Clinical trial NCT05716113: CD7 CAR-T for Patients With r/r CD7+ T-ALL/T-LBL
Official title: A Study for Safety, Efficacy and Cellular Pharmacokinetics of CD7 CAR-T Cell for Patients With Relapsed or Refractory CD7 Positive T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Nanjing Bioheng Biotech Co., Ltd.
First posted: 2023-02-08
Enrollment: 20
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, 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.
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. 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. Sujects with concomitant genetic syndromes associated with bone marrow failure states.
2. Sujects with some cardiac conditions will be excluded.
3. 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.
4. History of malignancy other than non-melanoma skin cancer or carcinoma.
5. Primary immune deficiency.
6. Presence of uncontrolled infections.
7. Sujects with some anticancer therapy before CAR-T infusion will be excluded.
8. Active uncontrolled acute infections.
9. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
10. Subjects who are receiving systemic steroid therapy prior to screening.
11. Subjects with acute graft-versus-host disease (GvHD)
12. Having received live/attenuated vaccine within 4 weeks prior to screening.
13. History of allergy to any component of the cell therapy product.
14. Pregnant or breastfeeding women
15. Any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.

Primary outcomes:
measure: Dose-limiting toxicity and Maximum Tolerated dose
timeFrame: Up to 28 days after CAR-T cells infusion
Secondary outcomes:
measure: Overall response rate,ORR
timeFrame: Evaluate at 4, 8, and 12 weeks after CAR-T infusion
measure: Overall response rate with 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: Hangzhou
country: China
facility: The first affiliated hospital of medical college of zhejiang university
state: Zhejiang
Study officials:
References: