NCT05907603CompletedEarly phase 1
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)
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
Source: ClinicalTrials.gov · Last updated 21 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 7 Jun 2023
- Start date
- Mar 2023
- Primary completion date
- Aug 2024
- Lead sponsor
- Kai Lin Xu，MD
- NCT number
- NCT05907603
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 8
- From Mar 2023 to the primary completion date, Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with concomitant genetic syndromes associated with bone marrow failure states.
- Subjects with some anticancer therapy before CAR-T infusion will be excluded.
- Subjects who are receiving systemic steroid therapy prior to screening.
- Having received live/attenuated vaccine within 4 weeks prior to screening.
Other illness
- 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.
- Presence of uncontrolled infections.
- Active uncontrolled acute infections.
- Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
- Subjects with acute graft-versus-host disease (GvHD)
- History of allergy to any component of the cell therapy product.
Other
- 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).
- Primary immune deficiency.
- Pregnant or breastfeeding women
- Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.
Who the study is looking for
- 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.
Age in the registry: 3 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated hospital of Xuzhou medical college Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.