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NCT06078306
CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).
Status unknown
Phase 2
Last updated 22 April 2024
What this trial tests
Phase 2 trial testing Azacitidine Injection in B Acute Lymphoblastic Leukemia in 20 participants. Status unknown.
Timeline
20 April 2024
Primary endpoint
10 September 2024
10 September 2024
10 September 2025
Quick facts
| Lead sponsor | The First Affiliated Hospital of Soochow University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 20 April 2024 |
| Primary completion | 10 September 2024 |
| Estimated completion | 10 September 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Azacitidine Injection — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
- CD19CD22 CAR-T — full drug profile →
Conditions studied
- B Acute Lymphoblastic Leukemia — all drugs for B Acute Lymphoblastic Leukemia →
- Ph-Negative ALL — all drugs for Ph-Negative ALL →
- High Risk Acute Lymphoblastic Leukemia — all drugs for High Risk Acute Lymphoblastic Leukemia →
Sponsor
The First Affiliated Hospital of Soochow University
Who can join
Adults 18 to 65, any sex, with B Acute Lymphoblastic Leukemia or Ph-Negative ALL. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
The epigenetic hallmarks of immune cells in cancer.
Ji Y, Xiao C, Fan T, Deng Z, et al · · 2025 · cited 28× · PMID 40038722 · DOI 10.1186/s12943-025-02255-4 -
Mechanisms of Resistance to CAR T-Cells and How to Overcome Them.
Legato L, Bisio M, Fasano F, Benevolo Savelli C, et al · · 2025 · cited 3× · PMID 40981226 · DOI 10.3390/mps8050108 -
Novel therapeutic strategies targeting resistance mechanisms in hematologic malignancies: from BCL2 inhibition to immunomodulatory approaches.
Han Q, Jiang S, Chen J, Xue L. · · 2025 · cited 1× · PMID 41657780 · DOI 10.3389/fphar.2025.1742651 -
Combining Small-Molecular Compounds With CAR T-Cell Therapy: Novel Strategies for Enhanced Cancer Immunotherapy.
Yi R, Zhang Z, Yang Y, Zhu H. · · 2026 · PMID 41978748 · DOI 10.1002/cai2.70053 -
The use of venetoclax in the treatment of acute lymphoblastic leukemia-a systematic review.
Kowalczyk A, Zarychta J, Zawitkowska J, Lejman M. · · 2026 · PMID 41523908 · DOI 10.1177/17588359251403912
Verify or expand the search:
- PubMed search for NCT06078306
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Azacitidine Injection
Trials testing the same drug.
- NCT06150040 — Acute Myeloid Leukemia Treated With With NETrin Abs in Combination With [AZACITIDINE + VENETOCLAX] · Phase 1, PHASE2 · terminated
- NCT06389292 — A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia · Phase 3 · recruiting
- NCT06279338 — A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score · NA · unknown
- NCT05559008 — A Umbrella Study in R/R PTCL Guided by Molecular Subtypes · Phase 1, PHASE2 · unknown
- NCT05048615 — Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML · Phase 2 · completed
Other recruiting trials for B Acute Lymphoblastic Leukemia
Currently open trials in the same condition.
- NCT06710418 — Evaluating the Effects of Hemoglobin Threshold-specific Packed Red Blood Cell Transfusions on Quality of Life and Functi · NA · recruiting
- NCT06317662 — Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual C · Phase 2 · recruiting
- NCT06124157 — A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adole · Phase 2 · recruiting
- NCT05602194 — Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma · Phase 3 · recruiting
- NCT05707273 — CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission · Phase 1 · active not recruiting
Other The First Affiliated Hospital of Soochow University trials
Trials by the same sponsor.
- NCT07350863 — U69-CART-Cells For R/R T-ALL · Phase 1 · recruiting
- NCT06985498 — Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL · Phase 2 · not yet recruiting
- NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
- NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients · NA · recruiting
- NCT07511426 — U96-CAR-T-Cells For R/R B-ALL · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT06078306 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Soochow University
- Last refreshed: 22 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06078306.
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