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)

Neoplasms Clinical Trial

Official title:

Clinical Study on Efficacy, Safety and Pharmacokinetics of CAR T Cell Injection in Patients With Recurrent or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907603
• Other study ID #: BHCT-RD13-02-06
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 8, 2023
• Est. completion date: March 8, 2025

Study information

• Verified date: June 2023
• Source: Xuzhou Medical University
• Contact: Jiang Cao, MD
• Phone: +86-13852432263
• Email: zimu05067[@]163.com
• 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/AML, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: March 8, 2025
• Est. primary completion date: March 8, 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/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.

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematologic Neoplasms
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Affiliated hospital of Xuzhou medical college	Xuzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Kai Lin Xu,MD	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 complete response (CR) /complete response with incomplete blood cell recovery (CRi) .	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) .	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) .	Evaluate at 12 weeks after CAR-T infusion
Secondary	Objective response rate , ORR	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and partial response (PR).	Up to 1 years after CAR-T infusion
Secondary	Overall response rate with Minimal Residual Disease (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 Hematopoietic Stem Cell Transplantation (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