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)

NCT ID: NCT05907603

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2024-08-31

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.

Conditions

Neoplasms; Hematologic Neoplasms; Hematologic Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Research Development 13(RD13)-02 cell infusion

drugs use generic name : RD13-02 CAR-T cell injection ; dosage form : Cell injection ; dosage : 2×10\^8 CAR+ T cells ; frequency : Once.

Group Type: EXPERIMENTAL

RD13-02 cell infusion

Intervention Type: DRUG

CAR-T cells

Interventions

RD13-02 cell infusion

CAR-T cells

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Bioheng Biotech Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Kai Lin Xu，MD

OTHER

Sponsor Role: lead

Responsible Party

Kai Lin Xu，MD

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Affiliated hospital of Xuzhou medical college

Xuzhou, Jiangsu, China

Countries

China

Other Identifiers

BHCT-RD13-02-06

Identifier Type: -

Identifier Source: org_study_id