Phase 3 CAR-T Trials — Active 2026
These pivotal programs will define how CAR-T moves into earlier lines of hematologic malignancy and into autoimmune disease through 2027–2028.
| NCT ID | Program / Regimen | Sponsor | Indication | Phase |
|---|---|---|---|---|
| NCT04181827 | JNJ-68284528 (ciltacabtagene autoleucel / Carvykti) vs standard | Janssen | Relapsed/refractory multiple myeloma (CARTITUDE-4) | Phase 3 |
| NCT04923893 | VRd followed by Carvykti vs VRd alone (1L myeloma) | Janssen | Newly diagnosed multiple myeloma (CARTITUDE-6) | Phase 3 |
| NCT07391657 | AZD0120 (dual BCMA/CD38 CAR-T) vs standard of care | AstraZeneca | Relapsed/refractory multiple myeloma | Phase 3 |
| NCT07335562 | BMS-986353 (zolacaptogene iraleucel) vs investigator choice CAR-T | Juno / Bristol Myers Squibb | Relapsed/refractory large B-cell lymphoma | Phase 3 |
| NCT06193889 | KYV-101 (anti-CD19 CAR-T) vs standard immunosuppression | Kyverna Therapeutics | Autoimmune disease (KYSA-6) | Phase 3 |
| NCT06799247 | Descartes-08 (mRNA anti-CD19 CAR-T) vs placebo | Cartesian Therapeutics | Generalized myasthenia gravis | Phase 3 |
| NCT07188558 | Ronde-cel (anti-CD19) vs investigator choice CD19 CAR-T | Lyell Immunopharma | Relapsed/refractory large B-cell lymphoma | Phase 3 |
| NCT07441291 | CD19 CAR-T vs donor lymphocyte infusion (DLI) | Peking University People's Hospital | Post-HSCT MRD+ Ph- ALL | Phase 3 |
| NCT06652633 | GLPG5101 (anti-CD19 allogeneic) long-term follow-up | Galapagos NV | B-cell non-Hodgkin lymphoma | Phase 3 |
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Set Up CAR-T WatchlistCAR-T Target Antigens — 2026 Landscape
The approved CAR-T drugs target two antigens. The pipeline targets many more, with particular interest in dual-antigen constructs (to reduce antigen-loss relapse) and B-cell antigens driving autoimmune disease.
Where CAR-T Is Heading: Key 2026 Trends
1. Autoimmune Disease — The Biggest Expansion Opportunity
Multiple early studies have demonstrated that a single CD19 CAR-T infusion can induce sustained, drug-free remission in treatment-refractory SLE, myasthenia gravis, and inflammatory myopathies. The mechanism: deep B-cell depletion followed by immune reset as naive B cells repopulate. Kyverna Therapeutics (KYSA-6, Phase 3) and Cartesian Therapeutics (Descartes-08, Phase 3 in MG) are the furthest along in pivotal trials. If Phase 3 data confirm Phase 1/2 results, CAR-T could enter the autoimmune market — a far larger commercial opportunity than hematologic malignancies.
2. Allogeneic ("Off-the-Shelf") CAR-T
All six approved CAR-T therapies are autologous — made from the patient's own T cells, requiring 3–6 weeks of manufacturing and failing when T-cell quality is poor. Allogeneic CAR-T uses healthy donor T cells edited to prevent graft-versus-host disease, enabling immediate availability and potentially lower cost. Galapagos (GLPG5101), Allogene, and multiple academic programs are in Phase 2/3. Regulatory acceptance of allogeneic T-cell products remains the key open question.
3. Earlier Lines in Hematology
Carvykti and Abecma were initially approved for 4th-line+ multiple myeloma. CARTITUDE-4 data (JNJ-68284528) showed superiority versus standard of care in 2nd-line myeloma. Phase 3 programs are now enrolling newly diagnosed myeloma (1st-line). The commercial prize for 1L myeloma CAR-T is several billion dollars per year in the US alone.
4. Solid Tumors — Still Challenging
CAR-T in solid tumors remains Phase 1/2. The immunosuppressive tumor microenvironment, poor T-cell trafficking, and antigen heterogeneity continue to limit activity. B7-H3, GD2, and mesothelin are the most-advanced solid tumor targets. Some early signals in glioblastoma and neuroblastoma, but no regulatory approvals yet.
Approved CAR-T Therapies — 2026 Reference
| Drug (Generic) | Brand | Target | Sponsor | Approved Indication |
|---|---|---|---|---|
| Tisagenlecleucel | Kymriah | CD19 | Novartis | Pediatric ALL; relapsed/refractory DLBCL and FL |
| Axicabtagene ciloleucel | Yescarta | CD19 | Gilead / Kite | Relapsed/refractory large B-cell lymphoma and FL |
| Brexucabtagene autoleucel | Tecartus | CD19 | Kite / Gilead | Relapsed/refractory mantle cell lymphoma; ALL |
| Lisocabtagene maraleucel | Breyanzi | CD19 | Bristol Myers Squibb | Relapsed/refractory large B-cell lymphoma (2L+) |
| Ciltacabtagene autoleucel | Carvykti | BCMA | Janssen / Legend | Relapsed/refractory multiple myeloma (2L+) |
| Idecabtagene vicleucel | Abecma | BCMA | Bristol Myers Squibb | Relapsed/refractory multiple myeloma (4L+) |
Frequently asked questions
Related Clinical Trial Trackers
- Multiple Myeloma Clinical Trials — 600+ active studies, BCMA and GPRC5D CAR-T pipeline
- DLBCL Clinical Trials — DLBCL first-line and relapsed/refractory pipeline
- Acute Lymphoblastic Leukemia Clinical Trials — CD19 CAR-T is standard of care in R/R B-ALL
- Non-Hodgkin Lymphoma Clinical Trials — 300+ active NHL studies including approved CAR-T indications
- BTK Inhibitor Clinical Trials — Competing and complementary mechanism in hematologic malignancies
- ADC Clinical Trials — 108+ active antibody-drug conjugate studies across oncology
949 active trials, 598 recruiting. Phases: Early Phase 1: 150, Phase 1: 516, Phase 2: 274, Phase 3: 18, Phase 4: 2.
| Trial | Status | Latest tracked change | Seen |
|---|---|---|---|
| Phase I/II Open-label Study Evaluating The Safety And Efficacy of Concomitant… NCT06762431 | Recruiting | Primary completion pushed: 2026-03-09 → 2026-08-09 | 2026-08-11 |
| Autoimmune Disease Treatment With Mesenchymal Stem Cells (MSCs) and CAR-T Cells NCT06435897 | Not Yet Recruiting | Completion pushed: 2027-12-31 → 2029-12-31 | 2026-08-28 |
| 19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell… NCT04464200 | Active, Not Recruiting | Completion pushed: 2026-07 → 2027-07 | 2026-08-28 |
| Universal CAR-T Cells Targeting Multiple Myeloma NCT06006741 | Not Yet Recruiting | Completion pushed: 2026-12-31 → 2028-12-31 | 2026-08-27 |
| Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the… NCT06711146 | Recruiting | Primary endpoint(s) modified | 2026-08-25 |
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