Paul G. Rubinstein, MD, drew a line in the sand: “No one should be excluded from any clinical trial.” Cooperative groups have picked up that challenge, moving to include patients with HIV-associated lymphoma in studies once closed to them. The days when HIV status meant an automatic rejection from cancer trials are fading fast.
For a long stretch, people living with HIV hit a wall when trying to join trials for CAR T cells or bispecific antibodies. Now, research networks are tearing down those barriers. Patients who spent years on the outside are finally getting a shot at new therapies.
The phase 1 AMC-112 trial is the first prospective study to evaluate the safety and feasibility of axicabtagene ciloleucel (Yescarta) CAR-T therapy specifically in patients with controlled HIV infection and relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
Expanding Access to Advanced Therapies
Rubinstein has pressed for this change, pointing out how cooperative groups are widening the net for CAR T and bispecific antibody research. Including patients with HIV-associated lymphoma is more than a gesture. It’s a direct push to gather real-world safety and efficacy data for a group that has been left out for too long.
Veronika Bachanova, MD, PhD, put the spotlight on natural killer (NK) cells in cancer therapy. “Those of us who work with NK cells have no doubt that they are incredibly powerful at killing cancer cells.” Her confidence in cell-based immunotherapies is clear, but she also flagged the trade-offs: CAR NK cell therapies might be safer, yet that could mean less durable responses over time.
Clinical Evidence and Patient Experience
Patient care details are getting more attention. Allen Khodab, MD, described how men with larger prostates saw their IPSS scores drop, eventually matching those with normal-sized glands. It’s a reminder that clinical outcomes rarely fit a single pattern. Jeffrey V. Matous, MD, pointed to the importance of ramantamig’s MRD negativity rates in relapsed or refractory myeloma and discussed how to help patients manage chronic, low-grade toxicities so they stick with treatment.
This push for broader access is gaining ground. As previous reporting shows, enrolling people with HIV in CAR T and bispecific antibody trials is already challenging old assumptions. The data so far show these patients can safely join advanced studies.
Historically, people with HIV were excluded from pivotal CAR-T trials that led to FDA approvals for CD19-directed therapies in relapsed or refractory B-cell lymphomas, meaning initial safety and efficacy data for this population relied mainly on retrospective analyses rather than randomized registration studies.
Editorial Perspective
Momentum for inclusive research is building. By focusing on access and evidence for HIV-associated lymphoma patients, cooperative groups are correcting old gaps in cancer care. Refusing to accept exclusion as the norm is changing how trials are designed and who gets a seat at the table.
In a matched retrospective analysis from the AIDS Malignancy Consortium and the Center for International Blood and Marrow Transplant Research, 35 HIV-positive patients who received CD19-directed CAR-T therapy between August 2017 and November 2024 were compared to 135 HIV-negative controls. Cytokine release syndrome of any grade showed up less often in the HIV-positive group (68.6% vs. 82.2%, P=0.04). This finding underscores why prospective safety data matter for this population, as detailed in a Cancer Network report.
Current reviews point out that clinical data on CAR-T therapy for HIV-associated diffuse large B-cell lymphoma are still thin, mostly limited to case reports and small series. Extra risks for these patients include infectious complications and effects of prior treatments, along with underlying immune dysfunction, as outlined in a Diagnostics (MDPI) review.
