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)

• Status: Recruiting
• Trial end date: 2025-03-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kai Lin Xu，MD
• Collaborator: Nanjing Bioheng Biotech Co., Ltd.

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.