remission; ii. Primary...
- Refractory / relapsed B-cell lymphoma (meet the following item 1 of the first 4 items plus item 5): i . After four courses of chemotherapy with a...
- HGB≥70g/L(transfusible)
- Liver and kidney function: creatinine ≤1.5XULN: total bilirubin ≤1.5XULN:ALT and AST≤2.5X ULN
You likely can't join if
- ：(If meet any of the following criteria, patients will not be included)
- Serious heart insufficiency,LVEF \<50%
- History of severe pulmonary function impairment disease.
- Other malignant tumors in the advanced stage.
- Severe infection or persistent infection that cannot be effectively controlled.
- Combined with severe autoimmune disease or innate immune deficiency.
See the full eligibility criteria
- 1.CD 19 + / CD 22 + B cell hematological tumor was confirmed by pathological and histological examination, and the patient met the following criteria for relapsed or refractory B cell hematological tumor:
- Refractory / relapsed B lymphocytic leukemia (1 of the following 4 items can be met): i . Recurrence within 6 months of first remission; ii. Primary refractory without complete remission after 2 cycles of standard...
- Refractory / relapsed B-cell lymphoma (meet the following item 1 of the first 4 items plus item 5): i . After four courses of chemotherapy with a standard regimen, tumor shrinkage was less than 50% or disease...
- HGB≥70g/L(transfusible)
- Liver and kidney function: creatinine ≤1.5XULN: total bilirubin ≤1.5XULN:ALT and AST≤2.5X ULN
- Cardiopulmonary function: left ventricular ejection fraction \>50%; Blood oxygen saturation \>90%; 5.people with the Eastern Cooperative Oncology Group (ECOG) fitness scores of 0 to 2.
- ：(If meet any of the following criteria, patients will not be included)
- Serious heart insufficiency,LVEF \<50%
- History of severe pulmonary function impairment disease.
- Other malignant tumors in the advanced stage.
- Severe infection or persistent infection that cannot be effectively controlled.
- Combined with severe autoimmune disease or innate immune deficiency.
- Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA 500 IU / ml and abnormal liver function] or hepatitis C antibody [HCV-Ab] positive, HCV-RNA above the lower limit of detection of the analytical method...
- Human immunodeficiency virus (HIV) infection or syphilis infection.
- History of severe allergies to biological products (including antibiotics).
- Acute graft-versus-host response (GVHD) allogeneic hematopoietic stem remained one month after immunosuppressant discontinuation.
- Patients who have other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the clinical trial or interfere with the study results, and who are deemed...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.