NCT04264078

Anti-CD7 U-CAR-T Cell Therapy for T/NK Cell Hematologic Malignancies

Status unknown EARLY_PHASE1 Last updated 28 June 2021

What this trial tests

EARLY_PHASE1 trial testing CD7 UCAR-T cells in T-cell Leukemia in 30 participants. Status unknown.

Timeline

1 March 2021

Primary endpoint
1 June 2022

1 June 2023

Quick facts

Lead sponsor	Xinqiao Hospital of Chongqing
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 March 2021
Primary completion	1 June 2022
Estimated completion	1 June 2023
Sites	1 location across China

Drugs / interventions tested

• CD7 UCAR-T cells — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Cytoxan — full drug profile →
• Melphalan (melphalan) — full drug profile →

Conditions studied

• T-cell Leukemia — all drugs for T-cell Leukemia →
• T-cell Lymphoma — all drugs for T-cell Lymphoma →

Sponsor

Xinqiao Hospital of Chongqing

Who can join

Adults 18 to 70, any sex, with T-cell Leukemia or T-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The prognosis of patients with relapsed and/or refractory T-cell hematologic malignancies is poor due to lacking sufficient treatment.Anti-CD(cluster of differentiation antigen)19 CAR(chimeric antigen receptor)-T cell therapies are efficient for patients with B-cell hematologic malignancies. As for T-cell hematologic malignancies, CD7 is a promising target expressed on most malignant T cells. The outcome of CD-7 CAR-T cell therapy pre-clinical experiments is cheerful.however, how to select the functional T cells from the malignant T cells is a challenge. In addition to this, auto-CAR-T cell therapy is not affordable for the majority of patients. Using T cells aphesis from healthy donors edited to avoid rejection of the host as the material of anti-CD7 universal CAR-T cells could be accessible and affordable, which is adapted for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies.

Publications & conference data

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

1. Recent advances in CAR-T cell engineering.
   Huang R, Li X, He Y, Zhu W, et al · · 2020 · cited 274× · PMID 32616000 · DOI 10.1186/s13045-020-00910-5
2. CAR-T cell combination therapy: the next revolution in cancer treatment.
   Al-Haideri M, Tondok SB, Safa SH, Maleki AH, et al · · 2022 · cited 106× · PMID 36419058 · DOI 10.1186/s12935-022-02778-6
3. Next generations of CAR-T cells - new therapeutic opportunities in hematology?
   Tomasik J, Jasiński M, Basak GW. · · 2022 · cited 98× · PMID 36389658 · DOI 10.3389/fimmu.2022.1034707
4. Allogeneic CAR Cell Therapy-More Than a Pipe Dream.
   Caldwell KJ, Gottschalk S, Talleur AC. · · 2020 · cited 98× · PMID 33488631 · DOI 10.3389/fimmu.2020.618427
5. Recent advances and applications of CRISPR-Cas9 in cancer immunotherapy.
   Liu Z, Shi M, Ren Y, Xu H, et al · · 2023 · cited 93× · PMID 36797756 · DOI 10.1186/s12943-023-01738-6
6. Choosing the Right Tool for Genetic Engineering: Clinical Lessons from Chimeric Antigen Receptor-T Cells.
   Irving M, Lanitis E, Migliorini D, Ivics Z, et al · · 2021 · cited 86× · PMID 34662233 · DOI 10.1089/hum.2021.173
7. Ready for Repair? Gene Editing Enters the Clinic for the Treatment of Human Disease.
   Ernst MPT, Broeders M, Herrero-Hernandez P, Oussoren E, et al · · 2020 · cited 67× · PMID 32775490 · DOI 10.1016/j.omtm.2020.06.022
8. Mechanisms of Immune Evasion in Acute Lymphoblastic Leukemia.
   Pastorczak A, Domka K, Fidyt K, Poprzeczko M, et al · · 2021 · cited 42× · PMID 33810515 · DOI 10.3390/cancers13071536