Clinical trial NCT06732492: RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
Official title: RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: NK T-Cell Lymphoma
CART Therapy
CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Nanjing Bioheng Biotech Co., Ltd.
First posted: 2024-12-13
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
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 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory natural killer/T cell lymphoma, and to evaluate the pharmacokinetics of CD7 CAR-T in patients。


Eligibility criteria: Inclusion Criteria:

1. Age 3-70
2. Diagnosis of r/r NK/T lymphoma.
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. Subjects with concomitant genetic syndromes associated with bone marrow failure states.
2. Isolated extramedullary lesions
3. Subjects with some cardiac conditions will be excluded.
4. With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).
5. 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.
6. History of malignancy other than non-melanoma skin cancer or carcinoma.
7. Primary immune deficiency.
8. Presence of uncontrolled infections.
9. Subjects with some anticancer therapy before CAR-T infusion will be excluded.
10. Active uncontrolled acute infections.
11. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
12. Subjects who are receiving systemic steroid therapy prior to screening.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Evaluate at 4 weeks after CAR-T infusion
Secondary outcomes:
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: Overall survival (OS)
timeFrame: Up to 1 years after CAR-T infusion
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital
state: Hubei
Study officials:
References: