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

Early Phase 1

Recruiting

• Conditions: Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms; Neoplasms
• Interventions: Drug: RD13-02 cell infusion

• Registration Number: NCT05895994
• Lead Sponsor: MEI HENG

Brief Summary

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。

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-18
• Study Start: 2023-03-10
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-08
• Last Update Submitted: 2023-06-08
• Study First Posted: 2023-06-09
• Last Update Posted: 2023-06-09
• Primary Completion: 2025-02-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RD13-02 cell infusion	RD13-02 cell infusion	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Objective response rate , ORR	Up to 1 years after CAR-T infusion	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and partial response (PR).
Event-free survival (EFS)	Up to 1 years after CAR-T infusion	The time from first achieving CR/CRi to relapse or death
Duration of remission (DOR)	Up to 1 years after CAR-T infusion	The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR	Up to 1 years after CAR-T infusion	Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow
The proportion of patients who receive hematopoietic stem cell transplantation	Up to 1 years after CAR-T infusion	The proportion of subjects who achieved remission after infusion who received Hematopoietic Stem Cell Transplantation (HSCT)
Overall survival (OS)	Up to 1 years after CAR-T infusion	The time from CAR-T infusion to death due to any cause

Trial Locations

Locations (1)

Union Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China