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)

NCT05907603 | Completed Early Phase 1 DMC

• 1 other identifier: BHCT-RD13-02-06
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Hematologic Neoplasms; Hematologic Diseases

Outcome Measures

Primary Outcomes (3)

• 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 CR (complete response) /CRi (complete response with incomplete blood cell recovery) .

  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) .

  Evaluate at 12 weeks after CAR-T infusion

Secondary Outcomes (6)

• Objective response rate , ORR

  Up to 1 years after CAR-T infusion

• Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR

  Up to 1 years after CAR-T infusion

• Duration of remission (DOR)

  Up to 1 years after CAR-T infusion

• Event-free survival (EFS)

  Up to 1 years after CAR-T infusion

• The proportion of patients who receive hematopoietic stem cell transplantation

  Up to 1 years after CAR-T infusion

Study Arms (1)

Research Development 13(RD13)-02 cell infusion

EXPERIMENTAL

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

Interventions

RD13-02 cell infusion DRUG

CAR-T cells

Research Development 13(RD13)-02 cell infusion

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 3-70
• Diagnosis of r/r T-ALL/LBL/AML.
• CD7 positive expression
• Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
• 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
• Left ventricular ejection fraction ≥ 50% .
• Baseline oxygen saturation ≥ 92% on room air.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• The estimated survival time is more than 3 months.
• Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.

You may not qualify if:

• 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).
• Subjects with concomitant genetic syndromes associated with bone marrow failure states.
• Subjects with some cardiac conditions will be excluded.
• 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.
• History of malignancy other than non-melanoma skin cancer or carcinoma.
• Primary immune deficiency.
• Presence of uncontrolled infections.
• Subjects with some anticancer therapy before CAR-T infusion will be excluded.
• Active uncontrolled acute infections.
• Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
• Subjects who are receiving systemic steroid therapy prior to screening.
• Subjects with acute graft-versus-host disease (GvHD)
• Having received live/attenuated vaccine within 4 weeks prior to screening.
• History of allergy to any component of the cell therapy product.
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Kai Lin Xu，MD: lead
• Nanjing Bioheng Biotech Co., Ltd.: collaborator

Study Sites (1)

Affiliated hospital of Xuzhou medical college

Xuzhou, Jiangsu, 221000, China

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms; Hematologic Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: March 8, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)