T-Cell Acute Lymphoblastic Leukemia Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "T-Cell Acute Lymphoblastic Leukemia Pipeline Insight 2025" report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in T-Cell Acute Lymphoblastic Leukemia pipeline landscape. It covers the T-Cell Acute Lymphoblastic Leukemia pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the T-Cell Acute Lymphoblastic Leukemia Pipeline Report

* In March 2025, Janssen Research & Development LLC announced a study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.
* In March 2025, Juventas Cell Therapy Ltd . conducted a phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).
* In March 2025, Beam Therapeutics Inc. announced a phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to < 12 years), and a Phase 2 cohort.
* In March 2025, Wugen Inc. conducted a study is to evaluate the Composite Complete Remission Rate (CRc) of WU-CART-007 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) patients and to evaluate the efficacy of WU-CART-007 to induce complete Minimum Residual Disease (MRD) negative response.
* DelveInsight's T-Cell Acute Lymphoblastic Leukemia pipeline report depicts a robust space with 8+ active players working to develop 10+ pipeline therapies for T-Cell Acute Lymphoblastic Leukemia treatment.
* The leading T-Cell Acute Lymphoblastic Leukemia Companies such as Ascentawits Pharmaceuticals, Wugen, Jazz Pharmaceuticals, iCellGene Therapeutics, HebeiSenlangBiotechnology, Nanjing Bioheng Biotech , and others.
* Promising T-Cell Acute Lymphoblastic Leukemia Therapies such as WU-CART-007, LY3039478, Dexamethasone, Vincristine, Daunorubicin , and others.

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T-Cell Acute Lymphoblastic Leukemia Emerging Drugs Profile

* AST-3424: Ascentawits Pharmaceuticals

AST-3424 is a first-in-class small molecule coupled targeted drug developed by the Aixindawei R&D team that relies on AKR1C3 enzyme activation. It selectively cleaves the aldehyde-keto reductase family 1 member C3 (AKR1C3) into a cytotoxic active form (AST-2660). The diaziridine (AST-2660) released by AST-3424 is similar to the standard chemotherapy drugs thiotepa and mitomycin C, which alkylates and cross-links DNA at the N7 (or O6) position of guanine, leading to cell death. SWOG was commissioned by the National Cancer Institute (NCI) to conduct a Phase II clinical study of relapsed and refractory T-ALL. The Phase II clinical study of relapsed and refractory T-ALL is a single-arm, open-label, OBI-3424 monotherapy (one treatment cycle every 21 days, with administration on the 1st and 8th days) led by SWOG (Southwest Oncology Group) with the National Cancer Institute as the main sponsor. The commercial rights for AST-3424 outside of Asia belong to the company's global partner OBI. Currently, the drug is in Phase II stage of its development for the treatment of T-ALL.

* WU-CART-007: Wugen

WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. WU-CART-007 is manufactured using healthy donor-derived T-cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase I/II clinical trial for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). WU-CART-007 has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration for the treatment of R/R T-ALL/LBL.

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T-Cell Acute Lymphoblastic Leukemia Companies

Ascentawits Pharmaceuticals, Wugen, Jazz Pharmaceuticals, iCellGene Therapeutics, HebeiSenlangBiotechnology, Nanjing Bioheng Biotech, and others.

T-Cell Acute Lymphoblastic Leukemia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Parenteral
* Intravenous
* Subcutaneous
* Topical.

T-Cell Acute Lymphoblastic Leukemia Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

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Scope of the T-Cell Acute Lymphoblastic Leukemia Pipeline Report

* Coverage- Global
* T-Cell Acute Lymphoblastic Leukemia Companies- Ascentawits Pharmaceuticals, Wugen, Jazz Pharmaceuticals, iCellGene Therapeutics, HebeiSenlangBiotechnology, Nanjing Bioheng Biotech, and others.
* T-Cell Acute Lymphoblastic Leukemia Therapies- WU-CART-007, LY3039478, Dexamethasone, Vincristine, Daunorubicin , and others.
* T-Cell Acute Lymphoblastic Leukemia Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* T-Cell Acute Lymphoblastic Leukemia Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive Summary
* T-Cell Acute Lymphoblastic Leukemia: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Late Stage Products (Phase III)
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* AST-3424: Ascentawits Pharmaceuticals
* Drug profiles in the detailed report.....
* Early stage products (Phase I)
* WU-CART-007: Wugen
* Drug profiles in the detailed report.....
* Inactive Products
* T-Cell Acute Lymphoblastic Leukemia Key Companies
* T-Cell Acute Lymphoblastic Leukemia Key Products
* T-Cell Acute Lymphoblastic Leukemia- Unmet Needs
* T-Cell Acute Lymphoblastic Leukemia- Market Drivers and Barriers
* T-Cell Acute Lymphoblastic Leukemia- Future Perspectives and Conclusion
* T-Cell Acute Lymphoblastic Leukemia Analyst Views
* T-Cell Acute Lymphoblastic Leukemia Key Companies
* Appendix

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