Actively Recruiting
A Phase I Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Cells (CT0890B) in Patients With NKG2DL-Positive Relapsed/Refractory Acute Myeloid Leukemia
Led by Peking University People's Hospital · Updated on 2026-06-01
27
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
C
CARsgen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and behavior of CT0890B, an allogeneic CAR-T cell therapy, in patients with relapsed or refractory acute myeloid leukemia (AML) who have NKG2D ligand-positive disease. This Phase 1, open-label, dose-escalation study involves 12 to 27 participants and aims to understand how this treatment works in patients with this challenging form of leukemia. Participants receive a conditioning regimen with venetoclax, cytarabine, cyclophosphamide, and fludarabine over several days before receiving an infusion of CT0890B CAR-T cells at one of four dose levels. The study design follows an i3+3 dose-escalation approach to determine the best dose. The treatment period includes careful monitoring for adverse events and dose-limiting toxicities up to 28 days after infusion. During the 12 months following infusion, participants will be closely monitored through clinical assessments, laboratory tests, and pharmacokinetic studies to evaluate responses such as remission rates, survival, and minimal residual disease status. Safety will be tracked by observing adverse events and toxicities. Researchers will also assess how long the CAR-T cells persist in the body and their expansion over time, with total participation lasting up to one year after treatment.
CONDITIONS
Brief Title
Allogeneic CAR-T(CT0890B) in NKG2DL+ R/R AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, male or female
- Diagnosed relapsed or refractory acute myeloid leukemia with NKG2D ligand-positive disease
- Bone marrow blasts at least 5% by morphology
- Estimated life expectancy greater than 12 weeks
- ECOG performance status of 0 to 2
- Adequate organ function without ongoing supportive care, including cardiac, hepatic, renal, and coagulation parameters within specified limits
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia, BCR-ABL positive leukemia, or central nervous system leukemia
- History of epilepsy or other central nervous system diseases
- Previous autologous or allogeneic CAR-T therapy
- Stem cell transplantation within 12 weeks prior
- Prior immunotherapy targeting NKG2DL
- Active graft-versus-host disease or systemic corticosteroid treatment for GVHD
- Active uncontrolled systemic infection or requiring intravenous anti-infective agents
- Significant cardiac conditions including heart failure class III-IV, recent myocardial infarction or unstable angina, severe arrhythmias, or severe cardiomyopathy
- Active bleeding of clinical significance
- Need for supplemental oxygen to maintain saturation above 92%
- Severe chronic obstructive pulmonary disease or other lung diseases incompatible with CAR-T therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive a conditioning regimen including Venetoclax, Cytarabine, Cyclophosphamide, and Fludarabine before CAR-T cell infusion.
Visits from Day -9 to Day -3 for Venetoclax; Days -5 to -3 for other drugs
Duration - Day 0
Participants receive an infusion of CT0890B CAR-T cells at one of four dose levels as part of the treatment.
1 infusion visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety, efficacy, and cellular pharmacokinetics for up to 12 months after CAR-T cell infusion.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
Research Team
X
Xiangyu Zhao, M.D,Ph.D
M
Meng Lv, M.D., Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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