Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05648019
Other study ID # SHCELL18P1
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 15, 2022
Est. completion date December 2026

Study information

Verified date March 2023
Source KK Women's and Children's Hospital
Contact Shui Yen Soh, MD
Phone +65 6394 1045
Email soh.shui.yen@singhealth.com.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma.


Description:

This is a single arm, open-label, multi-center, phase II feasibility study to deliver point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma. The study consists of the following phases: 1. Screening phase: Eligibility; enrolment 2. Preparatory phase: Bridging therapy (if required); leukapheresis; CAR T manufacturing; lymphodepletion. 3. Treatment phase: Infusion of single dose of anti-CD19 CAR T-cells 4. Follow-up Phase: Efficacy and safety monitoring up to 24 months


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 0 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Anti-CD19 CAR T-cells
A target per-protocol dose of vi able CD19 CAR transduced T-cells will consist of a single infusion of 0.2 to 5.0 x 10e6 lentiviral-transduced viable 41BB-CD19 CAR T-cells per kg body weight.

Locations

Country Name City State
Singapore KK Women's and Children's Hospital Singapore
Singapore Singapore General Hospital Singapore

Sponsors (2)

Lead Sponsor Collaborator
KK Women's and Children's Hospital Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Protocol Feasibility To describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma by assessing number and percentage of enrolled patients who have successful manufacturing of CAR T-cell product, and number and percentage of enrolled patients who go on to receive the CAR T-cell product. 3 years
Secondary Overall Response Rate To evaluate percentage of patients with complete response or partial response at 28 days, 3 months and 6 months post-infusion of the CD19-directed CAR T-cells. 6 months
Secondary Toxicity Evaluations To evaluate overall incidence (percentage of infused patients) of toxicities post-infusion of CAR T-cells, in particular cytokine release syndrome (CRS) and neurotoxicity, and percentage with Grade 3 and above CRS and neurotoxicity following ASTCT definition and severity grading, and other toxicities as assessed by CTCAE v5.0. 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT03671460 - CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL. Phase 1
Recruiting NCT06056752 - QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia Phase 1
Recruiting NCT05016947 - Venetoclax Plus Inotuzumab for B-ALL Phase 1
Suspended NCT01974479 - Pilot Study of Redirected Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia Phase 1
Completed NCT00289562 - Forodesine Hydrochloride (BCX-1777) for B-Cell Acute Lymphoblastic Leukemia Phase 1/Phase 2
Recruiting NCT06034275 - Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies Phase 1
Recruiting NCT04191941 - Treatment of Hematological Malignancy With Novel CAR-T Cells. Early Phase 1
Recruiting NCT05333302 - Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma Phase 1
Recruiting NCT04129099 - A Study of GC022F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL Early Phase 1
Recruiting NCT05651191 - To Evaluate the Safety and Efficacy of Human CD19 Targeted DASH CAR-T Cells Injection for Subjects With R/R B-ALL Early Phase 1
Recruiting NCT04150497 - Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01) Phase 1
Withdrawn NCT05571540 - Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL Phase 1/Phase 2
Recruiting NCT03281551 - Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma Phase 1
Recruiting NCT05379647 - Natural Killer (NK) Cell Therapy for B-Cell Malignancies Phase 1
Withdrawn NCT04156659 - Study of Tisagenlecleucel in Chinese Pediatric and Young Adult Subjects With Relapsed or Refractory B-cell ALL Phase 2
Recruiting NCT04094311 - Study of Out of Specification for Tisagenlecleucel Phase 3
Completed NCT01207388 - Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) Phase 2
Active, not recruiting NCT03467256 - CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL Phase 1/Phase 2
Terminated NCT04844086 - RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies Phase 1
Not yet recruiting NCT04595162 - A Study of GC019F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL Phase 1