Cell injection for patients with relapsed or refractory CD7-positive blood cancers

A Study on the Efficacy, Safety and Cellular Pharmacokinetics of RD13-02 Cell Injection in Patients With Relapsed or Refractory CD7-positive Hematological Malignancies

This study is testing a new cell therapy for people aged 3 to 70 with certain types of blood cancers to see if it can help them when other treatments haven't worked.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 3 Years to 70 Years
• Sex: All
• Sponsor: Wuhan Union Hospital, China (Academic / other)
• Drugs / interventions: CAR-T, Chimeric Antigen Receptor
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05895994 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, early phase 1 clinical trial designed to evaluate the safety and pharmacokinetics of CD7 Chimeric Antigen Receptor-T (CAR-T) therapy in patients diagnosed with relapsed or refractory T-Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma (LBL), or Acute Myelogenous Leukemia (AML). Participants aged 3 to 70 with CD7-positive expression will receive RD13-02 cell infusion. The study aims to assess the treatment's effectiveness in targeting specific hematological malignancies and monitor any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are patients aged 3-70 with relapsed or refractory CD7-positive T-ALL, LBL, or AML.

Not a fit: Patients with isolated extramedullary lesions or certain cardiac conditions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat blood cancers.

How similar studies have performed: Other studies using CAR-T therapies have shown promising results, indicating potential success for this approach.

Eligibility criteria

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 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. 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 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 Central Nervous System3(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. Subjects 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.

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 subjects ineligible for the study.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Heng Mei, Dr.

Conditions Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Hematologic Diseases