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New treatment option for Acute Myeloid Leukemia (AML)
Official title uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
ClinicalTrials.gov ID: NCT07109518
What this study is testing
What is uCD7 CART?
uCD7 CART is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia (aml).
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
- The aim of this study was to evaluate the safety and efficacy of universal CD7 CART (uCD7 CART) cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase 1 clinical trial, two cohorts were set up: (1) relapsed and refractory acute myeloid leukemia (AML) cohort; and (2) relapsed and refractory T lymphoblastic leukemia/lymphoma (T-ALL/LBL) cohort.
- 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 to 70
You may be able to join if
- Age ≥18 and \<70 years, regardless of gender;
- T-ALL/LBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and T-cell Lymphoma...
- Patients diagnosed with AML with reference to the Guidelines for Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2018 Edition) issued by the...
- Cytology confirmed that the tumor cells were CD7 positive.
- Number of blasts in bone marrow ≥5% at screening (bone marrow morphology);
You likely can't join if
- people who met any of the following criteria were excluded from the study:
- acute promyelocytic leukemia (APL);
- Presence of a genetic syndrome such as Fanconi's anemia, Kostmann's syndrome, Shwachman syndrome or any other known syndrome of bone marrow failure;
- Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3;
- Patients who have received anti-tumor therapy before infusion should be excluded if any of the following conditions are met:
- Systemic chemotherapy (except for pretreatment) within 1 week;
See the full eligibility criteria
Who can join
- Age ≥18 and \<70 years, regardless of gender;
- T-ALL/LBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and T-cell Lymphoma Clinical Practice Guidelines (2020.v1);
- Patients diagnosed with AML with reference to the Guidelines for Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2018 Edition) issued by the Health Commission;
- Cytology confirmed that the tumor cells were CD7 positive.
- Number of blasts in bone marrow ≥5% at screening (bone marrow morphology);
- Complies with the diagnosis of relapsed/refractory AML, including any of the following conditions according to China Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2021 Edition):
- Primary refractory patients who did not achieve CR after two cycles of standard induction chemotherapy;
- CR after consolidation chemotherapy, relapse within 12 months;
- Relapse 12 months after remission but ineffective after conventional chemotherapy;
- 2 or more relapses;
- Relapse after hematopoietic stem cell transplantation.
- Meet the diagnosis of relapsed/refractory T-ALL/LBL, including any of the following:
- Primary refractory patients who have not achieved complete response after two cycles of standard chemotherapy, or patients who have not achieved complete response after multi-line rescue chemotherapy;
- Relapse within \<12 months after complete remission or ≥12 months after complete remission and fail to achieve complete remission induced by 1 or more cycles of standard treatment;
- Relapse after hematopoietic stem cell transplantation or relapse after CAR-T therapy at the same target;
- Complies with diagnosis of other relapsed/refractory CD7 positive hematologic malignancies
- Creatine clearance \>60ml/min (Cockcroft and Gault formula); serum total bilirubin ≤3 times the upper limit of normal, serum ALT and AST ≤5 times the upper limit of normal range for patients without liver invasion;
- Echocardiography showing left ventricular ejection fraction (LVEF) ≥50%;
- Pulse oxygen saturation ≥92%;
- The estimated survival time is more than 3 months;
- ECOG score 0-2;
- people or their legal guardians voluntarily participate in this trial and sign the informed consent form.
What rules you out
- people who met any of the following criteria were excluded from the study:
- acute promyelocytic leukemia (APL);
- Presence of a genetic syndrome such as Fanconi's anemia, Kostmann's syndrome, Shwachman syndrome or any other known syndrome of bone marrow failure;
- Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3;
- Patients who have received anti-tumor therapy before infusion should be excluded if any of the following conditions are met:
- Systemic chemotherapy (except for pretreatment) within 1 week;
- For those who have received monoclonal antibody therapy, the last time of monoclonal antibody infusion is less than 5 half-lives or 4 weeks (whichever is shorter) at screening;
- Received donor lymphocyte infusion (DLI) within 6 weeks;
- Presence of uncontrolled, serious, active infection at screening;
- Patients with a history of serious heart disease, including: severe cardiac insufficiency (people with cardiac insufficiency of Class III or IV according to the New York Heart Association (NYHA) cardiac function...
- Previous craniocerebral trauma, disturbance of consciousness, epilepsy, cerebral ischemia, cerebral vascular hemorrhagic disease and other medical history, and within six months of the need for drug treatment;
- Patients with hepatitis B surface antigen (HBsAg) greater than 10E6 IU/mL, hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis antibody test positive, EBER positive...
- Patients who must use steroid hormones during CAR-T infusion (except for local or inhaled steroid hormones); people who are receiving systemic steroid therapy before screening and need long-term systemic steroid therapy...
- people with autoimmune diseases requiring treatment, immunodeficient people, or people requiring immunosuppressive treatment;
- Patients with acute graft-versus-host disease (GvHD) or moderate-to-severe chronic GvHD within 4 weeks prior to screening;
- Patients with a history of allergy to any component of cell products;
- Pregnant, lactating females, and people (male or female) of childbearing potential who are unable to use effective contraception within 1 year after cell infusion; male people who plan to become pregnant within 1 year...
- Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.