Clinical trial · Interventional
RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies
NCT04538599CI-TRIAL-00056145completedPhase 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 study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies. And to evaluate the efficacy and pharmacokinetics of RD13-01 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 |
|---|---|---|---|
| RD13-01 cell infusion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RD13-01 cell infusion
- interventionNames
- Drug: RD13-01 cell infusion
Primary outcomes (1)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- 4 weeks after infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 3 to 70 years. 2. Diagnosis of r/r T-ALL/NK-ALL, T-LBL, or T-NHL (including PTCL-NOS, AITL, ALCL, Extranodal NK/T cell lymphoma). 3. ECOG: 0-2. 4. Life expectancy greater than 12 weeks. 5. Cardiac left ventricle ejection fraction ≥50%. 6. Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent. Exclusion Criteria: 1. Pregnant or lactating. 2. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive. 3. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs. 4. Participated in other clinical studies within 2 weeks prior to screening. 5. History of alcoholism, drug abuse or mental illness. 6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
References
Publications (2)
- DERIVEDHu Y, Zhang M, Yang T, Mo Z, Wei G, Jing R, Zhao H, Chen R, Zu C, Gu T, Xiao P, Hong R, Feng J, Fu S, Kong D, Xu H, Cui J, Huang S, Liang B, Yuan X, Cui Q, Guo H, Yu Y, Feng Y, Jin C, Ren J, Chang AH, Wang D, Huang H. Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis. N Engl J Med. 2024 Apr 25;390(16):1467-1480. doi: 10.1056/NEJMoa2313812. PMID 38657244
- DERIVEDHu Y, Zhou Y, Zhang M, Zhao H, Wei G, Ge W, Cui Q, Mu Q, Chen G, Han L, Guo T, Cui J, Jiang X, Zheng X, Yu S, Li X, Zhang X, Chen M, Li X, Gao M, Wang K, Zu C, Zhang H, He X, Wang Y, Wang D, Ren J, Huang H. Genetically modified CD7-targeting allogeneic CAR-T cell therapy with enhanced efficacy for relapsed/refractory CD7-positive hematological malignancies: a phase I clinical study. Cell Res. 2022 Nov;32(11):995-1007. doi: 10.1038/s41422-022-00721-y. Epub 2022 Sep 23. PMID 36151216