Clinical trial · Interventional
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Relapsed or Refractory T or B Cell Malignancies
NCT04502446CI-TRIAL-00084437terminatedPhase 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): Patients to be followed up in the CRSP-ONC-LTF study
Summary
Brief summary (as posted)
This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.
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 |
|---|---|---|---|
| T Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CTX130 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CTX130
- description
- Administered by IV infusion following lymphodepleting chemotherapy.
- interventionNames
- Biological: CTX130
Primary outcomes (2)
- measure
- Part A (dose escalation)
- timeFrame
- From CTX130 infusion up to 28 days post-infusion
- description
- Incidence of adverse events
- measure
- Part B (cohort expansion)
- timeFrame
- From CTX130 infusion up to 60 months post-infusion]
- description
- Objective response rate
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (abbreviated): 1. Age ≥18 years. 2. Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Adequate renal, liver, cardiac, and pulmonary organ function. 5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX130 infusion. Exclusion Criteria (abbreviated): 1. Prior allogeneic stem cell transplant (SCT). 2. Prior treatment with any anti-CD70 targeting agents. 3. History of certain central nervous system (CNS), cardiac or pulmonary conditions. 4. Active HIV, hepatitis B virus or hepatitis C virus infection. 5. Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for \>12 months, or any other localized malignancy with low risk of developing into metastatic disease. 6. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 7. Prior solid organ transplantation. 8. Pregnant or breastfeeding females.
References
Publications (2)
- DERIVEDIyer SP, Sica RA, Ho PJ, Prica A, Zain J, Foss FM, Hu B, Beitinjaneh A, Weng WK, Kim YH, Khodadoust MS, Huen AO, Williams LM, Ma A, Huang E, Ganpule A, Nagar SD, Sripakdeevong P, Cullingford EL, Karnik S, Dequeant ML, Patel JN, He XS, Li Z, He QA, Mendonez JH, Keegan A, Horwitz SM. Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study. Lancet Oncol. 2025 Jan;26(1):110-122. doi: 10.1016/S1470-2045(24)00508-4. Epub 2024 Nov 29. PMID 39617017
- DERIVEDDewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3. PMID 37093350