RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies

Clinical Study on Efficacy, Safety and Cytopharmacokinetics of RD13-02 Cell Injection in the Treatment of Patients With Recurrent or Refractory CD7-positive Hematologic Malignancies

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancies
• Intervention / Treatment: Drug: RD13-02 cell infusion

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Shu Ke Zhou, Dr.; Phone Number: 13674902391; Email: drzhouks77@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan cancer hospital
      • Contact: Shu Ke Zhou, Dr.; Phone Number: 13674902391; Email: drzhouks77@163.com

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.
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. 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 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. Sujects 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.
13. Subjects with acute graft-versus-host disease (GvHD)
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 sujects 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; drugs use generic name : RD13-02 CAR-T cell injection; dosage form : Cell injection; dosage : 2×10^8 CAR+ T cells; frequency : Once.	Drug: RD13-02 cell infusion; Universal CAR-T cells targeting CD7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate, ORR	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).	Evaluate at 4 weeks after CAR-T infusion
Overall response rate, ORR	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).	Evaluate at 8 weeks after CAR-T infusion
Overall response rate, ORR	The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).	Evaluate at 12 weeks after CAR-T infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival, EFS	The time from first achieving CR/CRi to relapse or death	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
Overall response rate with 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
The proportion of patients who receive hematopoietic stem cell transplantation	The proportion of subjects who achieved remission after infusion who received HSCT	Up to 1 years after CAR-T infusion

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Collaborators: Nanjing Bioheng Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2023
• Primary Completion (Estimated): June 7, 2025
• Study Completion (Estimated): June 7, 2026

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: BHCT-RD13-02-11

Drug and device information, study documents

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