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)

Early Phase 1

Completed

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

• Registration Number: NCT05907603
• Lead Sponsor: Kai Lin Xu，MD

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/AML, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-08
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-18
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Research Development 13(RD13)-02 cell infusion	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.

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	Evaluate at 4 weeks after CAR-T infusion	The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) .
Overall response rate, ORR	Evaluate at 12 weeks after CAR-T infusion	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Affiliated hospital of Xuzhou medical college; 🇨🇳 Xuzhou, Jiangsu, China