NCT04538599

RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies

Completed Phase 1 Last updated 25 January 2022

What this trial tests

Phase 1 trial testing RD13-01 cell infusion in Hematologic Malignancies in 12 participants. Completed in 30 November 2021.

Timeline

10 September 2020

Primary endpoint
17 February 2021

30 November 2021

Quick facts

Lead sponsor	He Huang
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	10 September 2020
Primary completion	17 February 2021
Estimated completion	30 November 2021
Sites	1 location across China

Drugs / interventions tested

• RD13-01 cell infusion — full drug profile →

Conditions studied

• Hematologic Malignancies — all drugs for Hematologic Malignancies →

Sponsor

He Huang — full company profile →

Who can join

Adults 3 to 70, any sex, with Hematologic Malignancies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Genetically modified CD7-targeting allogeneic CAR-T cell therapy with enhanced efficacy for relapsed/refractory CD7-positive hematological malignancies: a phase I clinical study.
   Hu Y, Zhou Y, Zhang M, Zhao H, et al · · 2022 · cited 154× · PMID 36151216 · DOI 10.1038/s41422-022-00721-y
2. Immunotherapy in hematologic malignancies: achievements, challenges and future prospects.
   Tang L, Huang Z, Mei H, Hu Y. · · 2023 · cited 98× · PMID 37591844 · DOI 10.1038/s41392-023-01521-5
3. Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis.
   Hu Y, Zhang M, Yang T, Mo Z, et al · · 2024 · cited 92× · PMID 38657244 · DOI 10.1056/nejmoa2313812
4. Leveraging CRISPR gene editing technology to optimize the efficacy, safety and accessibility of CAR T-cell therapy.
   Lei T, Wang Y, Zhang Y, Yang Y, et al · · 2024 · cited 68× · PMID 39455854 · DOI 10.1038/s41375-024-02444-y
5. Current and future concepts for the generation and application of genetically engineered CAR-T and TCR-T cells.
   Hiltensperger M, Krackhardt AM. · · 2023 · cited 56× · PMID 36949949 · DOI 10.3389/fimmu.2023.1121030
6. Enhancing the safety of CAR-T cell therapy: Synthetic genetic switch for spatiotemporal control.
   Lu L, Xie M, Yang B, Zhao WB, et al · · 2024 · cited 52× · PMID 38394207 · DOI 10.1126/sciadv.adj6251
7. Chimeric antigen receptor-based natural killer cell immunotherapy in cancer: from bench to bedside.
   Zhang B, Yang M, Zhang W, Liu N, et al · · 2024 · cited 50× · PMID 38221520 · DOI 10.1038/s41419-024-06438-7
8. Latent human herpesvirus 6 is reactivated in CAR T cells.
   Lareau CA, Yin Y, Maurer K, Sandor KD, et al · · 2023 · cited 48× · PMID 37938768 · DOI 10.1038/s41586-023-06704-2