RD13-02 CAR-T Cell Injection for Patients With r/r CD7+ T-ALL/T-LBL

Neoplasms Clinical Trial

Official title:

Efficacy, Safety and Cytopharmacokinetics of RD13-02 Cell Injection in the Treatment of Patients With Recurrent or Refractory CD7-positive Hematologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902845
• Other study ID #: BHCT-RD13-02-08
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 30, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2023
• Source: Anhui Provincial Hospital
• Contact: Yu Xiao Zhu, MD
• Phone: +86-15255456091
• Email: xiaoyuz[@]ustc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematologic Neoplasms
• Neoplasms

Intervention

Drug:
• RD13-02 cell infusion
CAR-T cells

Locations

Country	Name	City	State
China	The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
Xiaoyu Zhu	Nanjing Bioheng Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate, ORR	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).	Evaluate at 4 weeks after CAR-T infusion
Primary	Overall response rate, ORR	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).	Evaluate at 8 weeks after CAR-T infusion
Primary	Overall response rate, ORR	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).	Evaluate at 12 weeks after CAR-T infusion
Secondary	Overall response rate with MRD-negative, MRD-ORR	Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow	Up to 1 years after CAR-T infusion
Secondary	Duration of remission, DOR	The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion	Up to 1 years after CAR-T infusion
Secondary	Event-free survival, EFS	The time from first achieving CR/CRi to relapse or death	Up to 1 years after CAR-T infusion
Secondary	The proportion of patients who receive hematopoietic stem cell transplantation	The proportion of subjects who achieved remission after infusion who received HSCT.	Up to 1 years after CAR-T infusion
Secondary	Overall survival, OS	The time from CAR-T infusion to death due to any cause	Up to 1 years after CAR-T infusion