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CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
Bu Faz 2 (Phase 2) çalışma, nükseden veya tedaviye dirençli B hücre kökenli lösemi ve lenfoma hastalarında, tedavi merkezinin kendi bünyesinde üretilen (point-of-care) CD19 hedefli CAR T-hücre tedavisinin uygulanabilirliğini tanımlamayı amaçlıyor. Çalışmaya, kemik iliğinde lenfoblast saptanan veya taramada minimal kalıntı hastalık (minimal residual disease) pozitif olan, nükseden/dirençli ya da kök hücre nakline uygun olmayan hastalar alınıyor. Katılımcı alımı sürüyor.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria:
1. Eligible disease conditions:
1. Relapsed or refractory B-cell ALL (all must be satisfied)
* Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening.
* Relapsed or refractory or ineligible for HSCT
* For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry
2. Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
2. Age at screening:
1. \< 18 years (paediatric group); or
2. ≥ 18 years (adult group)
3. Adequate organ functions:
4. Life expectancy more than 12 weeks.
5. Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening.
6. Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site.
Exclusion Criteria:
Patients with any of the following will be excluded:
* B-ALL with isolated extramedullary disease relapse
* Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.
* Patients with Burkitt's lymphoma/leukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell \[sIg positive and kappa or lambda restricted positivity\] ALL, with FAB L3 morphology and /or a MYC translocation)
* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
* Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening
* Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)
* Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines. Subjects with CNS-2 involvement or with history of CNS disease that have been actively treated are eligible.
* Patient has an investigational medicinal product within the last 30 days prior to screening.
* Pregnant or nursing women.
* Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CAR T-cell infusion. All female patients of childbearing potential must have a negative pregnancy test performed within 48 hours before infusion of CAR T-cells.
The following are not strictly exclusion criteria but must be discussed with PI/Site-PI:
* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
* Treatment with any prior gene therapy product
* Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy