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Recruiting NCT06633328

CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia

Early Phase I Interventional Aplastic Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD7 CAR-T cells injection, Allogeneic hematopoietic stem cell transplantation.
Who it may be relevant to
Registry conditions: Aplastic Anemia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Study on the Safety and Efficacy of Donor Derived CD7 CAR-T Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation for the for Patients With Severe Aplastic Anemia

Overview

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with severe aplastic anemia

Detailed description

This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of CD7 CAR-T Bridging to allo-HSCT in the treatment of severe aplastic anemia.The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).

Interventions

  • Drug CD7 CAR-T cells injection
    CD7 CAR T cells treat patients with severe aplastic anemia
  • Other Allogeneic hematopoietic stem cell transplantation
    In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with severe aplastic anemia

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: Up to 28 days after Treatment]
  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years after Treatment]
Secondary outcome measures (4)
  • Allogeneic hematopoietic stem cell transplant implantation rate [Time frame: Up to 100 days after Treatment]
  • Time to neutrophil and platelet engraftment [Time frame: Up to 30 days after Treatment]
  • Disease-feesurvival，DFS [Time frame: Up to 2 years after Treatment]
  • Overall survival, OS [Time frame: Up to 2 years after Treatment]

Eligibility criteria

Inclusion criteria

  • Chinese expert consensus on the diagnosis and treatment of aplastic anemia（2017）, Diagnosis of severe aplastic anemia ，1. The degree of bone marrow cell proliferation < 25%, or 25%-50% but residual hematopoietic cells < 30%；2. With pancytopenia (at least two of the following peripheral blood parameters) : (1) absolute neutrophil <0.5×10\^9/L; (2) Platelet count< 20×10\^9/L; (3) The absolute value of reticulocytes <20×109/L;
  • Suitable donors (relatives) with allogeneic HSCT indications and at least haploid allogeneic transplantation;
  • Patients who are not suitable or unwilling to undergo traditional allogeneic hematopoietic stem cell transplantation;
  • creatinine clearance > 60ml/min; without liver invasion, serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 times the upper limit of the normal range. If there is liver invasion, serum erythrambirubin ≤ 3 times the upper limit of normal, and serum ALT and AST are both ≤ 5 times the upper limit of the normal range;
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
  • No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
  • Estimated survival time ≥ 3 months;
  • ECOG performance status 0 to 1;
  • Females and males of childbearing potential must agree to use adequate contraception prior to study entry, during study participation, and for 6 months after infusion (the safety of this therapy for unborn children is not known and has unknown risks);
  • Those who voluntarily participated in this trial and provided informed consent;

Exclusion criteria

  • Allergy to pre-treatment measures；
  • Those with acute graft versus host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening; Those who have received systemic drug therapy for GvHD within 4 weeks before the reinfusion；
  • History of epilepsy or other central nervous system disorders；
  • Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  • Less than 100 days after allogeneic hematopoietic stem cell transplantation；
  • Patients with HIV infection，Active infection of hepatitis B virus or hepatitis C virus，Uncured active infection；
  • The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
  • Received anti-cancer chemotherapy or other drug treatment within 2 weeks prior to screening;
  • Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Zhejiang University School of Medicine — Hanzhou

Identifiers

NCT: NCT06633328 · TXB2024009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗