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Tests treatment safety and results for Immune Effector Cell Associated Hematotoxicity
Official title Safety and Efficacy of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in the Treatment of Long-Term Cytopenia After CAR-T Therapy
ClinicalTrials.gov ID: NCT07212335
What this study is testing
What is Mesenchymal Stem Cell Infusion?
Mesenchymal Stem Cell Infusion is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for immune effector cell associated hematotoxicity.
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 single arm, open label, exploratory clinical study aimed at evaluating the efficacy, and safety of allogeneic umbilical cord blood-derived mesenchymal stem cells in the treatment of long-term cytopenia after CAR-T therapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet all the following criteria to be enrolled in this study:
- 1.Voluntarily participate in the study and sign the informed consent form;
- 2.Aged ≥ 18 years, regardless of gender;
- 3.Patients with acute lymphoblastic leukemia (ALL), lymphoma, or myeloma who still have severe cytopenia (meeting any of the following conditions...
- 4.ECOG performance status score ≤ 2;
You likely can't join if
- Patients with any of the following conditions are prohibited from enrolling in this study:
- 1.Having received other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, or...
- 2.Significant bone marrow infiltration by tumor cells during the screening period (for ALL: bone marrow morphological examination showing leukemia...
- 3.Presence of any of the following conditions within 1 week before the first dose administration: infection with hemodynamic instability (requiring...
- 4.Serum creatinine or blood urea nitrogen ≥ 1.5 times the upper limit of normal (ULN);
- 5.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times ULN; total bilirubin ≥ 1.5 times ULN;
See the full eligibility criteria
- Patients must meet all the following criteria to be enrolled in this study:
- 1.Voluntarily participate in the study and sign the informed consent form;
- 2.Aged ≥ 18 years, regardless of gender;
- 3.Patients with acute lymphoblastic leukemia (ALL), lymphoma, or myeloma who still have severe cytopenia (meeting any of the following conditions: absolute neutrophil count ≤ 1×10⁹/L; platelet count ≤ 30×10⁹/L...
- 4.ECOG performance status score ≤ 2;
- 5.Estimated survival time ≥ 6 months;
- 6.For female patients of childbearing potential, a negative pregnancy test result is required. Female patients of childbearing potential and male patients must use highly effective contraceptive measures during the...
- Patients with any of the following conditions are prohibited from enrolling in this study:
- 1.Having received other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, or hematopoietic stem cell transplantation) that may affect the hematopoietic...
- 2.Significant bone marrow infiltration by tumor cells during the screening period (for ALL: bone marrow morphological examination showing leukemia cell proportion \> 5%; for multiple myeloma (MM) and lymphoma: bone...
- 3.Presence of any of the following conditions within 1 week before the first dose administration: infection with hemodynamic instability (requiring vasoactive drug support); deep fungal infection confirmed by imaging or...
- 4.Serum creatinine or blood urea nitrogen ≥ 1.5 times the upper limit of normal (ULN);
- 5.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times ULN; total bilirubin ≥ 1.5 times ULN;
- 6.Other severe and/or uncontrolled diseases, or conditions that may affect study participation as judged by the investigator, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g...
- 7.History of arteriovenous thrombosis or atherosclerosis;
- 8.Positive for anti-human immunodeficiency virus (HIV) antibody or anti-Treponema pallidum specific antibody; positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody with hepatitis B...
- 9.A history of or current malignant solid tumor (except cured non-invasive basal cell or squamous cell carcinoma of the skin and/or other cured carcinoma in situ; except other malignant tumors that have achieved...
- 10.Within 6 months after allogeneic hematopoietic stem cell transplantation, or donor cell chimerism rate ≤ 95%, or presence of active acute graft-versus-host disease (aGVHD) of Grade Ⅱ or higher, or moderate to severe...
- 11.Having received a live vaccine within 4 weeks before the first dose administration, or planning to receive any live vaccine during the study period;
- 12.Pregnant or lactating female patients;
- 13.Patients with mental disorders;
- 14.Participation in any other study drug trial (including vaccine trials) or exposure to other study drugs within 4 weeks or 5 half-lives (whichever is longer) before the first dose administration;
- 15.Patients who refuse to sign the informed consent form;
- 16.Other conditions deemed unsuitable for study inclusion by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, 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.