Clinical trial · Interventional
Phase I Study of JWCAR029 in Subjects With R/R CLL/SLL
An Open Label, Single-arm, Phase I Study of JWCAR029 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT05259813CI-TRIAL-00071656withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to the COVID-19 pandemic,no subjects enrolled
Summary
Brief summary (as posted)
This is a Phase I, open-label, single-arm, single center study to assess the safety and efficacy of JWCAR029 in subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JWCAR029 (Relmacabtagene Autoleucel) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JWCAR029 Treatment
- description
- Dose-finding for JWCAR029 monotherapy
- interventionNames
- Genetic: JWCAR029 (Relmacabtagene Autoleucel)
Primary outcomes (2)
- measure
- Treatment-related adverse events (AEs)
- timeFrame
- 2 years
- description
- Type, Proportion, and Severity
- measure
- Recommended dose of JWCAR029
- timeFrame
- 28 days after JWCAR029 infusion
- description
- Recommended dose of JWCAR029
Secondary outcomes (12)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years old and ≤ 75 years old; * Sign on the informed consent; * Diagnosis of: 1. CLL with an indication for treatment based on iwCLL 2018 and measurable disease, or 2. SLL (lymphadenopathy and/or splenomegaly and \< 5×10\^9 CD19+ CD5+ clonal B lymphocytes/L \[\< 5000/µL\] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL); * Relapsed/refractory patients, Subjects must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Expected survival is greater than 12 weeks; * Adequate organ function; * Adequate vascular access for leukapheresis procedure; * Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029. Exclusion Criteria: * Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma; * History of another primary malignancy that has not been in remission for at least 2 years; * Subjects has HBV, HCV, HIV or syphilis infection at the time of screening; * Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; * Subjects with uncontrolled systemic fungal, bacterial, viral or other infection; * Presence of acute or chronic graft-versus-host disease (GVHD); * History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; * Pregnant or nursing women; * Subjects using of any chemotherapy, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; * Received allo-hematopoietic stem cell transplantation therapy previously. * Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; * Received CAR T-cell or other genetically-modified T-cell therapy previously.
References
Publications (0)
Data not yet available
No reference posted for this study.