Clinical trial NCT05907603: Research Development（RD）13-02 Chimeric Antigen Receptor(CAR) -T Cell Injection for Patients With r/r Cluster Of Differentiation 7（CD7）+ T-Acute Lymphoblastic Leukemia(ALL)/T-Lymphoblastic Lymphoma(LBL) /Acute Myelogenous Leukemia(AML)
Official title: Clinical Study on Efficacy, Safety and Pharmacokinetics of CAR T Cell Injection in Patients With Recurrent or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Neoplasms
Hematologic Neoplasms
Hematologic Diseases
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Bioheng Biotech Co., Ltd.
First posted: 2023-06-18
Enrollment: 8
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL/AML, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.


Eligibility criteria: Inclusion Criteria:

1. Age 3-70
2. Diagnosis of r/r T-ALL/LBL/AML.
3. CD7 positive expression
4. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
5. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) \< 3×upper limit of normal, Total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl
6. Left ventricular ejection fraction ≥ 50% .
7. Baseline oxygen saturation ≥ 92% on room air.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
9. The estimated survival time is more than 3 months.
10. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. For AML patients, there are acute promyelocytic leukemia (APL) and Abelson Murine Leukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemia with acute(CML)-BC).
2. Subjects with concomitant genetic syndromes associated with bone marrow failure states.
3. Subjects with some cardiac conditions will be excluded.
4. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
5. History of malignancy other than non-melanoma skin cancer or carcinoma.
6. Primary immune deficiency.
7. Presence of uncontrolled infections.
8. Subjects with some anticancer therapy before CAR-T infusion will be excluded.
9. Active uncontrolled acute infections.
10. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
11. Subjects who are receiving systemic steroid therapy prior to screening.
12. Subjects with acute graft-versus-host disease (GvHD)
13. Having received live/attenuated vaccine within 4 weeks prior to screening.
14. History of allergy to any component of the cell therapy product.
15. Pregnant or breastfeeding women
16. Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Evaluate at 4 weeks after CAR-T infusion
measure: Overall response rate, ORR
timeFrame: Evaluate at 8 weeks after CAR-T infusion
measure: Overall response rate, ORR
timeFrame: Evaluate at 12 weeks after CAR-T infusion
Secondary outcomes:
measure: Objective response rate , ORR
timeFrame: Up to 1 years after CAR-T infusion
measure: Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR
timeFrame: Up to 1 years after CAR-T infusion
measure: Duration of remission (DOR)
timeFrame: Up to 1 years after CAR-T infusion
measure: Event-free survival (EFS)
timeFrame: Up to 1 years after CAR-T infusion
measure: The proportion of patients who receive hematopoietic stem cell transplantation
timeFrame: Up to 1 years after CAR-T infusion
measure: Overall survival (OS)
timeFrame: Up to 1 years after CAR-T infusion
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Affiliated hospital of Xuzhou medical college
state: Jiangsu
Study officials:
References: