This is a Phase I/II Interventional, Open-label Treatment Study Designed to Evaluate the Safety and Efficacy of Anti CD 19/22 CAR- T Cells Immunotherapy for Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma.

NCT07162571 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 23.25
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to estimate the safety and the efficacy of anti-CD19/22 CAR- T cells immunotherapy for adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.

Conditions

Acute Lymphobkastic Leukemia; B Cell Lymphoma

Keywords

CD19/22 CAR-T cells; Acute Lymphobkastic Leukemia; B Cell lymphoma; dual targeting CAR-T therapy

Outcome Measures

Primary Outcomes (2)

• Phase I. Safety

  Number of Participants With Grade 3-5 Toxicities. Adverse events will be graded according to the CTCAE v5.0

  1 month post CAR-T cells infusion

• Phase II. Overall response rate

  Including complete response (CR) and partial response (PR) rates

  3 months post CAR-T cells infusion

Secondary Outcomes (4)

• Phase I. CAR-T proliferation

  3 months post CAR-T cells infusion

• Phase II. Efficacy: Overall survival rates

  12 months post CAR-T cells infusion

• Phase II. Progression-free survival rates

  12 months post CAR-T cells infusion

• Phase II. Duration of response

  12 months post CAR-T cells infusion

Study Arms (1)

CD19/22 CAR-T cells immunotherapy

EXPERIMENTAL

Biological: CD19/22 CAR-T cells

Interventions

CD19/22 CAR-T cells BIOLOGICAL

Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 150 x 10⁶ CD19/CD22 CAR-T cells

CD19/22 CAR-T cells immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 years.
• Willing and able to give written, informed consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
• Relapsed or refractory lymphoblastic leukemia/lymphoma.
• \- Chemotherapy-refractory disease after ≥1 lines of therapy
• \- Relapse after chemotherapy or after ASCT/Allo-HSCT.
• Adequate organ system function including - Creatinine clearance ≥40 cc/min.
• \- Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x upper limit of normal (ULN).
• \- Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome.
• \- Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram \[ECHO\] or
• \- Baseline oxygen saturation \>92% on room air and ≤Grade 1 dyspnoea.
• Have no active GVHD (Grade 2-4)
• Adequate bone marrow (BM) function - Absolute neutrophil count ≥1.0 × 10\^9/L.
• Absolute lymphocyte count ≥0.3 × 10\^9/L (at enrolment and prior to leukapheresis).
• Haemoglobin ≥80 g/L.

You may not qualify if:

• Females who are pregnant or lactating.
• History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
• Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion).
• Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.
• Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.
• History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months.
• \. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis.
• \. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).
• \. The following medications are excluded:
• Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to CAR-T administration. However, physiological replacement, topical, and inhaled steroids are permitted.
• Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or CAR-T cells infusion.
• Cytotoxic chemotherapies within 1 week of CAR-T cellsinfusion and 1 week prior to leukapheresis.
• Antibody therapy use including anti-CD20/19/22 therapy within 2 weeks prior to CAR-T cells infusion.
• Granulocyte-colony stimulating factor less than 14 days prior to leukapheresis.
• Live vaccine ≤4 weeks prior to enrolment.

Sponsors & Collaborators

• Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology: lead

Study Sites (1)

State Institution Minsk Scientific and Practical Center for Surgery, Transplantology, and Dermatology

Minsk, 220087, Belarus

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mikhail Uss. Head of the Department of Bone Marrow Transplantation, Researcher

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 9, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

BE (1)