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)

Last updated: November 20, 2024
Sponsor: Kai Lin Xu,MD
Overall Status: Completed

Phase

1

Condition

Hematologic Neoplasms

Neoplasms

Red Blood Cell Disorders

Treatment

RD13-02 cell infusion

Clinical Study ID

NCT05907603
BHCT-RD13-02-06
  • Ages 3-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 alanineaminotransferase(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 theinformed consent.

Exclusion

Exclusion Criteria:

  1. For AML patients, there are acute promyelocytic leukemia (APL) and Abelson MurineLeukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemiawith acute(CML)-BC).

  2. Subjects with concomitant genetic syndromes associated with bone marrow failurestates.

  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 mightcompromise the ability of the subject to compliance with the obligations under theprotocol.

  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 latenthepatitis 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 subjectsineligible for the study.

Study Design

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: RD13-02 cell infusion
Phase: 1
Study Start date:
March 08, 2023
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Affiliated hospital of Xuzhou medical college

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

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