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New treatment option for Lymphoblastic Leukemia
Official title Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma
ClinicalTrials.gov ID: NCT06961669
What this study is testing
What is Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis?
Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoblastic leukemia.
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 is an open label, single-site, dose-escalation study in up to 18 participants with Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 and older
You may be able to join if
- The patient or his/her guardian is fully informed and agrees to participate in this clinical study and signs the informed consent form;
- At the time of signing the informed consent form, be over 3 years of age, regardless of gender;
- Patients with a confirmed diagnosis of acute B-cell leukemia/B-cell lymphoma/multiple myeloma who meet one of the following criteria:
- B diffuse large B-cell lymphoma (DLBCL), germinal center, or activated B-cell type; Primary cutaneous DLBCL; Primary mediastinal (thymic) large...
- Patients diagnosed with acute B-cell leukemia: Patients who have achieved relapse after achieving remission after prior chemotherapy; or patients who...
You likely can't join if
- Episodes of central nervous system disease or presence of pathological changes within 6 months prior to screening, including but not limited to...
- patients with B-ALL with confirmed diagnosis of isolated extramedullary recurrence;
- presence of malignancies other than acute B-cell leukemia/B-cell lymphoma;
- Received the following anti-tumor therapies before cell collection: chemotherapy, targeted therapy, and other drug therapy within 14 days or at least...
- Vaccination, B-cell targeted therapy within 4 weeks prior to screening;
- Patient has systemic autoimmune disease or immunodeficiency;
See the full eligibility criteria
- The patient or his/her guardian is fully informed and agrees to participate in this clinical study and signs the informed consent form;
- At the time of signing the informed consent form, be over 3 years of age, regardless of gender;
- Patients with a confirmed diagnosis of acute B-cell leukemia/B-cell lymphoma/multiple myeloma who meet one of the following criteria:
- B diffuse large B-cell lymphoma (DLBCL), germinal center, or activated B-cell type; Primary cutaneous DLBCL; Primary mediastinal (thymic) large B-cell lymphoma; ALK anaplastic large B-cell lymphoma; High-grade B-cell...
- Patients diagnosed with acute B-cell leukemia: Patients who have achieved relapse after achieving remission after prior chemotherapy; or patients who have failed to achieve remission (\<5% bone marrow blasts or...
- Multiple Myeloma: Patients with confirmed diagnosis of multiple myeloma and patients with relapsed or refractory multiple myeloma according to IMWG 2016 diagnostic criteria.
- For patients with B-cell lymphoma, according to the recommendations for initial evaluation, staging, and response evaluation of Hodgkin and non-Hodgkin lymphoma (2014 edition), at least one measurable lesion in the...
- For patients with B-ALL, the proportion of bone marrow primitive and naïve lymphocytes in the screening period ≥5%;
- CD19 expression of tumor cells confirmed by flow cytometry or immunohistochemistry: the proportion of CD19 cells detected by peripheral blood flow cytometry in patients with B-ALL was ≥30%, and the proportion of CD19...
- Adequate function of vital organs: liver function satisfies ALT≤3×ULN, AST≤3×ULN; serum creatinine≤140μmol/L; Total bilirubin ≤ 2× ULN, and total bilirubin ≤ 3.0× ULN for patients with Gilbert syndrome; Haemodynamically...
- ECOG score: 0\~2 points;
- As judged by the investigator, the patient has an expected survival of more than 3 months;
- people of childbearing potential agree to use a reliable and effective method of contraception (excluding contraception during the safe period) for 2 years from the time of signing the informed consent form until...
- Episodes of central nervous system disease or presence of pathological changes within 6 months prior to screening, including but not limited to: stroke, stroke, aneurysm, epilepsy, convulsions, aphasia, severe head...
- patients with B-ALL with confirmed diagnosis of isolated extramedullary recurrence;
- presence of malignancies other than acute B-cell leukemia/B-cell lymphoma;
- Received the following anti-tumor therapies before cell collection: chemotherapy, targeted therapy, and other drug therapy within 14 days or at least 5 half-lives; Radiotherapy within 14 days;
- Vaccination, B-cell targeted therapy within 4 weeks prior to screening;
- Patient has systemic autoimmune disease or immunodeficiency;
- Grade 2\~4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks prior to screening;
- Patients with relatively serious heart disease, such as angina, myocardial infarction, heart failure and arrhythmia;
- History of severe allergy to drugs used in clinical studies or raw and excipient materials of experimental drugs, such as cyclophosphamide, fludarabine, DMSO, etc.;
- Patient has active hepatitis B, or positive HCV antibody, or HIV antibody, or syphilis;
- Presence of active infection requiring intravenous antibiotics or hospitalization;
- Pregnant or lactating women;
- Other investigators believe that the subject is not suitable to participate in this clinical study because it will affect the safety and how well it works judgment of the subject, or for other reasons;
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, 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.