RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies

NCT ID: NCT05923541

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• 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, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.

Conditions

Hematologic Malignancies

Study Design

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

Study Groups

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

Universal CAR-T cells targeting CD7

Interventions

RD13-02 cell infusion

Universal CAR-T cells targeting CD7

Intervention Type: DRUG

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. 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.

• 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

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

KeshuZhou

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

BHCT-RD13-02-11

Identifier Type: -

Identifier Source: org_study_id