CAR T-cell therapy for relapsed B-lineage leukemia and lymphoma
Official title: CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
Run by KK Women's and Children's Hospital · NCT05648019 · Data updated 2026-11-12
This study is testing if a new CAR T-cell therapy can be safely given to patients with relapsed B-lineage leukemia and lymphoma to see how well it works.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 0 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | KK Women's and Children's Hospital Government |
| Drugs / interventions | CAR T |
| Locations | 2 sites (Singapore and 1 other locations) |
| Status | Recruiting |
| Started | March 15, 2022 |
| Main results expected | December 2025 |
| Study ends | December 2026 |
| Registry record updated | March 9, 2023 |
| Trial ID | NCT05648019 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients under 18 years or adults with relapsed or refractory B-cell acute lymphoblastic leukemia or large B-cell lymphoma who have undergone multiple lines of systemic therapy.
✕Probably not a fit
Patients with non-B-lineage leukemias or lymphomas, or those who are not relapsed or refractory, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the feasibility of delivering CD19-directed CAR T-cell therapy to patients with relapsed or refractory B-lineage leukemia and lymphoma. It is a single-arm, open-label, multi-center phase II study that includes several phases: screening for eligibility, a preparatory phase involving leukapheresis and CAR T-cell manufacturing, a treatment phase with a single dose infusion of CAR T-cells, and a follow-up phase for monitoring efficacy and safety for up to 24 months. The goal is to assess how well this therapy can be administered in a point-of-care setting.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat relapsed or refractory B-lineage leukemia and lymphoma.
How similar studies have gone: Other studies using CAR T-cell therapy for similar conditions have shown promising results, indicating that this approach is gaining traction in the treatment of hematological malignancies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Singapore General Hospital
Singapore, Singapore Recruiting -
KK Women's and Children's Hospital
Singapore, Singapore Recruiting
Study contacts
- Principal investigator: Shui Yen Soh, MD — KK Women's and Children's Hospital
- Study coordinator: Shui Yen Soh, MD
- Email: soh.shui.yen@singhealth.com.sg
- Phone: +65 6394 1045
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Gene therapy for certain blood cancers
This study is testing a new gene therapy called VNX-101 to see if it can help people with certain types of blood cancers that haven't responded to other treatments.
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CD19 and CD22 in vivo CAR-T therapy for relapsed/refractory B-ALL
This study tests a one-of-a-kind in vivo CAR-T treatment that targets CD19 first and then CD22 in adults with relapsed or refractory B-ALL to see if it is safe and possibly effective.
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GI001 CAR-T for relapsed or refractory B-cell NHL and B-ALL
This treatment study tests GI001, an in vivo CAR-T therapy, to see if it is safe and helpful for adults with relapsed or refractory B-cell NHL or B-ALL.
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Umbilical Cord Blood CAR-T Cells Targeting CD19 and CD22 for relapsed/refractory B-ALL
This phase 1 study tests whether dual-target cord blood-derived CAR-T cells against CD19 and CD22 are safe and tolerable in adults with relapsed or refractory B-cell ALL.
-
Glofit-GemOx Bridging to Liso-cel for Relapsed/Refractory Large B-Cell Lymphoma
This trial tests whether a bridging therapy with Glofit-GemOx followed by lisocabtagene maraleucel helps people with relapsed or refractory large B-cell lymphoma.
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Dual-target CD22/CD19 CAR-T consolidation after first remission in high-risk B-ALL
This test will try a dual-target CD22/CD19 CAR-T cell treatment as consolidation for patients with high-risk B-cell acute lymphoblastic leukemia who are in their first remission.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.