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NCT04553393
Decitabine-primed Tandem CD19/CD20 CAR T Cells Plus Epigenetic Agents in Aggressive r/r B-NHL With Huge Tumor Burden
Phase 1, PHASE2 trial testing Chidamide in Refractory or Relapsed Aggressive r/r B-NHL With Huge Tumor Burden in 80 participants. Status unknown.
8 September 2021
Quick facts
| Lead sponsor | Chinese PLA General Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 9 September 2020 |
| Primary completion | 8 September 2021 |
| Estimated completion | 8 September 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Chidamide — full drug profile →
- Decitabine (decitabine) — full drug profile →
- Chidamide and Decitabine — full drug profile →
- Decitabine-primed Tandem CAR19/20 engineered T cells — full drug profile →
Conditions studied
- Refractory or Relapsed Aggressive r/r B-NHL With Huge Tumor Burden — all drugs for Refractory or Relapsed Aggressive r/r B-NHL With Huge Tumor Burden →
Sponsor
Chinese PLA General Hospital
Who can join
Adults 16 to 65, any sex, with Refractory or Relapsed Aggressive r/r B-NHL With Huge Tumor Burden. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This open-label, multi-cohorts, phase 1/2 study has the primary objective of comparing decitabine-primed tandem CART 19/20 solo, with decitabine-primed tandem CART 19/20 plus chidamide, decitabine-primed tandem CART 19/20 plus decitabine, and decitabine-primed tandem CART 19/20 plus decitabine+chidamide in patients with aggressive B-NHL who were confirmed as Relapsed and/or Refractory B cell Non-Hodgkin's Lymphoma with hugh tumor burden (Sum of the Product of the perpendicular Diameters for multiple lesions, SPD ≥ 100cm\^2 or the largest-diameter of tumor ≥ 10 cm.).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04553393
- Europe PMC full search
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Related trials
Other trials of Chidamide
Trials testing the same drug.
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- NCT07493148 — Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL · Phase 2 · recruiting
- NCT07415980 — Phase Ib/II Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients · Phase 1, PHASE2 · not yet recruiting
- NCT07507318 — Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission · Phase 2 · not yet recruiting
- NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
Other Chinese PLA General Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04553393 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese PLA General Hospital
- Last refreshed: 4 December 2020
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/NCT04553393.
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