Hematologic Malignancies
Conditions
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.
Interventions
Universal CAR-T cells targeting CD7
Sponsors
Nanjing Bioheng Biotech Co., Ltd.
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
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. 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 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. Sujects 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. 13. Subjects with acute graft-versus-host disease (GvHD) 14. Having received live/attenuated vaccine within 4 weeks prior to screening. 15. History of allergy to any component of the cell therapy product. 16. Pregnant or breastfeeding women 17. Any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate, ORR | Evaluate at 4 weeks after CAR-T infusion | The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate with MRD-negative, MRD-ORR | Up to 1 years after CAR-T infusion | Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow |
| Duration of remission, DOR | Up to 1 years after CAR-T infusion | The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion |
| Event-free survival, EFS | Up to 1 years after CAR-T infusion | The time from first achieving CR/CRi to relapse or death |
| The proportion of patients who receive hematopoietic stem cell transplantation | Up to 1 years after CAR-T infusion | The proportion of subjects who achieved remission after infusion who received HSCT |
| Overall survival, OS | Up to 1 years after CAR-T infusion | The time from CAR-T infusion to death due to any cause |
Countries
China
Outcome results
None listed