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Completed

NCT Number: NCT05907603

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)

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.

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Key information

Age range

3 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Affiliated hospital of Xuzhou medical college

Xuzhou, Jiangsu, 221000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.

Treatment and study plan

RD13-02 cell infusion

Drug

CAR-T cells

Primary outcomes

  1. Overall response rate (ORR)

    Time frame: Evaluate at 4 weeks after CAR-T infusion

    The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) .

  2. Overall response rate, ORR

    Time frame: Evaluate at 8 weeks after CAR-T infusion

    The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .

  3. Overall response rate, ORR

    Time frame: 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 outcomes

  1. Objective response rate , ORR

    Time frame: 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).

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

    Time frame: Up to 1 years after CAR-T infusion

    Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow

  3. Duration of remission (DOR)

    Time frame: 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

  4. Event-free survival (EFS)

    Time frame: Up to 1 years after CAR-T infusion

    The time from first achieving CR/CRi to relapse or death

  5. The proportion of patients who receive hematopoietic stem cell transplantation

    Time frame: Up to 1 years after CAR-T infusion

    The proportion of subjects who achieved remission after infusion who received Hematopoietic Stem Cell Transplantation (HSCT)

  6. Overall survival (OS)

    Time frame: Up to 1 years after CAR-T infusion

    The time from CAR-T infusion to death due to any cause

Sponsors and collaborators

Lead sponsor

Kai Lin Xu,MD

Other

Collaborators

  • Nanjing Bioheng Biotech Co., Ltd.

Registry information

Official study title

Clinical Study on Efficacy, Safety and Pharmacokinetics of CAR T Cell Injection in Patients With Recurrent or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematologic Malignancies

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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