Clinical trial · Interventional
RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies
Clinical Study on Efficacy, Safety and Cytopharmacokinetics of RD13-02 Cell Injection in the Treatment of Patients With Recurrent or Refractory CD7-positive Hematologic Malignancies
NCT05923541CI-TRIAL-00082889completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RD13-02 cell infusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RD13-02 cell infusion
- description
- drugs use generic name : RD13-02 CAR-T cell injection; dosage form : Cell injection; dosage : 2×10\^8 CAR+ T cells; frequency : Once.
- interventionNames
- Drug: RD13-02 cell infusion
Primary outcomes (3)
- measure
- Overall response rate, ORR
- timeFrame
- Evaluate at 4 weeks after CAR-T infusion
- description
- The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
- measure
- Overall response rate, ORR
- timeFrame
- Evaluate at 8 weeks after CAR-T infusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 3-70 2. Diagnosis of r/r T-ALL/LBL. 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. 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 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. Sujects 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. 13. Subjects with acute graft-versus-host disease (GvHD) 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 sujects ineligible for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.