Research Development13(RD13)-02 Cell Injection in Patients With Relapsed or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematological Malignancies

A Study on the Efficacy, Safety and Cellular Pharmacokinetics of RD13-02 Cell Injection in Patients With Relapsed or Refractory CD7-positive Hematological Malignancies

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory T-Acute Lymphoblastic Leukemia(ALL)/Lymphoblastic Lymphoma(LBL)/Acute Myelogenous Leukemia(AML), and to evaluate the pharmacokinetics of CD7 CAR-T in patients。

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Intervention / Treatment: Drug: RD13-02 cell infusion

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Heng Mei, Dr.; Phone Number: 13886160811; Email: hmei@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital, Huazhong University of Science and Technology
      • Contact: Yinqiang Zhang; Phone Number: 15007101371; Email: zyq_107@126.com
      • Principal Investigator: Heng Mei, M.D., Ph.D
      • Contact: Heng Mei, M.D., Ph.D; Email: hmei@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. 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 Central Nervous System3(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. Subjects 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.

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 subjects ineligible for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RD13-02 cell infusion	Drug: RD13-02 cell infusion; CAR-T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall response rate (ORR)	The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)	Evaluate at 8 weeks after CAR-T infusion
Overall response rate (ORR)	The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)	Evaluate at 12 weeks after CAR-T infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Event-free survival (EFS)	The time from first achieving CR/CRi to relapse or death	Up to 1 years after CAR-T infusion
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
Overall survival (OS)	The time from CAR-T infusion to death due to any cause	Up to 1 years after CAR-T infusion

Collaborators and Investigators

• Sponsor: MEI HENG
• Collaborators: Nanjing Bioheng Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Estimated): February 20, 2025
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: February 18, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Hematologic Neoplasms; Hematologic Diseases; Neoplasms by Site
• Other Study ID Numbers: BHCT-RD13-02-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No