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NCT07205315
A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic Anemia
EARLY_PHASE1 trial testing GT801 Injection in B-cell Acute Lymphoblastic Leukemia (B-ALL) in 28 participants. Currently enrolling.
30 November 2027
Quick facts
| Lead sponsor | Grit Biotechnology |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 26 September 2025 |
| Primary completion | 30 November 2027 |
| Estimated completion | 31 August 2028 |
| Sites | 2 locations across China |
Drugs / interventions tested
- GT801 Injection — full drug profile →
Conditions studied
- B-cell Acute Lymphoblastic Leukemia (B-ALL) — all drugs for B-cell Acute Lymphoblastic Leukemia (B-ALL) →
- Chronic Lymphocytic Leukemia (CLL) — all drugs for Chronic Lymphocytic Leukemia (CLL) →
- B-cell Non-Hodgkin's Lymphoma (B-NHL) — all drugs for B-cell Non-Hodgkin's Lymphoma (B-NHL) →
- Autoimmune Hemolytic Anemia (AIHA) — all drugs for Autoimmune Hemolytic Anemia (AIHA) →
Sponsor
Grit Biotechnology — full company profile →
Who can join
Adults 18 to 75, any sex, with B-cell Acute Lymphoblastic Leukemia (B-ALL) or Chronic Lymphocytic Leukemia (CLL). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed/refractory CD19-positive B-cell hematologic malignancies and autoimmune hemolytic anemia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
In vivo CAR-T therapy: latest updates from the 2025 ASH annual meeting.
Wang S, Kong R, Zhong G, Yang X, et al · · 2026 · PMID 42174685 · DOI 10.1186/s40364-026-00938-8
Verify or expand the search:
- PubMed search for NCT07205315
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GT801 Injection
Trials testing the same drug.
- NCT07333118 — A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate-to-Severe Refractor · EARLY_PHASE1 · recruiting
Other recruiting trials for B-cell Acute Lymphoblastic Leukemia (B-ALL)
Currently open trials in the same condition.
- NCT07109219 — Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia · Phase 1, PHASE2 · recruiting
- NCT06514768 — JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL) · EARLY_PHASE1 · recruiting
- NCT06137118 — AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia · Phase 1, PHASE2 · recruiting
- NCT05397496 — Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies · Phase 1 · active not recruiting
Other Grit Biotechnology trials
Trials by the same sponsor.
- NCT07534813 — A Single-Arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT307) in the Treatment of Metastatic · NA · not yet recruiting
- NCT07389499 — A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediate · EARLY_PHASE1 · recruiting
- NCT07253259 — A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or · EARLY_PHASE1 · recruiting
- NCT07333118 — A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate-to-Severe Refractor · EARLY_PHASE1 · recruiting
- NCT07122076 — GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
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 NCT07205315 (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 Grit Biotechnology
- Last refreshed: 26 December 2025
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/NCT07205315.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing