CD7 CAR-T for Patients With r/r CD7+ T-ALL/T-LBL

Early Phase 1

Completed

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

• Registration Number: NCT05716113
• Lead Sponsor: He Huang

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-25
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-08
• Study Start: 2023-02-09
• 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: 20

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.

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
Dose-limiting toxicity and Maximum Tolerated dose	Up to 28 days after CAR-T cells infusion	The DLT is evaluated as the proportion of patients who experienced adverse events related to RD13-02 that meet the criteria for DLT events after the first infusion.

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
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,ORR	Evaluate at 4, 8, and 12 weeks after CAR-T infusion	The proportion of patients with CR (complete remission) /CRi (complete remission with incomplete blood count recovery); The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Overall response rate with 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 patients who receive hematopoietic stem cell transplantation
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)

The first affiliated hospital of medical college of zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China