A Clinical Study of CAR-T Treating Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Lymphoma

A Single-arm, Open-label, Single-center Clinical Study: Safety and Efficacy of Anti-CD7 CAR-T in the Treatment of Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Lymphoma

NCT05909527•Guangzhou Bio-gene Technology Co., Ltd

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Summary

This study is a single arm, non blind, randomized, single center study aimed at evaluating the safety, pharmacokinetic characteristics, and preliminary efficacy of CD7 CAR-T cell injection in r/r T-ALL/LBL subjects.

Detailed Description

This study is a single dose escalation and dose extension study. The main purpose of the IIT clinical trial is to evaluate the safety, tolerance, pharmacokinetic characteristics, and preliminary efficacy of CAR-T cells in r/r T-ALL/LBL subjects. The study includes two parts: the dose increasing stage (Part A) and the dose expanding stage (Part B) of CD7 CAR-T cell injection. The study plans to enroll 30 subjects, of which approximately 12-18 are planned to be enrolled in the dose escalation phase, and the remaining are planned to be enrolled in the dose escalation phase.

Eligibility

Age

2 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient or his/her guardian understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examination and treatment of the study procedure;
•2. Age 2\~60 (including threshold), regardless of gender;
•3. According to the WHO 2016 standard, the patients with relapsed/refractory acute T-lymphoblastic leukemia/lymphoma (including early pre T-lymphoblastic leukemia) who failed to receive standard treatment or lacked effective treatment methods met any of the following criteria:
•1\) Recurrence: disease recurrence is confirmed after receiving at least two treatment schemes to achieve complete remission in the past, or disease recurrence occurs after stem cell transplantation to achieve complete remission; 2) Difficult to treat: Have received at least two treatment schemes in the past, and failed to reach CR (for leukemia patients) or PR (for lymphoma patients) after the last treatment, or failed to get remission or develop disease after stem cell transplantation;
•4\. During screening, the bone marrow examination was definitely diagnosed as CD7 positive by flow cytometry and/or the tumor was definitely diagnosed as CD7 positive by pathological immunohistochemistry, and the positive rate of CD7 was ≥ 70%;
•5\. The patient has recovered from the toxicity of the previous treatment, that is, the CTCAE toxicity grade is less than grade 2 (unless the abnormality is related to the tumor or is judged to be stable by the researcher, which has little impact on the safety or efficacy);
•6\. The ECOG physical condition score is 0\~2 and the expected life span is more than 3 months;
•7\. With appropriate organ functions:
•1. Glutamic alanine transaminase (ALT) and glutamic oxaloacetic transaminase (AST) ≤ 3 times the upper limit of normal value (ULN). The researcher judges that ALT and AST are abnormal due to diseases (such as liver infiltration or bile duct obstruction), and their indicators can be relaxed to ≤ 5 times ULN;
•2. Total bilirubin ≤ 1.5 times ULN;
+4 more criteria

Exclusion Criteria

•1. When collecting and preparing CAR-T blood, those with a tumor load greater than 70%;
•2. Have malignant tumors other than T-cell hematological malignancies within 5 years, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, breast ductal carcinoma in situ after radical resection cancer.
•3. CNS leukemia patients with clinical symptoms.
•4. Hepatitis B surface antigen (HBsAg) is positive, hepatitis B core antibody (HBcAb) is positive and the detection of hepatitis B virus (HBV) DNA titer in peripheral blood is not within the normal reference value range; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Positive individuals for cytomegalovirus (CMV) DNA testing; Syphilis test positive.
•5. Those with a history of severe allergies or known any of the active ingredients, excipients or mouse-derived products contained in the drug, or those allergic to xenogeneic proteins in this trial, including lymphocyte depletion regimens. Severe allergy history is defined as an allergic reaction of grade two or above, and any of the following clinical manifestations occur when an allergic reaction occurs: airway obstruction (runny nose, cough, wheezing, dyspnea), hypercardia tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiration, cardiac arrest.
•6. Severe heart disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (refractory Hypertension is defined as: on the basis of improving lifestyle, a reasonable tolerable and sufficient amount of ≥3 kinds of antihypertensive drugs (including diuretics) has been used for \> 1 month and the blood pressure has not reached the standard, or the blood pressure can only be achieved effective control after taking ≥4 kinds of antihypertensive drugs.
•7. Have unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy.
•8. Those who have received organ transplants or are about to receive organ transplants (except for hematopoietic stem cell transplants).
•9. Patients with acute and chronic graft-versus-host disease (GVHD).
•10. Patients who received hematopoietic stem cell transplantation within 6 months before screening and who have active GVHD after stopping Immunosuppressive drug therapy.
+9 more criteria

Locations (1)

Hebei Yanda Hospital

Langfang, Hebei, China

Key Dates

Start Date

May 1, 2023

Primary Completion Date

August 1, 2028

Completion Date

August 1, 2028

Last Updated

March 17, 2026

Conditions

T-Cell Acute Lymphocytic Leukemia

Interventions

CD7 CAR-T

BIOLOGICAL

CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-cell Malignancies

NCT06316856

T-Cell Acute Lymphocytic LeukemiaAcute Lymphoblastic Leukemia, in Relapse+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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